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Platinum-based Chemotherapy

Pre- and Post-Surgery Chemotherapy for Gallbladder Cancer

Phase 2 & 3

Recruiting

Led By Shishir K Maithel

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Must not have

No radiographic evidence of tumor invasion into multiple extrahepatic organs (T4 disease)

No radiographic evidence of distant disease (M1 disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding chemotherapy before and after surgery is better than just after surgery for treating gallbladder cancer.

Who is the study for?

This trial is for adults with stage II-III gallbladder cancer who've had a cholecystectomy within the last 12 weeks. They should be in good physical condition (ECOG 0-1), have normal organ function, and no severe concurrent diseases. Pregnant or breastfeeding women can't participate, and those able to conceive must use contraception.

What is being tested?

The study compares adding chemotherapy before and after surgery to just after surgery for treating gallbladder cancer. It tests if pre-surgery chemo using gemcitabine hydrochloride and cisplatin makes tumors smaller, eases surgical removal, prevents recurrence better, and extends life compared to the usual treatment.

What are the potential side effects?

Chemotherapy drugs like gemcitabine hydrochloride and cisplatin may cause side effects including nausea, fatigue, kidney damage, low blood cell counts leading to increased infection risk or bleeding problems. Surgery risks include pain, infection at the incision site, and complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My hepatitis B virus load is undetectable with treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My gallbladder cancer was found by accident during or after gallbladder removal.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has not spread to multiple organs beyond the liver.

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My cancer has not spread to distant parts of my body.

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My scans show no cancer spread to distant lymph nodes.

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I don't have cancer spread or inoperable cancer based on recent scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in overall survival

Secondary study objectives

Difference in progression-free survival

Incidence of residual disease

Overall resectability rate

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (neoadjuvant therapy, surgery, adjuvant therapy)Experimental Treatment4 Interventions

Patients receive gemcitabine IV over 30 minutes and cisplatin over 30 minutes-24 hours on days 1 and 8. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Approximately 4-8 weeks after completion of chemotherapy, patients whose disease has not spread to other places in the body (metastasized), then undergo surgery as in Arm I. Patients with successful surgery then resume treatment with gemcitabine IV and cisplatin IV on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (surgery, adjuvant therapy)Active Control4 Interventions

Within 4 weeks of randomization, patients undergo surgery to remove part of the liver, the lymph nodes around the liver, and possibly the bile ducts. Patients then receive gemcitabine IV over 30 minutes and cisplatin IV over 30 minutes-24 hours on days 1 and 8. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Lymphadenectomy

2021

Completed Phase 2

~1480