Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer That Was Removed by Surgery

Completed · Phase 2

Conditions studied: Bladder Cancer

In brief

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, 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. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different chemotherapy and radiation therapy regimens to see how they work in treating patients with stage II or stage III bladder cancer that was removed by surgery.

Key facts

Study ID

NCT00777491

Run by

Radiation Therapy Oncology Group

People needed

70

Starts

2008-12-01

Expected to finish

2022-05-20

Last updated by the study team

2022-06-15

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically (histologically or cytologically) proven diagnosis of primary carcinoma of the bladder (transitional cell cancer) within 8 weeks of registration. Operable patients whose tumors are primary carcinomas of the bladder and exhibit histologic evidence of muscularis propria invasion and are American Joint Committee on Cancer (AJCC) clinical stages T2-T4a, Nx or N0, M0 (Appendix IV) without hydronephrosis; patients who have involvement of the prostatic urethra with transitional cell cancer (TCC) that was visibly completely resected and no evidence of stromal invasion of the prostate remain eligible. T2a, T2b, T3a, T3b -substages‖ are not usually able to be determined with clinical (TURBT) staging.
• If radiologic evaluation of a lymph node is interpreted as "positive", this must be evaluated further either by lymphadenectomy or percutaneous needle biopsy. Patients with histologically or cytologically confirmed node metastases will not be eligible.
• Patients must have an adequately functioning bladder after thorough evaluation by an urologist and have undergone as thorough a transurethral resection of the bladder tumor as is judged safely possible.
• Patients must be considered able to tolerate systemic chemotherapy combined with pelvic radiation therapy, and a radical cystectomy by the joint agreement of the participating Urologist, Radiation Oncologist, and Medical Oncologist.
• History and physical examination including weight, performance status, and body surface area within 8 weeks prior to study registration
• Zubrod Performance Status ≤ 1
• Age ≥ 18
• Complete blood count (CBC)/differential obtained no more than 4 weeks prior to registration on study, with adequate bone marrow function defined as follows:
• 8.1 White blood cell count (WBC) ≥ 4000/ml
• 8.2 Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3;
• 8.3 Platelets ≥ 100,000 cells/mm3;
• 8.4 Hemoglobin (hgb) ≥ 10.0 mg/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable.);
• Serum creatinine of 1.5 mg% or less; serum bilirubin of 2.0 mg% or less; creatinine clearance of 60 ml/min or greater no more than 4 weeks prior to registration; Note: Calculated creatinine clearance is permissible. If the creatinine clearance is > 60 ml/min, then a serum creatinine of up to 1.8 mg% is allowable at the discretion of the study chair;
• Serum pregnancy test for female patients of childbearing potential, ≤ 72 hours prior to study entry; women of childbearing potential and male participants must practice adequate contraception.
• Patient must be able to provide study-specific informed consent prior to study entry.

You may not qualify if…

• Evidence of tumor-related hydronephrosis
• Evidence of distant metastases or histologically or cytologically proven lymph node metastases
• Previous systemic chemotherapy (for any cancer) or pelvic radiation therapy
• A prior or concurrent malignancy of any other site or histology unless the patient has been disease-free for ≥ 5 years except for non-melanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix
• Patients judged not to be candidates for radical cystectomy; patients with pN+ or T4b disease are considered to have unresectable disease
• Patients receiving any drugs that have potential nephrotoxicity or ototoxicity (such as an aminoglycoside)
• Severe, active co-morbidity, defined as follows:
• 7.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
• 7.2 Transmural myocardial infarction within the last 6 months;
• 7.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
• 7.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
• 7.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
• 7.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
• Prior allergic reaction to the study drug(s) involved in this protocol

Where it is running

• Georgia Cancer Center for Excellence at Grady Memorial Hospital — Atlanta, Georgia, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center — Boise, Idaho, United States
• Cancer Institute at St. John's Hospital — Springfield, Illinois, United States
• Parkview Regional Cancer Center at Parkview Health — Fort Wayne, Indiana, United States
• St. Agnes Hospital Cancer Center — Baltimore, Maryland, United States
• Hudner Oncology Center at Saint Anne's Hospital - Fall River — Fall River, Massachusetts, United States
• Saint Joseph Mercy Cancer Center — Ann Arbor, Michigan, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• McGill Cancer Centre at McGill University — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.