SWOG clinical trial number
S0809
A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)
Closed
Phase
Accrual
100%
Published
Abbreviated Title
Cholangiocarcinoma Ph II capecitabine, gemcitabine, RT
Activated
12/01/2008
Closed
10/01/2012
Participants
Research committees
Gastrointestinal Cancer
Treatment
Gemcitabine hydrochloride
Radiation Therapy
Capecitabine
Eligibility Criteria Expand/Collapse
Must have extrahepatic cholangiocarcinoma (gallbladder or bile duct). Must not have ampullary cancer. Must have at least one of the following: pathological T2-4 disease and/or pathological N1 disease and/or positive margins (any T or N stage). No distant metastatic disease. Positive resected regional lymph nodes are allowed. Must have received potentially curative radical resection with negative (R0) or microscopically positive (R1) margins. Resection must have been performed within 56 days prior to registration. No prior chemo or RT for this disease. No prior upper abdominal RT for any reason. Zubrod 0-1. Specimens must be available to be submitted for path review. Must be able to swallow enteral meds. Must not require feeding tube. Must not have GI symptoms listed in Section 5.12 or uncontrolled intercurrent illnesses listed in Section 5.13. Must not be pregnant or nursing. No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer from which the pateint has been disease-free for five years. Within 28 days prior to registration: ANC > 1,500/mcl; platelets > 100,000/mcl; serum creatinine < 1.5 mg/dl; total bilirubin < 1.5 x IULN; SGOT or SGPT < 2.5 x IULN. Within 42 days prior to registration: CT or MRI of chest, abdomen, and pelvis.
Publication Information Expand/Collapse
2023
PMid: PMID36622529 | PMC number: PMC10695673
2021
The effect of radiation modality on outcomes of patients with resected extrahepatic cholangiocarcinoma or gallbladder carcinoma treated with adjuvant capecitabine and gemcitabine followed by radiotherapy and concurrent capecitabine: a secondary analysis of SWOG S0809
2015
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SWOG Clinical Trial Number
CTSU/A022101
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Research Committee(s)
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Activated
01/10/2023
Open
SWOG Clinical Trial Number
S2107
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Research Committee(s)
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Activated
06/06/2022
Accrual
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Open
Phase
SWOG Clinical Trial Number
S2104
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Research Committee(s)
Gastrointestinal Cancer
Activated
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Accrual
27%
Open
Phase