AzTrials
AzTrials

Bladder CancerPhase 1/2NCT00003930

Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer

A Phase 1/2 study testing cisplatin, gemcitabine hydrochloride and paclitaxel in people with Bladder Cancer, run by Radiation Therapy Oncology Group at 229 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy and surgery may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
cisplatin, gemcitabine hydrochloride and paclitaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
229 sitesin 2 countries
Study dates
Sep 1999to Nov 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage II or III (T2-4a, Nx or N0, M0) primary carcinoma of the bladder with muscle invasion
  • Resectable disease
  • Prostatic urethral involvement with transitional cell carcinoma allowed, if completely resected and no evidence of stromal invasion
  • No tumor-related hydronephrosis
  • Positive lymph node must be evaluated by lymphadenectomy or percutaneous needle biopsy
  • No nodal metastases
  • No distant metastases
  • No more than 6 weeks since prior transurethral resection of the bladder tumor
  • Functioning bladder

PATIENT CHARACTERISTICS:

Age:

  • Adult

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min

Other:

  • No other prior or concurrent malignancy within the past 5 years except curatively treated nonmelanoma skin cancer, stage I prostate cancer, or carcinoma in situ of the cervix
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Medically operable

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 potential nephrotoxic or ototoxic drugs (e.g., aminoglycosides)

Trial locations and contacts

229 sites in 2 countries.

229 sites in 2 countries

United States210 sites

  • Akron General Medical Center

    Akron, Ohio, 44302

  • Akron City Hospital

    Akron, Ohio, 44309

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • Radiation Oncology Associates of Albuquerque

    Albuquerque, New Mexico, 87109

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • St. John's Medical Center

    Anderson, Indiana, 46016

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0752

  • Anne Arundel Oncology Center

    Annapolis, Maryland, 21401

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Greater Baltimore Medical Center and Cancer Center

    Baltimore, Maryland, 21204

  • Harbor Hospital Center

    Baltimore, Maryland, 21225

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21225

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • St. Luke's Hospital Regional Cancer Center

    Bethlehem, Pennsylvania, 18015

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Bloomington Hospital

    Bloomington, Indiana, 47402

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York, 11203

  • New York Methodist Hospital

    Brooklyn, New York, 11215-3609

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • Cooper Cancer Institute

    Camden, New Jersey, 08103

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio, 45267-0502

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Finger Lakes Radiation Oncology Center

    Clifton Springs, New York, 14432

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • Medical Center/John B. Amos Community Cancer Center

    Columbus, Georgia, 31902

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Mount Diablo Medical Center

    Concord, California, 94524-4110

  • Northeast Medical Center

    Concord, North Carolina, 28025

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Fitzgerald Mercy Hospital

    Darby, Pennsylvania, 19023

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Cancer Center and Beckman Research Institute, City of Hope

    Duarte, California, 91010-3000

  • Wendt Regional Cancer Center of Finley Hospital

    Dubuque, Iowa, 52001

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • Pocono Cancer Center

    East Stroudsburg, Pennsylvania, 18301

  • John F. Kennedy Medical Center

    Edison, New Jersey, 08818

  • Trinitas Hospital - Jersey Street Campus

    Elizabeth, New Jersey, 07201

  • McLaren Regional Cancer Center

    Flint, Michigan, 48432

  • Hurley Medical Center

    Flint, Michigan, 48503

  • California Cancer Center

    Fresno, California, 93720

  • Saint Agnes Cancer Center

    Fresno, California, 93720

  • University of Florida Health Science Center

    Gainesville, Florida, 32610-0296

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0209

  • Saint Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-3508

  • Sutter Health West Cancer Research Group

    Greenbrae, California, 94904

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27858-4354

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • RMH Regional Cancer Center

    Harrisonburg, Virginia, 22801

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Huntsville Hospital System

    Huntsville, Alabama, 35801-4470

  • Comprehensive Cancer Institute of Huntsville

    Huntsville, Alabama, 35801

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • Clarian Health Partners Inc.

    Indianapolis, Indiana, 46206-1367

  • Community Hospitals of Indianapolis - Regional Cancer Center

    Indianapolis, Indiana, 46219

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts, 02130

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • CCOP - Dayton

    Kettering, Ohio, 45429

  • Gundersen Lutheran Medical Foundation

    La Crosse, Wisconsin, 54601

  • Wilford Hall - 59th Medical Wing

    Lackland Air Force Base, Texas, 78236-5300

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756-0002

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California, 90822

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Louisville Radiation Oncology

    Louisville, Kentucky, 40215

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • Southern Wisconsin Radiotherapy Center

    Madison, Wisconsin, 53713

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Merle M. Mahr Cancer Center

    Madisonville, Kentucky, 42431

  • Elliot Regional Cancer Center

    Manchester, New Hampshire, 03103

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Marquette General Hospital

    Marquette, Michigan, 49855

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Health First Holmes Regional Medical Center

    Melbourne, Florida, 32901

  • University of Tennessee, Memphis Cancer Center

    Memphis, Tennessee, 38103

  • Community Memorial Hospital

    Menomonee Falls, Wisconsin, 53051

  • Veterans Affairs Medical Center - Miami

    Miami, Florida, 33125

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • Baptist Hospital of Miami

    Miami, Florida, 33176-2197

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • MidMichigan Medical Center - Midland

    Midland, Michigan, 48670

  • South Jersey Regional Cancer Center

    Millville, New Jersey, 08332

  • Columbia Hospital

    Milwaukee, Wisconsin, 53211

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Trinity Cancer Care Center

    Minot, North Dakota, 58701

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36688

  • Alabama Oncology, LLC

    Montgomery, Alabama, 36106-2801

  • Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

    Mount Holly, New Jersey, 08060

  • Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • St. Anthony Hospital

    Oklahoma City, Oklahoma, 73101

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73190

  • Methodist Cancer Center - Omaha

    Omaha, Nebraska, 68114

  • Nebraska Health System

    Omaha, Nebraska, 68198-7460

  • Florida Radiation Oncology Group

    Orange Park, Florida, 32073

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Bay Medical Center

    Panama City, Florida, 32401

  • Gulf Coast Cancer Treatment Center

    Panama City, Florida, 32405-4587

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068

  • Huntington Cancer Center

    Pasadena, California, 91105

  • Bayshore Medical Center

    Pasadena, Texas, 77504

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104-4283

  • Veterans Affairs Medical Center - Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • Foundation for Cancer Research and Education

    Phoenix, Arizona, 85013

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213-3489

  • Mercy Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15219

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Champlain Valley Physicians Hospital Medical Center

    Plattsburgh, New York, 12901

  • Cancer Care Center

    Pomona, California, 91767

  • Atlantic City Medical Center

    Pomona, New Jersey, 08240

  • Maine Medical Center

    Portland, Maine, 04102

  • CCOP - Columbia River Program

    Portland, Oregon, 97213

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Vassar Brothers Hospital

    Poughkeepsie, New York, 12601

  • Roger Williams Medical Center/BUSM

    Providence, Rhode Island, 02908-4735

  • Southeastern Wisconsin Regional Cancer Center

    Racine, Wisconsin, 53405

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57709

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Bon-Secours - St. Mary's Hospital

    Richmond, Virginia, 23226

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • Regional Radiation Oncology Center at Rome

    Rome, Georgia, 30165

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Radiation Oncology Center - Sacramento

    Sacramento, California, 95816

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132

  • Latter Day Saints Hospital

    Salt Lake City, Utah, 84143

  • Radiation Medical Group, Inc.

