A phase III randomised clinical trial of perioperative therapy (neoadjuvant chemotherapy versus chemoradiotherapy) in locally advanced gallbladder cancers (POLCAGB): study protocol
Autor: | Reena Engineer, Shraddha Patkar, Shirley Christabel Lewis, Ashutosh Das Sharma, Nitin Shetty, Vikas Ostwal, Anant Ramaswamy, Supriya Chopra, Archi Agrawal, Prachi Patil, Shaesta Mehta, Mahesh Goel |
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Rok vydání: | 2019 |
Předmět: |
Oncology
Adult medicine.medical_specialty 03 medical and health sciences 0302 clinical medicine Postoperative Complications Quality of life Statistical significance Internal medicine Antineoplastic Combined Chemotherapy Protocols Clinical endpoint Protocol Medicine Humans Gallbladder cancer Neoplasm Staging Randomized Controlled Trials as Topic clinical trials business.industry radiation oncology General Medicine Perioperative Chemoradiotherapy medicine.disease Gemcitabine Neoadjuvant Therapy Clinical trial Clinical Trials Phase III as Topic gastrointestinal tumours Chemotherapy Adjuvant Research Design 030220 oncology & carcinogenesis Quality of Life 030211 gastroenterology & hepatology Gallbladder Neoplasms business medicine.drug |
Zdroj: | BMJ Open |
ISSN: | 2044-6055 |
Popis: | IntroductionNeoadjuvant chemotherapy (NACT) is considered the current standard for locally advanced gallbladder cancer (GBC). There is no consensus on the optimal neoadjuvant approach. A pilot study from our institution has shown improved overall survival (OS) and progression-free survival (PFS) with neoadjuvant chemoradiation (NACRT). The present randomised phase III trial is designed to compare NACRT with NACT alone and will test the superiority of chemoradiation in terms of tumour downstaging and improvement in OS.Methods and analysisPatients with biopsy-proven locally advanced GBC (T3–4) with predefined clinical–radiological features will be randomised to the gemcitabine-based chemotherapy-alone arm or the chemoradiation arm. Patients with resectable disease or with distant metastases will be excluded. The primary end point of the study is to compare OS between the two arms. The secondary end point was to compare PFS, R0 resection rates, acute and late toxicity, postoperative complications and quality of life between the two study arms. The trial is designed to detect an improvement in median OS by 5.5 months in the study arm (11 months in the control group, HR of 0.7) with 80.0% power at a 0.05 significance level. The resultant sample size to achieve this aim is 314 (157 in each arm) over a duration of 5 years with a 10% attrition rate.Ethics and disseminationThe institutional ethics committee has approved this trial and will be routinely monitoring the trial at frequent intervals. The results of the study will be disseminated via peer-reviewed scientific journals, conference presentations and submission to regulatory authorities.RegistrationThe trial is registered with Clinical Trials Registry India (CTRI/2016/08/007199) and ClinicalTrials.gov (NCT02867865). This trial aims to assess the superiority of NACRT over NACT in locally advanced GBCs in terms of improvement in OS. The results of this study will define the optimal neoadjuvant approach in locally advanced GBC.Trial registration numberNCT02867865; Pre-results. |
Databáze: | OpenAIRE |
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