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Protocol Details

A Phase II Protocol for Subjects with Stage T1 Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent with Radio-sensitizing Chemotherapy following a Thorough Transurethral Surgical Re-Staging

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)



Cystoscopic Surveillance;
Bladder Cancer;
Radiation Therapy;
Bladder Conservation;

Recruitment Keyword(s)



Bladder Cancer;
Bladder Neoplasms;
Bladder Tumors;
Urothelial Cancer;
Urinary Bladder Cancer

Investigational Drug(s)


Investigational Device(s)



Drug: Cisplatin
Drug: Mitomycin
Drug: 5FU
Radiation: Radiation Therapy

Supporting Site

National Cancer InstituteMassachusetts General HospitalRadiation Therapy Oncology Group


- People with a certain type of Stage T1 bladder cancer that has not responded to standard treatment usually must have their bladder removed. But recent reports in more advanced bladder cancer suggest a more limited surgery, then radiation therapy plus chemotherapy, can destroy this cancer. Most who received this treatment did not need their bladder removed, and kept good bladder function. This approach is experimental for this cancer; researchers do not know its effects or how well it works.


- To learn the effects of transurethral surgery then radiation therapy plus chemotherapy on people with Stage T1 bladder cancer.


- Adults 18 years and older, with bladder cancer that has not responded to standard treatment.


- Participants will be screened with a medical history and physical exam. Before the study, their bladder tumor will be surgically removed through the urethra.

- Participants will have blood tests, bone tests, a bladder exam, and body scans all part of regular cancer treatment.

- Participants will receive radiation treatment once a day, 5 days a week, for about 7 weeks.

- Some will receive chemotherapy drug cisplatin through a tube in their vein, 3 days a week, for three of the radiation weeks.

- Others will receive chemotherapy drug mitomycin in their vein on 1 day. Then they will continuously receive drug 5FU through a pump attached to a tube in their vein, during weeks 1 and 4. They do not have to stay at the clinic for this.

- Within 10 weeks later, participants will answer questions and have a bladder exam, urine tests, and a small piece of the bladder removed and tested. Similar follow-up visits will continue for several years.

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-Operable patients with Stage T1 disease (T1G2 or T1G3) for whom radical cystectomy is being considered as the next conventional step in therapy by standard urologic guidelines

-AJCC Stages T1, NX or N0, M0, only transitional cell histology

-Restaged by a urologist in the participating institution with an aggressive, visibly complete TURBT with muscularis propria in the specimen but with no evidence of its invasion by tumor

-Failed standard treatment with, or is medically ineligible for, intravesical biological therapy or chemotherapy

-No evidence of prostatic stromal invasion by tumor

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Weiss C, Wolze C, Engehausen DG, Ott OJ, Krause FS, Schrott KM, Dunst J, Sauer R, R(SqrRoot)(Delta)del C. Radiochemotherapy after transurethral resection for high-risk T1 bladder cancer: an alternative to intravesical therapy or early cystectomy? J Clin Oncol. 2006 May 20;24(15):2318-24.

Harland SJ, Kynaston H, Grigor K, Wallace DM, Beacock C, Kockelbergh R, Clawson S, Barlow T, Parmar MK, Griffiths GO; National Cancer Research Institute Bladder Clinical Studies Group. A randomized trial of radical radiotherapy for the management of pT1G3 NXM0 transitional cell carcinoma of the bladder. J Urol. 2007 Sep;178(3 Pt 1):807-13; discussion 813. Epub 2007 Jul 16.

Shipley WU, Zietman AL, Kaufman DS, Coen JJ, Sandler HM. Selective bladder preservation by trimodality therapy for patients with muscularis propria-invasive bladder cancer and who are cystectomy candidates--the Massachusetts General Hospital and Radiation Therapy Oncology Group experiences. Semin Radiat Oncol. 2005 Jan;15(1):36-41.

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Principal Investigator

Referral Contact

For more information:

Deborah E. Citrin, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM B2-3532
(240) 760-6206

Deborah E. Citrin, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM B2-3532
(240) 760-6206

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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