scholarly journals Research Staff Perspectives on Cancer Clinical Trials and Barriers to Recruitment: A Qualitative Research

2021 ◽  
Author(s):  
Amany R. Keruakous ◽  
Silas Day ◽  
Kenny D. Garcia-Ramiu ◽  
Melissa Yarbrough ◽  
Adam S. Asch
Keyword(s):  
Clinical Trial ◽  
Qualitative Research ◽  
Clinical Trials ◽  
Performance Status ◽  
Cultural Beliefs ◽  
Research Staff ◽  
Financial Barriers ◽  
Clinical Trials Enrollment ◽  
New Perspective ◽  
And Performance

Abstract Study objectives-Highlight common barriers to recruiting adults' cancer patients, encountered by research coordinators from all disease sites-Propose effective solutions to identified barriers.Results We are reporting our results of a qualitative research methodology investigating barriers to clinical trials enrollment from a new perspective. The most commonly reported obstacles, for clinical trials enrollment, from our research staff perspective were categorized into five themes: clinical trials protocol, communication barriers and cultural beliefs, financial barriers, patients' comorbidities and performance status, and physicians’ commitment. Assessing barriers encountered by clinical research staff is infrequently used as a metric for improving clinical trial enrollment, but provides important perspective. Interventions to improve clinical trial feasibility and accrual are critical to improve cancer care.

Safety and efficacy outcomes with nivolumab plus ipilimumab in patients with advanced renal cell carcinoma and low Karnofsky performance status: Results from the CheckMate 920 trial.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 315-315
Author(s):  
Thomas E. Hutson ◽  
Bradley Curtis Carthon ◽  
Jeffrey Yorio ◽  
Sunil Babu ◽  
Heidi Ann McKean ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Clinical Trials ◽  
Adverse Events ◽  
Clear Cell ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Objective Response ◽  
Safety And Efficacy ◽  
Grade 3

315 Background: Combination therapy with nivolumab + ipilimumab (NIVO+IPI) has demonstrated long-term efficacy and tolerability for patients (pts) with previously untreated advanced renal cell carcinoma (aRCC). Most pivotal clinical trials in pts with aRCC have excluded pts with low Karnofsky performance status (KPS; < 70%). CheckMate 920 is a multi-arm, phase IIIb/IV, open-label clinical trial of NIVO+IPI treatment in pts enrolled in a community practice setting with aRCC and a high unmet medical need. We present safety and efficacy results for the cohort of pts with aRCC of any histology and KPS 50%–60% from CheckMate 920 (NCT02982954). Methods: Pts with previously untreated advanced/metastatic RCC and KPS 50%–60% received NIVO 3 mg/kg + IPI 1 mg/kg Q3W × 4 doses followed by 480 mg NIVO Q4W for ≤ 2 years or until disease progression/unacceptable toxicity. The primary endpoint was incidence of grade ≥ 3 immune-mediated adverse events (imAEs) within 100 days of last dose of study drug. Key secondary endpoints included progression-free survival (PFS) and objective response rate (ORR) by RECIST v1.1 (both per investigator). Exploratory endpoints included overall survival (OS). Results: Of 25 treated pts with KPS 50%–60%, 76% were men; median age was 67 years (range, 34–81). IMDC risk was favorable in 0%, intermediate in 32%, and poor in 68% of pts; 84% had clear cell and 16% had non-clear cell RCC histology. With a minimum follow-up of 25 months, median duration of therapy (95% CI) was 2.3 months (2.1–7.7) for NIVO and 2.1 months (2.1–2.1) for IPI. The median number of doses (range) received was 4 (1–27) for NIVO and 4 (1–4) for IPI; 76% of pts received ≥ 4 NIVO doses and 68% received all 4 IPI doses. The only grade 3–4 imAEs by category were hepatitis (4.0%) and adrenal insufficiency (4.0%). No grade 5 imAEs occurred. Overall, 4 (16%) pts discontinued due to any-grade adverse events (n = 1 each for elevated AST, malignant neoplasm progression, back pain, and acetabulum fracture). Of 18 evaluable pts, ORR was 33.3% (95% CI, 13.3–59.0); no pts had a complete response and 6 had partial response. Median time to objective response was 4.5 months (range, 2.5–24.7). Median duration of objective response was 20.6 months (range, 0.03+–24.2+). Median PFS was 4.6 months (95% CI, 2.5–14.8). Median OS was 15.6 months (95% CI, 5.3–25.1). Conclusions: NIVO+IPI demonstrated an acceptable safety profile and promising antitumor activity in pts with previously untreated aRCC and KPS 50%–60%. The combination was tolerated at a dose intensity similar to that observed in clinical trials conducted in pts with higher KPS (≥ 70%). These data support the value of NIVO+IPI in pts who may not be considered ideal candidates for this therapy and consequently may have limited treatment options. Clinical trial information: NCT02982954 .

scholarly journals Provider Recommendations for Phase I Clinical Trials Within a Shared Decision-Making Model in Phase I Cancer Clinical Trial Discussions

2020 ◽  
Vol 16 (9) ◽  
pp. e859-e867
Author(s):  
Rachel S. Hianik ◽  
Gavin P. Campbell ◽  
Eli Abernethy ◽  
Colleen Lewis ◽  
Christina S. Wu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Phase I ◽  
Shared Decision Making ◽  
Phase I Trial ◽  
Performance Status ◽  
Shared Decision ◽  
Phase I Clinical Trials ◽  
Decision Making Model

PURPOSE: Debate continues over whether explicit recommendations for a clinical trial should be included as an element of shared decision making within oncology. We aimed to determine if and how providers make explicit recommendations in the setting of phase I cancer clinical trials. METHODS: Twenty-three patient/provider conversations about phase I trials were analyzed to determine how recommendations are made and how the conversations align with a shared decision-making framework. In addition, 19 providers (9 of whose patient encounters were observed) were interviewed about the factors they consider when deciding whether to recommend a phase I trial. RESULTS: We found that providers are comprehensive in the factors they consider when recommending clinical trials. The two most frequently stated factors were performance status (89%) and patient preferences (84%). Providers made explicit recommendations in 19 conversations (83%), with 12 of those being for a phase I trial (12 [63%] of 19). They made these recommendations in a manner consistent with a shared decision-making model; 18 (95%) of the 19 conversations during which a recommendation was made included all steps, or all but 1 step, of shared decision making, as did 11 of the 12 conversations during which a phase I trial was recommended. In 7 (58%) of these later conversations, providers also emphasized the importance of the patient’s opinion. CONCLUSION: We suggest that providers not hesitate to make explicit recommendations for phase I clinical trials, because they are able to do so in a manner consistent with shared decision making. With further research, these results can be applied to other clinical trial settings.

Clinical trial eligibility determination using an oncology electronic medical record system interfaced to a caBIG-certified trial database

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6626-6626
Author(s):  
J. W. Goldwein ◽  
M. Van Der Pas ◽  
L. Tis ◽  
R. Nickens ◽  
R. Comis
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Record ◽  
Electronic Medical Record ◽  
Performance Status ◽  
Stage Iv ◽  
Clinical Trial Registration ◽  
Record System ◽  
Eligibility Determination ◽  
Stage Iv Breast Cancer

6626 Background: One reason for the low numbers of patients entered on cancer clinical trials is the difficulty and inconvenience encountered in determining whether patients are eligible. The introduction of electronic medical record (EMR) systems in cancer facilities provides a means by which clinical parameters may be electronically collected and compared against clinical trial eligibility criteria, with the potential to facilitate eligibility determination. We hereby describe a widely utilized EMR system interfaced to a caBIG-certified searchable clinical trials database which facilitates eligibility determination. Materials and Methods: MOSAIQ is a widely utilized oncology- specific EMR system that is operational in radiation and medical oncology facilities world-wide. During the routine course of patient care, clinical trial eligibility parameters such as diagnosis, stage, age, and performance status are entered into defined data fields within the EMR. Trialcheck is an independently maintained caBIG bronze level certified database that lists thousands of clinical trials from Cooperative Groups, NCI/PDQ, the pharmaceutical industry and trials being conducted exclusively at particular oncology facilities. TrialCheck registrants can screen trials for patient eligibility as well as filter and track the status of trials that have been activated at their facility. In addition, a real-time, secure Internet interface between MOSAIQ and TrialCheck extracts eligibility parameters from a patient record, sends that information to TrialCheck, and returns a listing of matched clinical trials. Results: In a test screen of 4 MOSAIQ EMR patients against 257 TrialCheck clinical trials, the system matched a patient with Stage IV breast cancer to 7 available trials in less 2 seconds, a patient with Stage IIIB colon cancer to 3 trials in 5 seconds, a Stage IV prostate cancer to 5 trials in 4.4 seconds, and a patient with stage II esophageal cancer to 2 trials in 3.7 seconds. Conclusion: This product demonstrates a novel and innovative solution to one of the problems inherent in the clinical trial registration process in an efficient, reliable and secure manner. No significant financial relationships to disclose.

