Clinical trial NCT02256982
Conditions: Unresectable Intrahepatic Cholangiocarcinoma Resectable Intrahepatic Cholangiocarcinoma
Keywords: unresectable intrahepatic cholangiocarcinoma resectable intrahepatic cholangiocarcinoma
Sponsor: Massachusetts General Hospital
Start date: 2014-10-01; Completion date: 2016-03-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

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 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

Arms: arm 1: * Consent and Registration
* 3 cycles of gemcitabine + cisplatin
* Evaluate for surgery\* (weeks 10-15)

  \-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.
* Proceed to surgery
* Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist arm 2: * Consent and Registration
* 3 cycles of gemcitabine + cisplatin
* Evaluate for surgery\* (weeks 10-15)
* Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.
* Proceed to radiation therapy with protons or photons, determined by available resources
* Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist
Interventions: intervention 1: Gemcitabine intervention 2: Cisplatin intervention 3: Surgery intervention 4: Radiation
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Surgical Resection and Lymphadenectomy intervention 4: Radiation Therapy

Protocol documents: