Unresectable Intrahepatic Cholangiocarcinoma Clinical Trial
Official title:
A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma
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.
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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