Phase II trial of combination therapy with intravenous carboplatin (C) and oral everolimus (EVE) and prednisone (P) in docetaxel-pretreated (DP) metastatic castrate-resistant prostate cancer (mCRPC): A Prostate Cancer Clinical Trial Consortium study.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 156-156
Author(s):  
Muthu Kumaran Veeraputhiran ◽  
Daniel H. Shevrin ◽  
Lance K. Heilbrun ◽  
Daryn Smith ◽  
Jing Li ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Performance Status ◽  
Mtor Inhibition ◽  
Measurable Disease ◽  
Grade 3 ◽  
And Performance ◽  
Castrate Resistant

156 Background: Platinum based therapies have demonstrated efficacy in DP mCRPC. EVE demonstrated preclinical efficacy in chemotherapy resistant prostate cancer models. Clinical synergy was noted between C and EVE, hence a phase II trial of the combination was conducted. Methods: Primary endpoint was time to progression (TTP). Progression was defined per RECIST criteria for measurable disease (MD), or skeletal event, or > 2 new areas of bone metastases. DP mCRPC patients with adequate renal and liver function, and performance status of 0 or 1 were eligible. Intravenous C at target AUC of 5 on day 1, and oral EVE 5mg once daily and P 5mg twice daily were administered in 21 day cycles. PSA was assessed every 21 days and radiologic response was assessed every 3 cycles. Secondary endpoints included overall survival (OS), correlation of TTP and PSA response, with markers such as phopho mTOR, pAKT, p70S6 and circulating tumor cells (CTC). Results: 26 patients (pts) enrolled, including 8 African Americans, and accrual is complete. Median age was 69 years (range 54-86). Median pretherapy PSA was 190 ng/ml (range 13 - 2174). 18 pts (69%) had bone pain. Gleason score was > 8 in 18 pts. 19 pts had measurable disease of which 15 had MD progression, 18 had bone scan progression, and 2 had PSA-only progression. 124 cycles have been administered; median 3 cycles (range 1 - 16). The predominant grade 3 or 4 toxicities were thrombocytopenia in 8 pts, pulmonary embolism in 2 and neutropenia in 3. No treatment related deaths occurred. Of 26 pts who are response evaluable, 4 (15%) had a > 30% PSA decline and 1 had a >90% PSA decline. Of 19 pts with MD, 8 had stable disease and no objective responses were observed. The median TTP and OS were 2.5 months (90% CI: 1.8 - 4.3), and 12.5 months (90% CI: 6.7 - 16.1), respectively. Correlative studies including pharmacokinetic and pharmacodynamic evaluations are ongoing, and will be reported. Conclusions: The combination was tolerable but revealed modest clinical efficacy. Biomarker evaluation may help identify a subset likely to benefit from mTOR inhibition strategy in mCRPC. Clinical trial information: NCT01051570.

