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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Systemic therapy (Gemcitabine plus Cisplatin)

    Drug

    Participants will receive one of the following Gemcitabine-based systemic therapy alone: Gemcitabine 1000mg/m2 and Cisplatin 25 mg/m2, each administered on Days 1 and 8 every 3 weeks (q3w) Duration: 3 months (in addition to 3 months previously received)

  • RT

    Radiation

    Participants will receive radiation therapy in addition to systemic therapy Hypofractionated external image guided radiation to a dose of 40-55Gy in 10 sessions (up to 60Gy in 15 sessions) over 2-3 weeks. This is followed by systemic therapy as in the Systemic therapy alone arm.

  • Systemic therapy (Gemcitabine plus oxaliplatin)

    Drug

    Gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 IV infusion on days 1 and 8 q2w. Duration: 3 months

  • Systemic therapy (Gemcitabine plus Cisplatin plus Durvalumab)

    Drug

    Durvalumab 1500 mg via intravenous (IV) infusion q4w, starting on Cycle 1 in combination with cisplatin 25 mg/m2 and gemcitabine 1000 mg/m2 each administered on Days 1 and 8, q3w. Duration 3 months Durvalumab (12 months)

  • Systemic therapy (Gemcitabine plus cisplatin plus nab-paclitaxel)

    Drug

    Gemcitabine 800 mg/m2, cisplatin, 25 mg/m2, and nab-paclitaxel 100 mg/m2, on days 1 and 8, q3w Duration: 3 months

Treatment groups

249 Participants
are divided into 2 treatment groups
Group A: Systemic therapyActive comparator 4 interventions
Group B: RT (Radiation therapy)Active comparator 5 interventions

Trial outcomes

Primary outcomes

1

Median overall survival

Time interval between the date of diagnosis and death due to any case.

Time frame
2 years

Secondary outcomes

1

Progression free survival

Time interval between the date of diagnosis and radiological or histological (whichever earlier) evidence of disease progression or death from any cause

Time frame
2 years
2

Locoregional progression free survival

Time interval between the date of diagnosis and radiological or histological (whichever earlier) evidence of locoregional disease progression or death from any cause

Time frame
2 years
3

Response rate

Response to treatment after completion of 6 months of systemic therapy with or without radiotherapy will be assessed using a PET CT or CECT scan using the RECIST (Ver 1.1) criteria

Time frame
6 months
4

Acute toxicities

RTOG criteria

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tata Memorial Centre

Lead sponsor

Source ClinicalTrials.gov
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