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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in overall survival
Secondary outcome measures
Difference in progression-free survival
Incidence of residual disease
Overall resectability rate
+1 moreTrial 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
~1940
Lymphadenectomy
2021
Completed Phase 2
~1480
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Find a Location
Who is running the clinical trial?
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,736 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,668 Total Patients Enrolled
Shishir K MaithelPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hepatitis B virus load is undetectable with treatment.My kidney function, measured by creatinine levels or clearance, is within the normal range.I am HIV positive, on treatment, and my viral load is undetectable.I have another cancer type, but it won't affect this trial's treatment.My cancer is limited and potentially removable by surgery.You do not have any signs of recent fluid buildup in your abdomen.My cancer has not spread to multiple organs beyond the liver.I am fully active or restricted in physically strenuous activity but can do light work.My gallbladder cancer was found by accident during or after gallbladder removal.I had my gallbladder removed within the last 12 weeks.I had hepatitis C but am cured, or I'm being treated with no detectable virus.My cancer has not spread to distant parts of my body.My scans show no cancer spread to distant lymph nodes.I can understand and am willing to sign the consent form.I don't have cancer spread or inoperable cancer based on recent scans.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.I am using or willing to use effective birth control or abstain from sex during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (surgery, adjuvant therapy)
- Group 2: Arm II (neoadjuvant therapy, surgery, adjuvant therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the standard procedure for Lymphadenectomy?
"Lymphadenectomy, which is the surgical removal of lymph nodes, is most often used to treat neoplasm metastasis. However, it is also a viable option for treating small cell lung cancer (sclc), urinary bladder, and advanced testicular cancer."
Answered by AI
Are there other scientific papers which explore Lymphadenectomy in detail?
"Out of the 1064 active clinical trials studying Lymphadenectomy, 361 are in Phase 3. The majority of these Lymphadenectomy trials are based in Shanghai; however, there are 53176 total locations running trials for Lymphadenectomy."
Answered by AI
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