Clinical Trial: A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma

Brief Summary: This research study is evaluating the use of radiation therapy in combination with chemotherapy as a possible treatment for intrahepatic cholangiocarcinoma, a rare form of gastrointestinal cancer.

Detailed Summary:

This study is to assess the possibility of using radiation therapy to treat intrahepatic cholangiocarcinoma. Radiation therapy is used for many other types of malignancies, but its use for the treatment of this form of gastrointestinal cancer has been limited. This treatment is still being studied as research doctors are trying to find out more about its use in the treatment of your form of gastrointestinal cancer. Short course photon radiation and short course proton beam radiation therapies are FDA (U.S. Food and Drug Administration) approved radiation delivery systems. This study will also test the safety of neoadjuvant chemotherapy versus adjuvant chemotherapy. Neoadjuvant therapy is treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery, is given. Adjuvant therapy is additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back.

The current standard of care for patients with intrahepatic cholangiocarcinoma is to offer surgical resection to all patients who have resectable disease and are able to tolerate a major surgical intervention.

The study interventions involved this trial may include one or more of the following:

  • Chemotherapy (Gemcitabine and Cisplatin)
  • Surgical Resection and Lymphadenectomy
  • Radiation Therapy

Sponsor: Massachusetts General Hospital

Current Primary Outcome: Number of Participants Post Operative/Radiation Therapy Complications [ Time Frame: 90 Days ]

Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol.


Original Primary Outcome: Number of Participants Post Operative/Radiation Therapy Complications [ Time Frame: 90 Days ]

  • ACS-NSQIP categories
  • Common Toxicity Criteria 4.0.


Current Secondary Outcome:

Original Secondary Outcome:

  • Overall Response Rate [ Time Frame: End of 3 cycles (up to 12 weeks) ]
    RECIST criteria
  • Progression Free Survival Rate [ Time Frame: Every 3 weeks for 3 months; then continuing every 3 months until 2 years post treatment; then continuing every 6 months until 5 years post treatment. Follow up imaging is required twice yearly for the first 2 years, then annually to year five ]
    Kaplan-Meier method
  • Overall Survival Rate [ Time Frame: Every 3 weeks for 3 months; then continuing every 3 months until 2 years post treatment; then continuing every 6 months until 5 years post treatment. Follow up imaging is required twice yearly for the first 2 years, then annually to year five ]
    Kaplan-Meier method


Information By: Massachusetts General Hospital

Dates:
Date Received: September 25, 2014
Date Started: October 2014
Date Completion:
Last Updated: April 11, 2016
Last Verified: April 2016