Clinical Research Details
Title:
A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC).
Purpose:
The purpose of this study is to estimate the stratum-specific (RO and R1) and overall two-year survival probabilities of EHCC participants treated with adjuvant capecitabine/gemcitabine followed by capecitabine and radiotherapy.
Study Number:
201598
Number of Patients:
80
Elgibility:
A histology of EHCC with no ampullary cancer.
Participant must have at least 1 of 3:
-pT2-4
-pN1
-positive margins (any T or N stage)
Per CT/MRI: no metastatic disease within 42 days of registration. Positive, re-seceted lymph nodes are acceptable.
Tumor margins must be negative margins for cancer (R0), with curative intent from the radical resection done, or microscopically positive (R1) margins, performed within 56 days prior to registration.
No prior chemo or radiation for this disease, or upper abdominal radiation for any reason.
Adequate bone marrow, renal and hepatic function within 28 days of registration.
Zubrod performance status of 0-1.
Specimen available for submission.
Able to swallow medication, no feeding tubes accepted.
No GI disturbances of N/V, malabsorption, IBS, etc.
No uncontrolled infections, cardiac dissease (within 3 months to registration) or psychiatric illness/social situtations limiting compliance.
No pregnant woman and if nursing, they must discontinue.
Treatment:
Between 3-8 weeks after your last radiation treatment, you will have surgery to try to remove any cancer that might remain.
Principal Investigator:
Enrollment Phone:
(708) 327-1240