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Comparing chemotherapy before and after surgery to after surgery alone for gallbladder cancer

Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial

Phase2; Phase3 Interventional Eastern Cooperative Oncology Group · NCT04559139

This study is testing if giving chemotherapy before and after surgery can help people with stage II-III gallbladder cancer live longer and have fewer leftover cancer cells compared to just getting chemotherapy after surgery.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment186 (estimated)
Ages18 Years and up
SexAll
SponsorEastern Cooperative Oncology Group Research network
Drugs / interventionschemotherapy
Locations367 sites (Birmingham, Alabama and 366 other locations)
Trial IDNCT04559139 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of administering chemotherapy with gemcitabine and cisplatin before and after surgery compared to the standard approach of chemotherapy only after surgery in patients with stage II-III gallbladder cancer. The study aims to determine if preoperative chemotherapy can improve overall survival and reduce the incidence of residual disease. Patients will be randomized into two groups: one receiving chemotherapy before surgery and the other receiving it only after surgery. The trial will also assess the impact of preoperative chemotherapy on the resectability of tumors and progression-free survival.

Who should consider this trial

Good fit: Ideal candidates include patients with stage II-III gallbladder cancer who have undergone initial cholecystectomy within the last 12 weeks.

Not a fit: Patients with early-stage (Tis, T1a, T1b) or advanced-stage (T4) gallbladder tumors will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates and better management of gallbladder cancer.

How similar studies have performed: Other studies have shown promising results with neoadjuvant chemotherapy approaches in various cancers, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Patient must have histologically-confirmed T2 or T3 gallbladder cancer discovered incidentally at the time of or following routine cholecystectomy for presumed benign disease

  * NOTE: Patients with histologically-confirmed Tis, T1a, T1b, or T4 tumors are not eligible
* Patient must have undergone initial cholecystectomy within 12 weeks prior to randomization
* Patient must have the ability to understand and the willingness to sign a written informed consent document
* Leukocytes \>= 3,000/mcL (obtained =\< 28 days prior to randomization)
* Absolute neutrophil count \>= 1,500/mcL (obtained =\< 28 days prior to randomization)
* Platelets \>= 100,000/mcL (obtained =\< 28 days prior to randomization)
* Total bilirubin =\< institutional upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome are eligible if direct bilirubin \< 1.5 x ULN of the direct bilirubin (obtained =\< 28 days prior to randomization)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained =\< 28 days prior to randomization)
* Serum creatinine =\< institutional ULN OR creatinine clearance \>= 50 mL/min/1.73 m\^2 (Based on Cockcroft Gault estimation) (obtained =\< 28 days prior to randomization)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better

Exclusion Criteria:

* Patient must not have any evidence of metastatic disease or inoperable loco-regional disease based on high-quality, preoperative, cross-sectional imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) of the chest, abdomen, and pelvis (C/A/P) obtained within 6 weeks prior to randomization, defined as

  * No radiographic evidence of distant disease (M1 disease)
  * No radiographic evidence of tumor invasion into multiple extrahepatic organs (T4 disease)
  * No radiographic evidence of distant lymph node involvement (celiac, para-aortic, para-caval lymph nodes)
  * No evidence of new-onset ascites
  * Soft tissue thickening within or in direct communication with the gallbladder fossa, peri-portal lymph node involvement, involvement of one extrahepatic organ, and other disease within the confines of what constitutes 'localized resectable' disease are allowable
* Women must not be pregnant or breast feeding due to the potential harm to unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 14 days prior to randomization. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Women of childbearing potential and sexually active males must not expect to conceive or father children by being strongly advised to use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study

Where this trial is running

Birmingham, Alabama and 366 other locations

+317 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Stage II Gallbladder Cancer AJCC v8Stage IIA Gallbladder Cancer AJCC v8Stage IIB Gallbladder Cancer AJCC v8Stage III Gallbladder Cancer AJCC v8Stage IIIA Gallbladder Cancer AJCC v8Stage IIIB Gallbladder Cancer AJCC v8
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.