A Phase II/III Study Comparing Chemotherapy Before and After Surgery versus After Surgery Alone to Treat Incidental Gallbladder Cancer

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Full Title

Optimal Perioperative Therapy For Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial (EA2197)(CIRB)

Purpose

The purpose of this study is to compare the effect of giving chemotherapy before and after cancer surgery versus giving it after surgery alone (the usual treatment) for patients with stage II-III gallbladder cancer that was found during gallbladder removal surgery (“incidentally”). Patients will be randomly assigned to receive cisplatin and gemcitabine chemotherapy either before or after cancer surgery or only after the surgery. These medications are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage II or III gallbladder cancer discovered incidentally at the time of or following routine cholecystectomy (gallbladder removal surgery) for presumed benign disease within 12 weeks of entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Imane El Dika at 646-888-6826.

Protocol

21-133

Phase

II/III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

Kingham, T. Peter, MD