Clinical trial · Interventional
A Randomised Study of Consolidation CTRT Versus Observation After First Line Chemotherapy in Advanced Gallbladder Cancer
A Randomised Study of Consolidation CTRT Versus Observation After First Line Chemotherapy in Advanced Gallbladder Cancer: RACE-GB Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This will be a phase III randomized trial of advanced gall bladder cancers. 140 patients will be randomized. Randomisation will be on a 1:1 ratio between the experimental arm and the control arm. Observation Arm : 6 cycles of Chemotherapy with Gemcitabine and Cisplatin will be followed by observation Chemotherapy followed by Chemo-radiotherapy Arm (CTRT): 6 cycles of Chemotherapy with Gemcitabine and Cisplatin will be followed by Concurrent Chemo-radiation with capecitabine (experimental arm).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gallbladder Cancer Unresectable | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemoradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Consolidation chemoradiation
- description
- 6 cycles of Chemotherapy with Gemcitabine and Cisplatin will be followed by Concurrent Chemo-radiation with capecitabine
- interventionNames
- Radiation: chemoradiation
- type
- ACTIVE_COMPARATOR
- label
- Observation
- description
- 6 cycles of Chemotherapy with Gemcitabine and Cisplatin will be followed by observation
- interventionNames
- Radiation: chemoradiation
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Rt hepatic artery involvement * Rt Branch of portal vein and main PV involvement * CBD/CHD/primary biliary confluence involvement * Duodenum, pancreas, colon involvement * omental metastases, liver involvement limited to segment 4,5 * Nodes in the hepato-duodenal, peripancreatic, common hepatic artery region, Para or preaortic region * Good performance status * BMI \>15 * Have normal organ and marrow function Exclusion Criteria: * Multiple liver Metastasis as evident on CT scan abdomen . * Presence of ascites * Presence of jaundice (obstructive jaundice) * Poor performance status (KPS\<70)
References
Publications (0)
Data not yet available