S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct
- Conditions
- Gallbladder CancerExtrahepatic Bile Duct Cancer
- Interventions
- Radiation: 3-dimensional conformal radiation therapyRadiation: intensity-modulated radiation therapy
- Registration Number
- NCT00789958
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with gemcitabine followed by capecitabine and radiation therapy works in treating patients with cholangiocarcinoma of the gallbladder or bile duct.
- Detailed Description
OBJECTIVES:
* To estimate the stratum-specific (R0 and R1) and overall 2-year survival probabilities of patients with extrahepatic cholangiocarcinoma treated with adjuvant chemotherapy comprising capecitabine and gemcitabine hydrochloride, followed by capecitabine and radiotherapy. (R0 stratum closed as of 12-15-11)
* To estimate the 2-year stratum-specific and overall disease-free survival and local disease-free survival of patients treated with this regimen.
* To assess the frequency and severity of toxicity in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to margin of resection (negative \[R0\] vs microscopically positive \[R1\]). (R0 stratum closed as of 12-15-11)
* Adjuvant chemotherapy: Patients receive oral capecitabine every 12 hours on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Chemoradiotherapy: Beginning in week 13, patients receive oral capecitabine every 12 hours on days 1-7. Patients also undergo concurrent three-dimensional or intensity-modulated radiotherapy on days 1-5. Treatment repeats weekly for 5-6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study therapy patients are followed periodically for up to 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adjuvant Chemo+ Chemoradiotherapy 3-dimensional conformal radiation therapy Adjuvant Chemotherapy * Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle * Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle Chemoradiotherapy -Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions. intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions. Adjuvant Chemo+ Chemoradiotherapy gemcitabine hydrochloride Adjuvant Chemotherapy * Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle * Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle Chemoradiotherapy -Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions. intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions. Adjuvant Chemo+ Chemoradiotherapy intensity-modulated radiation therapy Adjuvant Chemotherapy * Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle * Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle Chemoradiotherapy -Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions. intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions. Adjuvant Chemo+ Chemoradiotherapy capecitabine Adjuvant Chemotherapy * Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle * Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle Chemoradiotherapy -Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions. intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
- Primary Outcome Measures
Name Time Method Stratum-specific (R0 and R1) 2-year Overall Survival Up to 2 years from registration Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
- Secondary Outcome Measures
Name Time Method 2-year Stratum-specific Local Relapse Rate Up to 2 years from registration Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).
2-year Overall Local Relapse Rate Up to 2 years from registration Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Up to 5 years Only adverse events that are possibly, probably or definitely related to study drug are reported.
2-year Overall Survival for All Patients Up to 2 years from registration Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
2-year Stratum-specific Disease-free Survival Up to 2 years from registration Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.
2-year Disease-free Survival in All Patients Up to 2 years from registration Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.
Trial Locations
- Locations (251)
Regional Medical Center
🇺🇸Anniston, Alabama, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Alta Bates Summit Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Peninsula Medical Center
🇺🇸Burlingame, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Kaiser Permanente Medical Center - Los Angeles
🇺🇸Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Sutter Health - Western Division Cancer Research Group
🇺🇸Novato, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
California Pacific Medical Center - California Campus
🇺🇸San Francisco, California, United States
Scroll for more (241 remaining)Regional Medical Center🇺🇸Anniston, Alabama, United States