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RTOG 0233 Bladder Preservation
A Phase II Randomized Trial for Patients with Muscle-Invading Bladder
Cancer Evaluating Transurethral Surgery and BID Irradiation Plus Either
Paclitaxel and Cisplatin or 5-Fluorouracil and Cisplatin Followed by
Selective Bladder Preservation and Gemcitabine/Paclitaxel/Cisplatin
Adjuvant Chemo.
General Information
Purpose
| | This study is for persons with bladder cancer that invades muscle
and who could potentially undergo surgery with removal of the
bladder (Cystectomy). The goal of the study is to determine if
Transurethral Resection of the Bladder (TURB) followed by two
different chemotherapy regimens combined with radiation can prevent
the need for a Cystectomy thereby preserving the bladder. This study
is also evaluating which of the two chemotherapy regimens is most
effective and the side effects of both treatments. | Protocol Number
| | RTOG 0233 | Eligibility Criteria
| - Biopsy proven bladder cancer with evidence of invasion into
muscle.
- Stage T2 - 4a without hydronephrosis.
- Lymph nodes must be negative by CT or if positive by CT negative
by biopsy.
- There must be no spread to other parts of the body.
- Patients must have a functioning bladder.
- Treatment must begin within 8 weeks of TURB.
- No concurrent or prior malignancies unless disease free for 5
years (non-melanoma skin cancer, Stage T1a prostate or carcinoma
in-situ of the uterine cervix is OK).
- No previous chemotherapy or pelvic radiation therapy.
| Treatment Plan
| Participants will be assigned by chance to one of the following
treatments:
Chemotherapy consisting of Taxol and Cisplatin
given during radiation. The Chemotherapy will be given intravenously
for the first 3 days of each week of radiation therapy. Radiation
therapy will be given initially for a total of 13 treatments (over 3
weeks), Monday through Friday. After this treatment is complete, a
cystoscopy of the bladder and biopsies will be done to determine if
the tumor has responded to treatment. If the cancer has responded an
additional 8 radiation treatments (over 2 weeks) will be given along
with chemotherapy (Taxol and Cisplatin) during the first 3 days of
each week. If there is still cancer in the bladder, removal of the
bladder will be recommended.
OR
Chemotherapy
consisting of 5-FU and Cisplatin given during radiation. The
Chemotherapy will be given intravenously for the first 3 days of
each week of radiation therapy. Radiation therapy will be given
initially for a total of 13 treatments (over 3 weeks), Monday
through Friday. After this treatment is complete, a cystoscopy of
the bladder and biopsies will be done to determine if the tumor has
responded to treatment. If the cancer has responded an additional 8
radiation treatments (over 2 weeks) will be given along with
chemotherapy (5-FU and Cisplatin) during the first 3 days of each
week. If there is still cancer in the bladder, removal of the
bladder will be recommended.
All patients will receive
additional chemotherapy (4 courses) consisting of Gemzar, Taxol and
Cistplatin after their initial treatment is complete (either surgery
or radiation and chemotherapy alone). | Contact Information
| | For additional information regarding this study, contact the
Clinical Research Associates at Radiological Associates, Radiation
Oncology Center, Sacramento (916) 454-6699 X80382 or 80383. | Date Updated
| | 05/19/2006 |
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