    San Diego, California, 92101-1492

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94143-0128

  • O'Connor Hospital

    San Jose, California, 95128

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • Sarasota Radiation and Medical Oncology Center

    Sarasota, Florida, 34233

  • Mercy Hospital Cancer Center - Scranton

    Scranton, Pennsylvania, 18501

  • Virginia Mason Medical Center

    Seattle, Washington, 98111

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Deaconess Medical Center

    Spokane, Washington, 99210-0248

  • Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • Mallinckrodt Institute of Radiology

    St Louis, Missouri, 63108

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63110-0250

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13217

  • Tallahassee Memorial Healthcare

    Tallahassee, Florida, 32308

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • Community Medical Center

    Toms River, New Jersey, 08755

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • St. Francis Medical Center

    Trenton, New Jersey, 08629

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48098

  • St. John Health System

    Tulsa, Oklahoma, 74104

  • Radiation Oncology Associates of West Alabama

    Tuscaloosa, Alabama, 35401

  • Associated Radiologists, P.A.

    Warren Township, New Jersey, 07059

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Schiffler Cancer Center

    Wheeling, West Virginia, 26003

  • Wilkes Barre General Hospital

    Wilkes-Barre, Pennsylvania, 18764

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

  • Riverhill Radiation Oncology

    Yonkers, New York, 10701

  • York Hospital

    York, Pennsylvania, 17315

Other trials in United States

Canada19 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L-4M1

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Northwestern Ontario Regional Cancer Centre, Thunder Bay

    Thunder Bay, Ontario, P7A 7T1

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase I/II Trial in Patients With Muscle-Invading Bladder Cancer of Transurethral Surgery Plus Taxol, Cisplatin and Bid Irradiation Followed by Either Selective Bladder Preservation or Radical Cystectomy and Adjuvant Chemotherapy

RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy and surgery may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer that can be removed by surgery.

Read the detailed description

OBJECTIVES:

  • Evaluate the safety and tolerability of induction chemoradiotherapy with paclitaxel and cisplatin followed by selective bladder preservation or radical cystectomy and adjuvant chemotherapy in patients with stage II or III muscle invasive carcinoma of the bladder previously treated with transurethral tumor resection.
  • Evaluate the efficacy of transurethral tumor resection and induction chemoradiotherapy in achieving a complete response in this patient population.
  • Assess the value of tumor parameters as prognostic factors for initial tumor response and recurrence-free survival in this patient population.

OUTLINE: Four to six weeks after prior transurethral resection, patients receive induction therapy comprising paclitaxel IV over 1 hour on days 1, 8, and 15, cisplatin IV over 1 hour on days 1, 2, 8, 9, 15, and 16, and radiotherapy twice daily on days 1-5, 8-12, and 17.

Four weeks after induction therapy, patients undergo urologic evaluation. At 1-2 weeks after evaluation, patients with complete response receive consolidation therapy comprising paclitaxel IV over 1 hour on days 1 and 8, cisplatin IV over 1 hour on days 1, 2, 8, and 9, and radiotherapy twice daily on days 1-5 and 8-10. Patients with poor tumor response undergo a cystectomy.

At 12 weeks postconsolidation therapy or 8 weeks post radical cystectomy, patients receive adjuvant chemotherapy comprising gemcitabine IV over 30-60 minutes followed by cisplatin IV over 1 hour every 3 weeks. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 3 years.

Conditions
Bladder Cancer
Keywords
stage II bladder cancer, stage III bladder cancer
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00003930
Study groupRoleWhat they receive
Arm 1ExperimentalTransurethral surgery with chemotherapy and radiation therapy followed by either selective bladder preservation or radical cystectomy followed by adjuvant chemotherapy.
Receives: Drug: cisplatin; Drug: gemcitabine hydrochloride; Drug: paclitaxel; Procedure: conventional surgery; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Completion and safety of induction chemo-radiotherapy followed by definitive local therapy of either radical cystectomy or consolidation TCI, followed by four cycles of outpatient adjuvant gemcitabine-cisplatin chemotherapy.

