Radiation Therapy in Unresectable Gall Bladder Cancer
ConditionGall Bladder Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTata Memorial Centre
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Systemic therapy (Gemcitabine plus Cisplatin)
- RT
- Systemic therapy (Gemcitabine plus oxaliplatin)
- Systemic therapy (Gemcitabine plus Cisplatin plus Durvalumab)
- Systemic therapy (Gemcitabine plus cisplatin plus nab-paclitaxel)
Treatment groups
249 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov