NCT02256982

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Unresectable Intrahepatic Cholangiocarcinoma
• Resectable Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine
DRUG	Cisplatin
PROCEDURE	Surgery	Surgical Resection and Lymphadenectomy
RADIATION	Radiation	Radiation Therapy

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-10-06
• Last updated: 2016-04-13
• Results posted: 2016-04-13

Locations

1 site across 1 country: United States