Clinical trial · Interventional
Chemotherapy Before & After Surgery in Patients With Resectable Gallbladder Cancer
Perioperative Chemotherapy Prior To and After Reoperation for Incidental Gallbladder Cancer - An International, Randomized Phase III Trial
NCT03579758CI-TRIAL-00045427withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This trial will open as an NCTN trial.
Summary
Brief summary (as posted)
This phase III trial studies how well chemotherapy before and after surgery works in treating participants with gallbladder cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin, gemcitabine, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery may kill more tumor cells.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage I Gallbladder Cancer AJCC v8 | Malignant Gallbladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Gallbladder Cancer AJCC v8 | Malignant Gallbladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Gallbladder Cancer AJCC v8 | Malignant Gallbladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Gallbladder Cancer AJCC v8 | Malignant Gallbladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Gallbladder Cancer AJCC v8 | Malignant Gallbladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Gallbladder Cancer AJCC v8 | Malignant Gallbladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Gallbladder Cancer AJCC v8 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (capecitabine)
- description
- Participants undergo re-resection (including partial liver resection and portal lymph node dissection). Participants then receive capecitabine PO BID on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- Arm II (chemotherapy, capecitabine)
- description
- Participants receive cisplatin IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Within 10 weeks of chemotherapy, participants undergo re-resection (including partial liver resection and portal lymph node dissection). Participants then receive capecitabine PO BID on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Capecitabine
- Drug: Cisplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-confirmed T1b, T2 or T3 gallbladder cancer discovered incidentally at the time of or following routine cholecystectomy for presumed benign disease * Resectable disease at the time of enrollment based on high-quality, preoperative, cross-sectional imaging of the chest, abdomen, and pelvis (C/A/P) * Enrollment and randomization within 12 weeks of initial cholecystectomy * High-quality cross-sectional imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) performed within 4 weeks prior to enrollment * Able to give informed consent * Able to adhere to study visit schedule and other protocol requirements * Eastern Cooperative Oncology Group (ECOG) performance status of \< 2 * Absolute neutrophil count ≥ 1500/mm³ * Platelet count ≥ 100,000/mm³ Exclusion Criteria: * Patients with histologically-confirmed Tis, T1a, or T4 tumors * Unresectable gallbladder cancer at the time of enrollment based on high-quality, preoperative, cross-sectional imaging of the C/A/P * Unable to sign informed consent * Serum creatinine \> 1.5 x upper limit of normal or estimated creatinine clearance (CrCl) \< 45 ml/min * Serum total bilirubin \> 1.5 x upper limit of normal * Presence of active infection * Pregnant and/or breastfeeding * Known dihydropyrimidine dehydrogenase deficiency
References
Publications (0)
Data not yet available
No reference posted for this study.