Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer

Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumors cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy is more effective for early-stage breast cancer.
  PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of adjuvant chemotherapy plus radiation therapy in treating women who have early-stage breast cancer.

Detailed description: OBJECTIVES:
  -  Compare the effects of synchronous vs sequential adjuvant chemotherapy and radiotherapy on local recurrence, disease-free and overall survival, and treatment delay in women with early-stage breast cancer.
  -  Compare the safety of these regimens, in terms of dose intensity and toxicity, in this patient population.
  -  Compare the quality of life and cosmetic outcome in patients treated with these regimens.
  OUTLINE: This is a randomized, multicenter study. Patients are stratified according to clinical oncologist, axillary clearance (yes vs no), radiotherapy boost intent (boost vs no boost), and chemotherapy intent (cyclophosphamide, methotrexate, and fluorouracil [5-FU] vs anthracycline-containing regimen). Patients are randomized to one of two treatment arms.
  Patients receive any chemotherapy regimen that includes cyclophosphamide, methotrexate, and 5-FU. Some regimens may also include epirubicin, doxorubicin, mitoxantrone, and/or mitomycin. Chemotherapy repeats every 3 weeks for 4-8 courses.
  -  Arm I (synchronous chemoradiotherapy): Patients receiving synchronous therapy receive any of the above chemotherapy regimens plus daily radiotherapy between courses 2 and 3 OR courses 5 and 6 of chemotherapy. Radiotherapy is administered for 3-5 weeks.
  -  Arm II (sequential chemoradiotherapy): Patients receiving sequential therapy receive any of the above chemotherapy regimens followed by daily radiotherapy beginning after completion of all chemotherapy (after course 6 or 8). Radiotherapy is administered for 3-5 weeks.
  Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.
  Quality of life is assessed before chemotherapy, 2-3 weeks after the completion of all treatment, and then at 1, 2, and 5 years.
  Patients are followed annually for 10 years.
  Peer Reviewed and Funded or Endorsed by Cancer Research UK
  PROJECTED ACCRUAL: A total of 2,250 patients (1,125 per treatment arm) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed invasive breast cancer
  -  Early-stage disease
  -  No metastatic disease
  -  Complete surgical excision of tumor
  -  Planned use of adjuvant chemotherapy and radiotherapy
  -  If participating in the cosmetic outcome evaluation portion of the study, must have unilateral disease
  -  Hormone receptor status
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Sex:
  -  Female
  Menopausal status:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Bone marrow function adequate
  Hepatic:
  -  Hepatic function adequate
  Renal:
  -  Renal function adequate
  Cardiovascular:
  -  Cardiac function adequate
  Other:
  -  No other prior malignancy except basal cell or squamous cell skin cancer or carcinoma in situ
  -  No other medical or social condition that would preclude study compliance
  -  Fit to receive both adjuvant chemotherapy and radiotherapy (administered either synchronously or sequentially)
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  See Disease Characteristics
  -  No prior chemotherapy
  -  No concurrent epirubicin and doxorubicin as a study combination chemotherapy regimen
  Endocrine therapy:
  -  Prior or concurrent hormonal therapy allowed
  -  No concurrent tamoxifen if treated with methotrexate, mitomycin, and mitoxantrone as a study combination chemotherapy regimen
  Radiotherapy:
  -  See Disease Characteristics
  -  No concurrent internal mammary chain irradiation
  -  No concurrent orthovoltage irradiation to the whole breast
  Surgery:
  -  See Disease Characteristics
  -  Recovered from prior surgery
  Other:
  -  Concurrent participation in another clinical trial allowed

Relevance to patient case: not relevant