scholarly journals Robot-assisted approach to cervical cancer (RACC): an international multi-center, open-label randomized controlled trial

2019 ◽  
Vol 29 (6) ◽  
pp. 1072-1076 ◽  
Author(s):  
Henrik Falconer ◽  
Kolbrun Palsdottir ◽  
Karin Stalberg ◽  
Pernilla Dahm-Kähler ◽  
Ulrika Ottander ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Randomized Controlled Trial ◽  
Early Stage ◽  
Controlled Trial ◽  
Recurrence Free Survival ◽  
Robot Assisted ◽  
Open Label ◽  
Free Survival ◽  
Randomized Controlled ◽  
Early Stage Cervical Cancer

BackgroundRadical hysterectomy with pelvic lymphadenectomy represents the standard treatment for early-stage cervical cancer. Results from a recent randomized controlled trial demonstrate that minimally invasive surgery is inferior to laparotomy with regards to disease-free and overall survival.Primary ObjectiveTo investigate the oncologic safety of robot-assisted surgery for early-stage cervical cancer as compared with standard laparotomy.Study HypothesisRobot-assisted laparoscopic radical hysterectomy is non-inferior to laparotomy in regards to recurrence-free survival with the advantage of fewer post-operative complications and superior patient-reported outcomes.Trial DesignProspective, multi-institutional, international, open-label randomized clinical trial. Consecutive women with early-stage cervical cancer will be assessed for eligibility and subsequently randomized 1:1 to either robot-assisted laparoscopic surgery or laparotomy. Institutional review board approval will be required from all participating institutions. The trial is coordinated from Karolinska University Hospital, Sweden.Major Inclusion/Exclusion CriteriaWomen over 18 with cervical cancer FIGO (2018) stages IB1, IB2, and IIA1 squamous, adenocarcinoma, or adenosquamous will be included. Women are not eligible if they have evidence of metastatic disease, serious co-morbidity, or a secondary invasive neoplasm in the past 5 years.Primary EndpointRecurrence-free survival at 5 years between women who underwent robot-assisted laparoscopic surgery versus laparotomy for early-stage cervical cancer.Sample SizeThe clinical non-inferiority margin in this study is defined as a 5-year recurrence-free survival not worsened by >7.5%. With an expected recurrence-free survival of 85%, the study needs to observe 127 events with a one-sided level of significance (α) of 5% and a power (1−β) of 80%. With 5 years of recruitment and 3 years of follow-up, the necessary number of events will be reached if the study can recruit a total of 768 patients.Estimated Dates for Completing Accrual and Presenting ResultsTrial launch is estimated to be May 2019 and the trial is estimated to close in May 2027 with presentation of data shortly thereafter.Trial RegistrationThe trial is registered at ClinicalTrials.gov (NCT03719547).

scholarly journals Minimally invasive versus open radical trachelectomy for early-stage cervical cancer: protocol for a multicenter randomized controlled trial in China

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Xiaopei Chao ◽  
Lei Li ◽  
Ming Wu ◽  
Huanwen Wu ◽  
Shuiqing Ma ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Randomized Controlled Trial ◽  
Early Stage ◽  
Controlled Trial ◽  
Disease Free Survival ◽  
Radical Trachelectomy ◽  
Free Survival ◽  
Randomized Controlled ◽  
Early Stage Cervical Cancer ◽  
Disease Free