    Completion and safety of induction chemo-radiotherapy (cisplatin, paclitaxel and irradiation [TCI]) followed by definitive local therapy of either radical cystectomy (for patients for whom the initial tumor is not a complete response) or consolidation TCI (for patients for whom the initial tumor has cleared), followed by four cycles of outpatient adjuvant gemcitabine-cisplatin chemotherapy.

    Measured: From start to end of all protocol therapy

Secondary outcomes (5)

  1. Complete response after TCI induction

    Measured: From start to end of all protocol therapy

  2. Completion and safety of the four cycles of gemcitabine-cisplatin chemotherapy

    Measured: From start to end of all protocol therapy

  3. Invasive local treatment failure

    Measured: From start of protocol treatment to date of local failure. Analysis occurs after all patients have copmleted treatment.

  4. Distant metastasis

    Measured: From start of protocol treatment to date of distant metastasis

  5. To examine the value of tumor histopathology, molecular genetics and DNA flow cytometric parameters as possible significant prognostic factors for initial tumor response and recurrence-free survival.

    Measured: From the start of protocol treatment to the date the last patient has completed treatment. Analysis occurs after all patients have completed treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2003 (estimated)
  2. Study startSep 1999
  3. Primary completionJul 2003
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003930
Sponsor's protocol ID
RTOG-9906
Other IDs
CDR0000067122
Status last verified
Oct 2015
First submitted
1 Nov 1999
Last updated
20 Oct 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Efstathiou JA, Bae K, Shipley WU, Kaufman DS, Hagan MP, Heney NM, Sandler HM. Late pelvic toxicity after bladder-sparing therapy in patients with invasive bladder cancer: RTOG 89-03, 95-06, 97-06, 99-06. J Clin Oncol. 2009 Sep 1;27(25):4055-61. doi: 10.1200/JCO.2008.19.5776. Epub 2009 Jul 27.

    PubMed 19636019

  • Kaufman DS, Winter KA, Shipley WU, Heney NM, Wallace HJ 3rd, Toonkel LM, Zietman AL, Tanguay S, Sandler HM. Phase I-II RTOG study (99-06) of patients with muscle-invasive bladder cancer undergoing transurethral surgery, paclitaxel, cisplatin, and twice-daily radiotherapy followed by selective bladder preservation or radical cystectomy and adjuvant chemotherapy. Urology. 2009 Apr;73(4):833-7. doi: 10.1016/j.urology.2008.09.036. Epub 2008 Dec 18.

    PubMed 19100600

  • Kaufman DS, Winter KA, Shipley WU, et al.: Muscle-invading bladder cancer, RTOG Protocol 99-06: initial report of a phase I/II trial of selective bladder-conservation employing TURBT, accelerated irradiation sensitized with cisplatin and paclitaxel followed by adjuvant cisplatin and gemcitabine chemotherapy. [Abstract] J Clin Oncol 23 (Suppl 16): A-4506, 379s, 2005.

  • Mak RH, Hunt D, Shipley WU, Efstathiou JA, Tester WJ, Hagan MP, Kaufman DS, Heney NM, Zietman AL. Long-term outcomes in patients with muscle-invasive bladder cancer after selective bladder-preserving combined-modality therapy: a pooled analysis of Radiation Therapy Oncology Group protocols 8802, 8903, 9506, 9706, 9906, and 0233. J Clin Oncol. 2014 Dec 1;32(34):3801-9. doi: 10.1200/JCO.2014.57.5548. Epub 2014 Nov 3.

    PubMed 25366678

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing cisplatin, gemcitabine hydrochloride and paclitaxel in people with Bladder Cancer, run by Radiation Therapy Oncology Group at 229 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 229 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion and safety of induction chemo-radiotherapy followed by definitive local therapy of either radical cystectomy or consolidation TCI, followed by four cycles of outpatient adjuvant gemcitabine-cisplatin chemotherapy. (time frame: From start to end of all protocol therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003930, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.

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