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
NCORP, Members, Radiation Oncologists, Surgeons, CTSU, Affiliates

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

Adjuvant Chemoradiation in Patients with Lymph Node Positive Biliary Tract Cancers: A Secondary Analysis of SWOG S0809 Trial

S Gholami;S Colby;D Horowitz;K Guthrie;E Ben-Josef;A El-Khoueiry;CD Blanke;P Philip;L Kachnic;S Ahmad;F Rocha Annals of Surgical Oncology Mar;30(3):1354-1363

PMid: PMID36622529 | PMC number: PMC10695673

ASO Visual Abstract: Adjuvant Chemoradiation in Patients with Lymph Node-Positive Biliary Tract Cancers - Secondary Analysis of a Single-Arm Clinical Trial (SWOG 0809).

S Gholami;S Colby;D Horowitz;K Guthrie;A El-Khoueiry;CD Blanke;PA Philip;L Kachnic;S Ahmad;F Rocha Ann Surg Oncol Mar;30(3):1364-1365

PMid: PMID36542251

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

D Horowitz;M Duong;S Gholami;K Guthrie;F Rocha;E Ben-Josef;C Blanke;A El-Khoueiry;P Philip;S Ahmad;L Kachnic American Society for Radiation Oncology (ASTRO) Annual Meeting (October 24-27, 2021), poster

Does Adjuvant Chemoradiation Benefit Patients with Lymph Node Positive Biliary Tract Cancers? : A Secondary Analysis of SWOG S0809

S Gholami;M Duong;D Horowitz;K Guthrie;E Ben-Josef;A El-Khoueiry;CD Blanke;PA Philip;L Kachnic;S Ahmad;F Rocha J Clin Oncol 39, 2021 (suppl 15; abstr 4104) (American Society of Clinical Oncology Annual Meeting 2021, poster session)

2015

SWOG S0809: A phase II intergroup trial of adjuvant capecitabine/gemcitabine followed by radiotherapy and concurrent capecitabine in extrahepatic cholangiocarcinoma and gallbladder carcinoma

E Ben-Josef;K Guthrie;A El-Khoueiry;C Corless;M Zalupski;A Lowy;CR Thomas;SR Alberts;L Dawson;K Micetich;M Thomas;A Siegel;C Blanke Journal of Clinical Oncology Aug 20;33(24):2617-2622

PMid: PMID25964250 | PMC number: PMC4534524

2014

SWOG S0809: A phase II trial of adjuvant capecitabine (cap)/gemcitabine (gem) followed by concurrent capecitabine and radiotherapy in extrahepatic cholangiocarcinoma (EHCC) and gallbladder carcinoma (GBCA)

E Ben-Josef;K Guthrie;AB El-Khoueiry;CL Corless;MM Zalupski;A Lowy;CR Thomas;SR Alberts;LE Dawson;KC Micetich;MB Thomas;A Siegel;CD Blanke Journal of Clinical Oncology 32:5s (suppl; abstr 4030);ASCO Annual Meeting (May 30-June 3, 2014, Chicago, IL), poster highlights session;