NCT06214572 Radiation Therapy in Unresectable Gall Bladder Cancer
| NCT ID | NCT06214572 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Tata Memorial Centre |
| Condition | Gall Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 249 participants |
| Start Date | 2024-03-07 |
| Primary Completion | 2029-07-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 249 participants in total. It began in 2024-03-07 with a primary completion date of 2029-07-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare two treatment regimes, namely, systemic therapy (chemotherapy and/or immunotherapy) alone vs. systemic therapy and radiation therapy in patients with inoperable but localized gallbladder cancer. The main questions it aims to answer are: * Whether adding radiation therapy to systemic therapy improves overall survival? * What are the effects on other endpoints like cancer-free intervals, side effects, and quality of life? Participants will be randomly assigned to one of the two treatment regimes mentioned earlier by a computer-based program. Researchers will compare survival and quality of life outcomes between the two groups.
Eligibility Criteria
Inclusion Criteria: * Histologically proven (biopsy/cytology) adenocarcinoma of gall bladder. Gall bladder neck primaries with hilar block mimicking hilar cholangiocarcinoma will also be included. * Non metastatic at presentation as determined using cross sectional imaging and diagnostic laparoscopy if done as a part of standard work up recommended in the joint clinic. * Locally advanced disease with one or more of the following * Extensive liver infiltration not amenable for surgery but feasible for safe radiation delivery (Liver minus gross tumor volume at least 700cc) * Vascular involvement: encasement (\>180-degree angle) of one of the vessels: Hepatic artery, main portal vein, right or left portal vein * Obstructive jaundice with hilar involvement (type 2 non communicating block and higher blocks as per Bismuth-Corlette classification) * Stable disease or partial response (RECIST 1.1) after initial 3 months of Gemcitabine based chemotherapy * More than 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 fit for chemotherapy * Normal hematological and renal and hepatic functions allowing safe delivery of chemotherapy * Hematological- Hb\> 80 g/L, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L. * Liver functions- bilirubin ≤ 2 x upper limit normal (ULN), AST/ALT ≤ 5 x ULN, alkaline phosphatase ≤ 6 x upper limit normal (ULN) S. albumin ≥ 30 g/L * Renal function- Creatinine ≤ 1.5 ULN, Creatinine clearance \>= 50 mL/min Exclusion Criteria: * Patients with distant metastasis (including nonregional lymph nodes metastasis) will be excluded. * Prior abdominal therapeutic radiation * Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix * Pregnancy/Lactating women
Contact & Investigator
Shivakumar Gudi, MD
PRINCIPAL INVESTIGATOR
Assistant Professor, Radiation Oncology
Frequently Asked Questions
Who can join the NCT06214572 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gall Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06214572 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06214572 currently recruiting?
Yes, NCT06214572 is actively recruiting participants. Contact the research team at shivakumargudi@gmail.com for enrollment information.
Where is the NCT06214572 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT06214572 clinical trial?
NCT06214572 is sponsored by Tata Memorial Centre. The principal investigator is Shivakumar Gudi, MD at Assistant Professor, Radiation Oncology. The trial plans to enroll 249 participants.
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