Consolidative Radiotherapy (CSRT) in Patients With Oligometastatic/Locally Advanced Unresectable Bilary Tract Cancer (BTC)
NCT Number: NCT06502080
Acronym: RADITOP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Biliary Tract Cancer
Interventions: RADIATION: Consolidative radiotherapy|DRUG: Standard-of-care systemic therapy: Gemcitabine + cisplatin/oxaliplatin + Durvalumab/Pembrolizumab/Sintilimab/Toripalimab
Sponsor: Shanghai Zhongshan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 128
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2028-06-30
Locations: Zhongshan Hospital, Shanghai, 200032, China

Summary:
The purpose of this clinical trial is to investigate whether the inclusion of radiotherapy, in addition to standard-of-care systemic therapy, could improve the treatment effectiveness of patients with oligometastatic/locally advanced unresectable biliary tract cancer. The primary question that the trial aims to address is: does the addition of consolidative radiotherapy to standard-of-care systemic therapy for treating oligometastatic/locally advanced unresectable biliary tract cancer, result in a prolonged progression-free survival (PFS)?

Researchers will assess whether radiotherapy can enhance PFS by comparing the survival time of patients with oligometastatic/locally advanced unresectable biliary tract cancer who receive standard-of-care systemic therapy alone versus those who receive standard-of-care systemic therapy along with consolidative radiotherapy.

Participants in this trial will:

Either receive or not receive consolidative radiotherapy following six cycles of standard-of-care systemic therapy.

Primary Outcome Measures: Progression Free Survival, Progression free survival is defined as the duration between the date of randomization to the date of first documented progression or death due to any cause or date of last follow-up, whichever is earlier., Upto 2 years
Secondary Outcome Measures: Overall survival (OS), Overall survival is defined as the duration between the date of randomization to the date of death due to any cause or the date of last follow-up, whichever is earlier., Upto 2 years|Local control rates of treated sites, Local control rate will be defined as the absence of progressive disease at the treated sites., Upto 2 years|New distant metastases, Time to onset of new distant metastases., Upto 2 years|Response rates, To compare response rates between the two arms., From randomization every 3 months upto 2 years|Health Related QOL using the EORTC-QLQ-C30 questionnaire, To evaluate patient reported outcomes between the two arms. EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms., From randomization every 3 months till 2 years|Health Related QOL using the EORTC QLQ-BIL21 questionnaire, To evaluate patient reported outcomes between the two arms. EORTC QLQ-BIL21 (European Organisation for Research and Treatment of Cancer questionnaire for measuring quality of life in patients with cholangiocarcinoma and cancer of the gallbladder), scores range from 0 to 100, where a lower score means a better quality of life., From randomization every 3 months till 2 years|Radiotherapy related toxicity using CTC v5.0 (radiotherapy related acute and late toxicity), At baseline and at subsequent follow up till 2 years., Upto 2 years