Abstract Background There are limited data comparing the oncologic and fertility outcomes of patients with early-stage cervical cancer (CC) treated by minimally invasive radical trachelectomy (MIRT) or abdominal radical trachelectomy (ART). The purpose of this multicenter study is to compare the oncologic and fertility outcomes of patients treated by MIRT or ART in a randomized controlled manner in China. Methods This is a noninferiority, randomized controlled trial performed at 28 Chinese centers; the study is designed to compare the oncologic and fertility outcomes of patients treated by MIRT (robot-assisted or laparoscopic RT) or ART. Patients will be recruited if they have been diagnosed with stage IA1 (with lymphovascular space invasion), IA2, or IB1 CC (with a maximum tumor diameter ≤ 2 cm) in the FIGO 2009 staging system and histological subtypes of squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma and if they are also aged 18 to 40 years. These candidates will be randomly assigned to undergo MIRT or ART. The primary endpoint will be disease-free survival. Secondary endpoints will consist of overall and disease-free survival rates, fertility outcomes, and quality of life. A total of 414 patients are needed to accomplish the study goal, with 90.1% power at a 0.050 significance level to detect an equivalence hazard ratio of 0.75 in the ART group, considering 20% loss to follow-up. Discussion The results of the trial should provide robust evidence to surgeons regarding options for the surgical approach in patients with early-stage CC who have a strong willingness to preserve fertility. Trial registration ClinicalTrials.gov NCT03739944. Registered on November 14, 2018

scholarly journals Feasibility of a Fast-track Randomized Controlled Trial of Cell-free and Concentrated Ascites Reinfusion Therapy for Patients with Refractory Malignant Ascites

2021 ◽  
Author(s):  
Naosuke Yokomichi ◽  
Kengo Imai ◽  
Masaki Sakamoto ◽  
Masashi Horiki ◽  
Toshihiro Yamauchi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Fast Track ◽  
Controlled Trial ◽  
Malignant Ascites ◽  
Feasibility Trial ◽  
Advanced Cancer Patients ◽  
Open Label ◽  
Free Survival ◽  
Randomized Controlled ◽  
Study Intervention

Abstract Purpose: Malignant ascites often causes discomfort in advanced cancer patients. Cell-free and concentrated ascites reinfusion therapy (CART) is one treatment modality, but controlled trials are lacking. We assessed the feasibility of a randomized controlled trial of CART vs. paracentesis alone for patients with refractory malignant ascites.Methods: This study was an open-label, fast-track, randomized controlled, feasibility trial. Patients admitted to four designated cancer hospitals who received no further anticancer treatments were eligible. Patients were randomly assigned 1:1 to a CART arm or control (simple paracentesis) arm. The feasibility endpoint was the percentage of patients who completed the study intervention. Secondary endpoints included paracentesis-free survival, patient request on the questionnaire for paracentesis (PRO-paracentesis)-free survival (the period until the patients first reported that they would want a paracentesis if indicated), and adverse events.Results: We screened 953 patients for eligibility. Of 61 patients with refractory malignant ascites, 21 patients were determined as eligible. Finally, 20 patients consented and were allocated; 18 patients (90%, 95% CI: 68.3-98.8) completed the study intervention. Median paracentesis-free survivals were 5 days (95% CI: 2-6) in the CART arm, and 6 days (3-9) in the control arm. Median PRO-paracentesis-free survivals were 4 days (2-5) and 5 days (1-9), respectively. One patient in the CART arm developed Grade 1 fever. Conclusion: A fast-track randomized controlled trial of CART for patients with malignant ascites is feasible. The efficacy and safety of CART should be assessed in future trials. PRO-paracentesis-free survival may be an outcome measure that complements paracentesis-free survival.

NEOADJUVANT CHEMOTHERAPY FOLLOWED BY RADICAL SURGERY VERSUS CHEMORADIATION FOR STAGE IB2, IIA2 AND IIB CERVICAL CANCER: AN OPEN-LABEL, PHASEIII, RANDOMIZED CONTROLLED TRIAL.

2019 ◽  
Author(s):  
Maria Del Pilar Estevez Diz ◽  
Pedro Thome Francisco dos Reis Filho ◽  
Francisco Jose Candido dos Reis ◽  
Mariana de Paiva batista ◽  
Andres Poveda ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Randomized Controlled Trial ◽  
Neoadjuvant Chemotherapy ◽  
Radical Surgery ◽  
Controlled Trial ◽  
Open Label ◽  
Randomized Controlled
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