scholarly journals Phase 2 Multicenter Clinical Trial of Bone Marrow–Sparing Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage IB-IVA Cervical Cancer

2016 ◽  
Vol 96 (2) ◽  
pp. S13 ◽  
Author(s):  
L.K. Mell ◽  
I. Sirak ◽  
L. Wei ◽  
R.R. Tarnawski ◽  
U.M. Mahantshetty ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cervical Cancer ◽  
Bone Marrow ◽  
Radiation Therapy ◽  
Intensity Modulated Radiation Therapy ◽  
Phase 2 ◽  
Multicenter Clinical Trial ◽  
Intensity Modulated ◽  
Stage Ib ◽  
Bone Marrow Sparing

Phase III randomized trial of image-guided bone marrow-sparing intensity modulated radiation therapy (IG-BMS-IMRT) for locoregionally advanced cervical cancer: The INTERTECC-3 trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS5600-TPS5600
Author(s):  
Loren K. Mell ◽  
Igor Sirak ◽  
Lorraine Portelance ◽  
Aaron Howard Wolfson ◽  
Alexandra J. Stewart ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cervical Cancer ◽  
Bone Marrow ◽  
Intensity Modulated Radiation Therapy ◽  
Phase Iii ◽  
Image Guided ◽  
Intensity Modulated ◽  
Stage Ib ◽  
Bone Marrow Sparing ◽  
The U.S

TPS5600 Background: Cervical cancer is a leading cause of cancer death in women worldwide. Image-guided bone marrow-sparing intensity modulated radiation therapy (IG-BMS-IMRT) has shown potential to reduce acute toxicity of chemoradiotherapy and improve chemotherapy delivery in phase I and II trials (Mell LK, Sirák I, Wei L, et al. Bone Marrow-sparing IMRT With Concurrent Cisplatin For Stage IB-IVA Cervical Cancer: An International Multicenter Phase II Clinical Trial (INTERTECC-2). Int J Radiat Oncol Biol Phys 2017;97:536-545. Mell LK, Saenz CC, Yashar CM, et al. Phase I Trial of Bone Marrow Sparing IMRT With Concurrent Cisplatin and Gemcitabine in Stage IB-IVA Cervical Cancer (abstr.) Int J Radiat Oncol Biol Phys 2016; 96: S14.). Methods: INTERTECC-3 is a randomized phase III trial designed to test the effect of IG-BMS-IMRT on progression-free survival (PFS) for women with unresected FIGO stage IB-IVA cervical carcinoma (clinicaltrials.gov #NCT01554397). It presently involves centers in the U.S., Czech Republic, U.K., India, Japan, and China. Women are randomized 3:2 to either (A) IG-BMS-IMRT or (B) standard chemoradiation, with 6 cycles of concurrent cisplatin (40 mg/m2) weekly in both arms. Secondary objectives are to compare overall survival, treatment-related toxicity, disease recurrence, quality of life, chemotherapy delivery, and radiation quality assurance. Planning objectives require maintaining pelvic marrow and active marrow mean doses < 27 Gy and < 28.5 Gy respectively. Correlative studies involve longitudinal collection of magnetic resonance restriction spectrum imaging and 18F-fluorothydimine positron emission tomography scans to assess imaging biomarkers of treatment response in select patients. 415 women will be enrolled to determine if IG-BMS-IMRT improves the median PFS from 3.2 to 5.0 years with 80% power and alpha = 0.05. INTERTECC-3 opened in the U.S. and Czech Republic in 2016. To date, 17 patients have been randomized. The trial will be activated at additional international sites in late 2017 and 2018. We are seeking to recruit sites who wish to collaborate. Clinical trial information: NCT01554397.

scholarly journals Feasibility of atlas-based active bone marrow sparing intensity modulated radiation therapy for cervical cancer

2017 ◽  
Vol 123 (2) ◽  
pp. 325-330 ◽  
Author(s):  
Nan Li ◽  
Sonal S. Noticewala ◽  
Casey W. Williamson ◽  
Hanjie Shen ◽  
Igor Sirak ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Bone Marrow ◽  
Radiation Therapy ◽  
Intensity Modulated Radiation Therapy ◽  
Intensity Modulated ◽  
Bone Marrow Sparing

A phase 2 trial of apatinib combined with intensity modulated radiation therapy for patients with unresectable hepatocelluar carcinoma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16136-e16136
Author(s):  
Shaobo Ke ◽  
Hu Qiu ◽  
Jin Peng ◽  
Gaoke Cai ◽  
Yutian Zhangcai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Radiation Therapy ◽  
Performance Status ◽  
Objective Response ◽  
Intensity Modulated Radiation Therapy ◽  
Phase 2 ◽  
Hepatocelluar Carcinoma ◽  
Advanced Hcc ◽  
Intensity Modulated

e16136 Background: To estimate the clinical outcomes and safety for patients with unresectable advanced hepatocelluar carcinoma (HCC) treated with apatinib in combination with intensity modulated radiation therapy (IMRT). Methods: This study was an open-label, single-arm, phase 2 clinical trial of apatinib combined with IMRT for treatment of patients with unresectable advanced HCC. Patients aged between 18 and 75 years with adequate hematologic, liver, and renal functions, and ECOG performance status of 1 or less were included in the study between March 2017 and September 2020. Patients received IMRT (biologically effective dose(BED): 46-60Gy), and continuous apatinib (250-500 mg/d) orally until disease progression or unacceptable toxic effects. The primary end point was progression-free survival(PFS), the secondary end points included overall survival(OS), disease control rate (DCR), objective response rate(ORR) and safety. The data were analyzed for this report with cutoff on February 1, 2021. Results: A total of 46 patients were screened and 33 were enrolled in this study. The cohort had a median age of 56.7 years (range 21-77), 28(84.85%) were men. 25(75.76%) patients had hepatitis B, 32(96.7%) were BCLC stage B-C, 31(93.9%) were Child-Pugh A-B，and 8(24.2%) had portal vein involvement. Receiving first-line and second- or later-line treatment were 21(63.6%) and 12(36.4%), respectively. At a median follow-up of 11.6 months, the median PFS was 7.68 months(95% confidence interval:5.39-9.76) .The 6-month and 12-month overall survival rates were 100% and 96.2%, respectively. According to Response Evaluation Criteria in Solid Tumors Version 1.1, the ORR and DCR were 15% and 82%, respectively. There were 15 (15.2%) grade 3-4 treatment-related adverse events including neutropenia, thrombocytopenia, hypertension, proteinuria and hand and foot syndrome. There were no treatment-related deaths. Conclusions: Apatinib in combination with IMRT was safe and effective in improving PFS and DCR, and suggested an encouraging anti-tumor activity in patients with unresectable advanced HCC. Clinical trial information: ChiCTR-OPC-17011890.

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