Clinical Trial: S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)

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 Summary:

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.


Sponsor: Southwest Oncology Group

Current Primary Outcome: Stratum-specific (R0 and R1) 2-year Overall Survival [ Time Frame: 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.


Original Primary Outcome: Stratum-specific (R0 vs R1) and overall 2-year survival

Current Secondary Outcome:

  • Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Stratum-specific Local Relapse Rate [ Time Frame: 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 [ Time Frame: 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).


Original Secondary Outcome:

  • Overall and stratum-specific disease-free survival
  • Survival by anatomic subsite
  • Frequency and severity of toxicity as measured by CTCAE v3.0


Information By: Southwest Oncology Group

Dates:
Date Received: November 12, 2008
Date Started: December 2008
Date Completion: December 2017
Last Updated: October 4, 2016
Last Verified: October 2016