NCT02867865Active, not recruitingPhase 2/3
Perioperative Therapy Preoperative Chemotherapy Versus Chemoradiotherapy in Locally Advanced Gall Bladder Cancers
Source: ClinicalTrials.gov · Last updated 13 Mar 2025
Brief summary (registry, in English)
Locally advanced Gall bladders cancers not amenable for curative resection are often treated with chemotherapy alone which is the current standard of care. Randomized trials have shown survival benefit with combination chemotherapy in gallbladder cancers. Gallbladder cancer is not common western world and thus there is lack of evidence regarding the impact of neoadjuvant or concurrent chemo-radiation in this cancer.Use of neoadjuvant treatment with chemotherapy alone or chemoradiotherapy has shown to downsize these tumors to safely undergo R0 resection in few published studies. Also if the patients develop distant metastasis during this neoadjuvant therapy they can be spared of unnecessary surgery. In a pilot study of 28 patients by Engineer et al conducted at Tata Memorial centre treated with neoadjuvant concurrent chemoradiation the investigators could achieve R0 resectability rate 0f 47% with a median overall survival (OAS) and progression free survival (PFS) of 35 and 20 months for the patients undergoing R0 resection. In this study the investigators intend to compare the effects of using neoadjuvant chemotherapy alone vs. neoadjuvant chemoradiation and chemotherapy for locally advanced gall bladder cancers in terms of down staging and overall survival.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 124 (actual)
- First submitted
- 29 Jul 2016
- Start date
- 6 Sept 2016
- Primary completion date
- 10 Sept 2025
- Lead sponsor
- Tata Memorial Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT02867865
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 124
- From 6 Sept 2016 to the primary completion date, 10 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received any prior radiation or chemotherapy.
Other illness
- Resectable disease
Other
- Evidence of distant metastasis (Liver, Lung, peritoneum, port site etc)
- Involving major part of the liver precluding restriction of full RT doses
Who the study is looking for
- Locally advanced T3 or T4 tumors with one or more of the following:
- -\> 2 cm but \< 5 cm liver invasion
- Radiological involvement of antropyloric region of stomach, duodenum, hepatic flexure of colon or small intestine, but without infiltration of the mucosa on endoscopy.
- Type I/II invasion -Involvement of bile duct (common hepatic duct or proximal 1/3 of the common bile duct) causing obstructive jaundice
- Radiological suspicion of lymph node involvement N1 {stations 8, 12, 13) Hepatic artery (Station 8), hepatoduodenal ligament (Station 12), retropancreatic/retroduodenal (Station 13) i.e. size\>1cm in short axis, round in shape, and heterogenous enhancement on PET scan.
- Vascular involvement : impingement/ involvement (\<180 degree angle) of one or more of the following blood vessels common hepatic artery/ right hepatic artery/main portal vein/right portal vein (stage III disease)
- Patient who have undergone prior cholecystectomy having residual disease with at least one of the above features.
- Biopsy/ cytology proven adenocarcinoma
- More than 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Normal hematological and renal and hepatic functions (serum bilirubin \< 3mg/dl)
Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tata Memorial Centre Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.