Phase 2 N=97 Randomized Treatment

Combination Chemotherapy and Radiation Therapy With/Without Surgery In Patients With Stage II/III Bladder Cancer

Bladder Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00055601 ↗

Enrolled (actual)

Serious AEs

88.2%

Results posted

Aug 2016

Primary outcome: Primary: Treatment Completion Rate — 67; 53 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: cisplatin (Drug); fluorouracil (Drug); paclitaxel (Drug); radiation therapy (Radiation); Gemcitabine (Drug); Radical cystectomy (Procedure)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Radiation Therapy Oncology Group
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Completion Rate	67; 53	—
SECONDARY Complete Response After Induction	72; 62	—
SECONDARY Bladder-intact Survival Rate (5 Years)	67; 71	—

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of combination chemotherapy plus radiation therapy with or without surgery is more effective in treating bladder cancer. PURPOSE: Randomized phase II trial to study the effectiveness of two combination chemotherapy regimens and radiation therapy with or without radical cystectomy in treating patients who have stage II or stage III bladder cancer.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed operable primary muscle invasive bladder cancer
T2-T4a, NX or N0, M0 (stage II or III)
Must have an adequate functioning bladder
Must have undergone a prior transurethral resection of the bladder tumor within the past 8 weeks
No evidence of tumor-related hydronephrosis
No evidence of distant metastases or histologically or cytologically confirmed lymph node metastases
Patients with involvement of the prostatic urethra with transitional cell cancer that was visibly completely resected are allowed
No evidence of stromal invasion of the prostate

PATIENT CHARACTERISTICS:

Age

Not specified

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Hemoglobin at least 10 g/dL
White blood cell (WBC) count at least 4,000/mm^3
Absolute neutrophil count at least 1,800/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Serum bilirubin no greater than 2.0 mg/dL

Renal

Serum creatinine no greater than 1.5 mg/dL
Creatinine clearance at least 60 mL/min NOTE: If the creatinine clearance is greater than 60 mL/min, creatinine of no greater than 1.8 mg/dL is allowed at the discretion of the study chair

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other malignancy within the past 5 years except nonmelanoma skin cancer, stage T1a prostate cancer, or carcinoma in situ of the cervix
Must be able to tolerate systemic chemotherapy with pelvic radiotherapy and radical cystectomy

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior systemic chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior pelvic radiotherapy

Surgery

See Disease Characteristics

Other

No concurrent drugs that have potential nephrotoxicity or ototoxicity (e.g., aminoglycosides)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00055601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.