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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00777491
First received: October 21, 2008
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Drug: cisplatin
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Rate of distant metastasis at 3 years [ Time Frame: From date of randomization to the date of completion of the 3 year follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment completion rate [ Time Frame: From the date of randomization to the date when patients complete consolidation chemotherapy or have a cyctectome with four cycles of gemcitabine and cisplatin. ] [ Designated as safety issue: No ]
  • Grade 3 or more genitourinary, gastrointestinal, and hematologic toxicities as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 [ Time Frame: Acute toxicities - From treatment start date to the end of treatment. Late adverse events - 180 days from the end of treatment. ] [ Designated as safety issue: Yes ]
  • Complete response of the primary tumor [ Time Frame: Three to four weeks from completion of induction chemotherapy. ] [ Designated as safety issue: No ]
  • Preservation of the native, tumor-free bladder 5 years after completion of study therapy [ Time Frame: Five years from the date of trasurethral surgery. ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: December 2008
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive induction therapy comprising fluorouracil IV, cisplatin IV, and radiotherapy in weeks 1-4. Patients then undergo either radical cystectomy or receive consolidation therapy comprising fluorouracil IV, cisplatin IV, and radiotherapy in weeks 8-10.
Drug: cisplatin
Given IV
Drug: fluorouracil
Given IV
Radiation: radiation therapy
Given once or twice daily
Experimental: Arm II
Patients receive induction therapy comprising gemcitabine hydrochloride IV and radiotherapy in weeks 1-4. Patients then undergo either radical cystectomy or receive consolidation therapy comprising gemcitabine hydrochloride IV and radiotherapy in weeks 8-10.
Drug: gemcitabine hydrochloride
Given IV
Radiation: radiation therapy
Given once or twice daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed primary transitional cell carcinoma (TCC) of the bladder within the past 8 weeks

    • Exhibits histological evidence of muscularis propria invasion
  • Clinical stage T2-T4a, NX or N0, M0 disease

    • TCC involvement of the prostatic urethra allowed provided it was visibly completely resected AND there is no evidence of stromal invasion of the prostate
    • No histologically or cytologically confirmed lymph node metastases

      • Radiologic evidence of lymph node positivity allowed provided the lymph node is further evaluated by lymphadenectomy or percutaneous needle biopsy AND confirmed to be negative
    • No evidence of distant metastases
  • Operable disease

    • Has undergone transurethral resection of the bladder tumor within the past 8 weeks
    • Judged to be a candidate for radical cystectomy
  • Adequately functioning bladder after thorough evaluation by an urologist
  • No tumor-related hydronephrosis

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • White blood cell count (WBC) ≥ 4,000/mm^3
  • Absolute neutrophil count (ANC) ≥ 1,800/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
  • Creatinine clearance ≥ 60 mL/min
  • Serum creatinine ≤ 1.5 mg/dL (serum creatinine ≤ 1.8 mg/dL allowed provided creatinine clearance is > 60 mL/min)
  • Serum bilirubin ≤ 2.0 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to tolerate systemic chemotherapy combined with pelvic radiotherapy and a radical cystectomy as determined by the urologist, radiation oncologist, and medical oncologist
  • No other malignancy within the past 5 years except for nonmelanoma skin cancer, stage T1a prostate cancer, or carcinoma in situ of the cervix
  • No severe, active co-morbidities, including any of the following:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring IV antibiotics
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness that requires hospitalization or precludes study therapy
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
    • AIDS
  • No prior allergic reaction to any of the study drugs

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior pelvic radiotherapy
  • No prior systemic chemotherapy for any cancer
  • No concurrent drugs that have potential nephrotoxicity or ototoxicity (e.g., aminoglycosides)
  • No concurrent intensity-modulated radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777491

Locations
United States, Georgia
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
United States, Indiana
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States, 46805
United States, Maryland
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States, 02721
United States, Michigan
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Canada, Quebec
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: John J. Coen, MD Helen and Harry Gray Cancer Center at Hartford Hospital
Study Chair: Donald S. Kaufman, MD Massachusetts General Hospital
Study Chair: Cheryl T. Lee, MD University of Michigan Cancer Center
Study Chair: Chin-Lee Wu, MD, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00777491     History of Changes
Other Study ID Numbers: RTOG 0712, CDR0000616858
Study First Received: October 21, 2008
Last Updated: April 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage II bladder cancer
stage III bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Cisplatin
Fluorouracil
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014