Comparison of attitudes and beliefs about cancer clinical trial enrollment between physicians, research staff, and cancer patients.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 170-170
Author(s):  
Grace Hillyer ◽  
Melissa Beauchemin ◽  
Dawn L. Hershman ◽  
Moshe A. Kelsen ◽  
Frances L Brogan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Online Survey ◽  
Cancer Clinical Trial ◽  
Cultural Barriers ◽  
Attitudes And Beliefs ◽  
Research Staff ◽  
Hispanic Patients ◽  
Clinical Trial Enrollment

170 Background: Essential to bringing innovative cancer treatments to patients is voluntary participation in clinical trials but fewer than 10% of cancer patients are enrolled onto a trial. We used a domain-oriented framework to assess barriers to cancer clinical trial enrollment (CTE). Methods: Physicians and research staff completed an online survey in 2017; adult cancer patients not currently enrolled in a trial were interviewed in 2018. Perceived structural, provider- and patient-level barriers to CTE were assessed. Differences in perceptions, attitudes and beliefs toward CTE between physicians and staff, patients by ethnicity, and physicians/staff and patients were examined. Results: In total, 120 physician/staff (64.4% response rate) and 150 cancer patient completed surveys. Interacting with the patients’ family was seen as a CTE barrier by nearly one-third of physicians/staff overall, however, staff much more often stated this barrier than did physicians (44.0% vs. 18.2%, p= 0.007). Hispanic patients more often stated they would join a trial, even if standard therapy was an option compared to non-Hispanic patients ( p= 0.004). Overall, patients, more often than physicians/staff, believed that clinical trials are only offered to people whose disease is hopeless (27.3% vs. 8.7%, p < 0.001) and that CTE does not help patients personally (32.9% vs. 1.8%, p < 0.001). More often physicians/staff believed that patients decline CTE due to language or cultural barriers (57.5% vs. 27.3%, p < 0.001), lack of understanding about clinical trials (63.3% vs. 9.1%, p = 0.001), and mistrust of the medical system (69.2% vs. 36.4%, p= 0.043) than was reported by patients. Patients less often reported declining CTE because of concerns about invasive procedures (9.1% vs. 41.7%, p = 0.02), toxicity (18.2% vs. 60.0%, p= 0.006) or reluctance to be randomized/receive a placebo (27.3% vs. 70.8%, p= 0.005). Conclusions: Our findings indicate a wide gap between provider and patient attitudes and beliefs about CTE. Reconciling these differences will require tailored education to dispel misperceptions and strategies to improve the quality of patient-provider communication.

scholarly journals Research Staff Perspectives on Cancer Clinical Trials and Barriers to Recruitment: A Qualitative Research

Cureus ◽  
2021 ◽  
Author(s):  
Amany R Keruakous ◽  
Silas Day ◽  
Kenny Garcia-Ramiu ◽  
Melissa Yarbrough ◽  
Adam S Asch
Keyword(s):  
Qualitative Research ◽  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Research Staff

Evaluation of barriers to clinical trial enrollment through a novel pharmacy quality assurance tool

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 17026-17026
Author(s):  
D. C. Vamos ◽  
M. P. Kane ◽  
J. Nishioka ◽  
S. Lisi ◽  
J. R. Neceskas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Performance Status ◽  
Pharmacy Service ◽  
Cancer Center ◽  
Limiting Factor ◽  
Available N ◽  
Patients With Cancer ◽  
Barriers To Enrollment ◽  
Pharmacy Quality

17026 Background: Clinical trials offer the best treatment for patients with cancer, yet less than 5 percent of adults and less than 60 percent of children are enrolled on clinical trials. To determine reasons for lack of enrollment on clinical trials and to assess areas for potential trial development, we designed a ‘non-protocol’ form for use at our center. Our goal was to assess deficiencies in our menu of trials, identify other barriers to enrollment, and to indirectly increase awareness of trials. Methods: Completion of a ‘non-protocol’ form was required by the pharmacy with the first set of new chemotherapy orders for all Cancer Institute of New Jersey ambulatory patients who were not enrolled on a clinical trial. The form required completion of one of three areas for lack of enrollment: trial availability, reason for ineligibility, or other reason for not enrolling the patient. Results: From June 2003 through December 2005, 474 forms were collected for patients not enrolled on a clinical trial. The median age of patients not enrolled on trial was 56 years (range 1 to 88 years) and females outnumbered males (69% vs 31%). Lack of trial availability limited enrollment for 51% of patients (n=241) while administration of standard therapy was listed for 10 patients. Of those patients where a trial was available (n=223), 65% (n=145) of patients were not eligible, most commonly due to performance status (n=55). The remaining 78 patients refused participation. To determine if implementation of this pharmacy service changed the reasons for lack of enrollment, the data was evaluated by year: Conclusion: Lack of trial availability has been a rate-limiting factor in enrollment on clinical trials at our center. The data generated from the implementation of this novel pharmacy service is of strategic importance to the center. It is reviewed with the tumor-focused groups of the cancer center to identify areas for developing clinical trials. [Table: see text] No significant financial relationships to disclose.

Safety and efficacy of nivolumab plus ipilimumab (NIVO+IPI) in patients with advanced renal cell carcinoma (aRCC) with brain metastases: Interim analysis of CheckMate 920.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4517-4517 ◽  
Author(s):  
Hamid Emamekhoo ◽  
Mark Olsen ◽  
Bradley Curtis Carthon ◽  
Alexandra Drakaki ◽  
Ivor John Percent ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Antitumor Activity ◽  
Brain Metastases ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Objective Response ◽  
Safety And Efficacy ◽  
Immune Mediated ◽  
Grade 3

4517 Background: Previous clinical trials of patients (pts) with aRCC, including CheckMate 214, have mostly excluded pts with brain metastases. However, antitumor activity in pts with brain metastases has been observed in pts with melanoma treated with NIVO 1 mg/kg + IPI 3mg/kg and pts with non-small cell lung cancer treated with NIVO 240 mg + IPI 1mg/kg. CheckMate 920 is an ongoing, phase 3b/4 clinical trial of NIVO + IPI treatment in pts with aRCC with a high unmet medical need. Here, we present the safety and efficacy interim results for the cohort of pts with brain metastases. Methods: Pts with previously untreated aRCC of any histology, with asymptomatic brain metastases (not on corticosteroids or receiving radiation), and Karnofsky performance status ≥70% were assigned to treatment with NIVO 3 mg/kg + IPI 1 mg/kg every 3 weeks for 4 doses, followed by NIVO 480 mg every 4 weeks. Pts were treated until disease progression, unacceptable toxicity, or for a maximum of 2 years. The primary endpoint was the incidence of high-grade immune-mediated adverse events (IMAEs). Key secondary endpoints included progression-free survival (PFS) and objective response rate (ORR) by RECIST v1.1 per investigator. Exploratory endpoints included additional safety analyses and overall survival (OS). Results: Overall, 28 patients were enrolled in the brain metastases cohort. With a minimum follow-up of 6.47 months, grade 3-4 IMAEs within 100 days of last dose were reported in 6 cases. The grade 3-4 IMAEs observed in ≥ 1 patient were diarrhea, colitis, diabetic ketoacidosis, immune-mediated hepatitis, hypophysitis, and rash of any type (n = 1 each). No treatment-related grade 5 IMAEs were reported. ORR by RECIST v1.1 per investigator in all treated subjects was 28.6% (95% CI 13.2–48.7). Median PFS in all treated subjects was 9.0 months (95% CI 2.9–not estimable [NE]). Median OS has not been reached (95% CI 13.1–NE). Conclusions: In pts with aRCC and brain metastases who are often excluded from clinical trials, NIVO + IPI treatment showed a safety profile consistent with previous reports of this dosing regimen, with encouraging antitumor activity. Clinical trial information: NCT02982954.

Prevalence of PD-L1 expression in first-line (1L) locally advanced/unresectable or metastatic urothelial carcinoma (UC).

2019 ◽  
Vol 37 (8_suppl) ◽  
pp. TPS67-TPS67
Author(s):  
Petros Grivas ◽  
Alicia K. Morgans ◽  
Yair Lotan ◽  
Jeffrey P. Gregg ◽  
Daniel M. Geynisman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Tumor Tissue ◽  
Performance Status ◽  
Locally Advanced ◽  
Circulating Tumor Dna ◽  
Mutational Burden ◽  
Platinum Based Chemotherapy ◽  
Tumor Mutational Burden ◽  
Pre Treatment ◽  
And Performance

TPS67 Background: Treatments for 1L advanced/metastatic UC include platinum-based chemotherapy, an immune checkpoint inhibitor (ICI) or clinical trial enrollment. Not all patients benefit from, or are eligible for, specific therapies due to comorbidities and performance status. There is an urgent need for biomarker-directed strategies to enable patient selection and improve outcomes. Currently the only clinically used molecular biomarker is PD-L1 protein expression in tumor tissue. Although inconsistent and variable among assays, higher PD-L1 expression generally correlates with increased ICI response rate. Improved understanding of the prevalence and potential prognostic and/or predictive role of PD-L1 can further enhance its clinical utility and guide novel clinical trial designs. Methods: This observational study will enroll 250 patients with advanced UC prior to starting or during 1L therapy, as initiated at the discretion of participating clinicians, from 60 US community sites. The primary endpoint is prevalence of PD-L1 expression by VENTANA SP263 Assay (exact [Clopper-Pearson] 95% CI) on pre-treatment tumor tissue. Secondary endpoints include the association of pre-treatment PD-L1 expression with pre-treatment tumor tissue mutational burden (tTMB), descriptions of treatment response and outcomes (ORR based on RECIST 1.1, PFS, OS) and assessment of their correlations with PD-L1 expression. Exploratory endpoints include the association of pre-treatment tumor tissue PD-L1 with pre-treatment blood-based tumor mutational burden (bTMB), changes in circulating tumor DNA (ctDNA) levels at various timepoints, the correlation between tTMB and bTMB values, and the association of those biomarkers for outcomes of PFS and OS. Enrollment will take place over 24 months with follow-up to 30 months from study enrollment. With 250 patients, the 95% CI for 30%, 45%, and 60% observed prevalence of PD-L1 high are (24.4%, 36.1%), (38.9%, 51.2%), and (53.6%, 66.1%), respectively; the various secondary and exploratory analyses will be descriptive.

MONARCC: A randomized phase II study of panitumumab monotherapy and panitumumab (pan) plus 5 Fluorouracil (FU) as first-line therapy for RAS and BRAF wild type metastatic colorectal cancer (mCRC): An AGITG clinical trial.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. TPS271-TPS271
Author(s):  
Niall C. Tebbutt ◽  
Christopher B. Steer ◽  
Katrin Marie Sjoquist ◽  
Lorraine A. Chantrill ◽  
Christos Stelios Karapetis ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Primary Tumour ◽  
Performance Status ◽  
Health Assessment ◽  
Wild Type ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
The Impact

TPS271 Background: Pan added to combination chemotherapy is established first-line therapy for RAS and BRAF wild type mCRC. Elderly patients are not well represented in clinical trials and may be more suited to treatment protocols with lower toxicity risks; FU plus bevacizumab (bev) is commonly used. Treatment related efficacy, toxicity, impact on quality of life and other outcomes of pan based regimens in an elderly population have not been well studied. Methods: A prospective non-comparative randomized phase 2 study. Australian Clinical Trials Registry Number: ACTRN 12618000233224. Main inclusion criteria include: Untreated patients aged 70 years or older; RAS and BRAF wild type; ECOG performance 0-2. Randomisation 1:1, stratified by primary tumour side, performance status, number of metastatic sites; to pan 6mg/kg 2 weekly or panitumumab plus FU 400 mg/m² bolus; leucovorin 200mg/m²; FU 2400mg/m² 48 hour infusion 2 weekly. Primary endpoint is 6-month progression-free survival (PFS). Sample size is 80 patients based on expected 6-month PFS rate of 73% with FU and bev. Using the method of Metha-Cain, if 24 or more patients are progression free at 6 months, the one sided 95% confidence interval includes 73% and we declare similar activity. Secondary endpoints include overall survival; toxicity and overall treatment utility, a composite measure of treatment benefit based on radiology, clinical progress, toxicity and patient reflection of the impact of treatment on their daily lives. Patients undergo a comprehensive health assessment at baseline and limited health assessment at 4 months. Physical activity trackers are worn for 2 weeks at treatment commencement and again at week 16. Tumour tissue and blood samples (at baseline, cycle 3 day 1 and at 24 weeks) will be collected for translational research. First site opened in June 2018. Twelve patients have been recruited to date from 9 sites in Australasia. Eighteen sites were open as at September 2019. Clinical trial information: 12618000233224.

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