Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer

NCT00981656 | Completed Phase 2 Results DMC

• 3 other identifiers: RTOG 0926CDR0000654727NCI-2011-01974
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 13

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, mitomycin C, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well radiation therapy given together with chemotherapy works in treating patients with stage I bladder cancer.

Conditions

Bladder Cancer

Keywords

stage I bladder cancer; transitional cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Free From Radical Cystectomy at 3 Years

  The number of participants who did not undergo a radical cystectomy within three years divided by the number of analyzed participants, presented with the 97.5% lower bound.

  Three years from registration

Secondary Outcomes (11)

• Percentage of Participants Free From Radical Cystectomy at 5 Years

  Five years from registration

• Percent of Participants With Distant Disease Progression at 3 Years

  From registration to three years

• Percent of Participants With Distant Disease Progression at 5 Years

  From registration to five years

• Percentage of Participants With Progression to Tumor Stage T2 or Greater at 3 Years

  From registration to three years

• Percentage of Participants With Progression to Tumor Stage T2 or Greater at 5 Years

  From registration to five years

Study Arms (1)

3DCRT + CT

EXPERIMENTAL

Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).

Drug: cisplatin; Drug: 5-fluorouracil; Drug: Mitomycin; Radiation: Three-Dimensional Conformal Radiation Therapy

Interventions

cisplatin DRUG

60-minute intravenous (IV) infusion of 15 mg/m\^2 on days 1, 2, 3, 15, 16, 17, 29, 30, and 31 of radiation treatment.

3DCRT + CT

5-fluorouracil DRUG

Continuous IV infusion of 500 mg/m\^2/24 hrs for 5 consecutive days during weeks 1 and 4 of radiation treatment.

Also known as: 5FU

3DCRT + CT

Mitomycin DRUG

IV bolus dose of 12 mg/m\^2 on day 1 of radiation treatment.

3DCRT + CT

Three-Dimensional Conformal Radiation Therapy RADIATION

Total dose to the gross bladder volume of 61.2 Gy as 34 daily fractions 5 days/week, for approximately 7 weeks.

Also known as: 3DCRT, 3D CRT

3DCRT + CT

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proven diagnosis of carcinoma of the bladder within 105 days prior to registration.
• Operable patients whose initial tumor is a primary high grade urothelial carcinoma of the bladder exhibiting histologic evidence of invasion into the lamina propria (disease clinical stage T1) or a high grade stage Ta urothelial carcinoma without hydronephrosis; patients who have involvement of the prostatic urethra with urothelial carcinoma and have no evidence of stromal invasion of the prostate remain eligible. If the patient's initial tumor was a high grade stage Ta urothelial carcinoma then his/her recurrent tumor must be a high grade stage T1 urothelial carcinoma to be eligible.

You may not qualify if:

• With the presentations as described in Section 2, the participating urologist judges that the standard next therapy, based on present urologic guidelines for this patient, is radical cystectomy.
• If radiologic evaluation of a lymph node is interpreted as "positive", this must be evaluated further either by lymphadenectomy or by percutaneous needle biopsy. Patients with histologically or cytologically confirmed node metastases will not be eligible.
• Patients must have an adequately functioning bladder as judged by the participating urologist and radiation oncologist and have undergone a re-staging TURBT by the participating urologist that showed (or was present in the outside pathology specimen) a high grade stage Ta or T1 tumor with uninvolved muscularis propria in the specimen and, if on prostatic urethral biopsy mucosal carcinoma is present, there is no evidence on biopsy in the prostatic stroma of tumor invasion.
• Patient must be considered able to tolerate systemic chemotherapy combined with pelvic radiation therapy, and a radical cystectomy (if necessary) by the joint agreement of the participating urologist, radiation oncologist, and medical oncologist.
• Appropriate stage for protocol entry, based upon the following minimum diagnostic workup within 60 days prior to registration:
• History/physical examination including weight, performance data, body surface area
• Zubrod Performance Status ≤ 1
• Age ≥ 18
• Complete blood count (CBC)/differential obtained no more than 30 days prior to registration on study, with adequate bone marrow function defined as follows:
• White blood cell count (WBC) ≥ 4,000/ml
• Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
• Platelets ≥ 100,000 cells/mm3
• Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable.)
• If the patient is to be treated with cisplatin, the serum creatinine should be ≤ 1.5 mg%; serum bilirubin of ≤ 2.0 mg%
• Glomerular filtration rate (GFR) \> 25 ml/min \[For patients receiving cisplatin, GFR ≥ 60 ml/min\]

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (13)

Emory Crawford Long Hospital

Atlanta, Georgia, 30308, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

St. Agnes Hospital Cancer Center

Baltimore, Maryland, 21229, United States

Location

Hudner Oncology Center at Saint Anne's Hospital - Fall River

Fall River, Massachusetts, 02721, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Beth Israel Medical Center - Petrie Division

New York, New York, 10003-3803, United States

Location

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Barberton Citizens Hospital

Barberton, Ohio, 44203, United States

Location

Cancer Care Center, Incorporated

Salem, Ohio, 44460, United States

Location

Cancer Treatment Center

Wooster, Ohio, 44691, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0361, United States

Location

Norris Cotton Cancer Center - North

Saint Johnsbury, Vermont, 05819, United States

Location

Related Publications (1)

• Dahl DM, Rodgers JP, Shipley WU, Michaelson MD, Wu CL, Parker W, Jani AB, Cury FL, Hudes RS, Michalski JM, Hartford AC, Song D, Citrin DE, Karrison TG, Sandler HM, Feng FY, Efstathiou JA. Bladder-Preserving Trimodality Treatment for High-Grade T1 Bladder Cancer: Results From Phase II Protocol NRG Oncology/RTOG 0926. J Clin Oncol. 2024 Dec;42(34):4095-4102. doi: 10.1200/JCO.23.02510. Epub 2024 Sep 3.

  PMID: 39226514 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cisplatin; Fluorouracil; Mitomycin; Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Wendy Seiferheld
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

215-574-3208

Study Officials

• William U. Shipley, MD, FACR

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2009
• First Posted: September 22, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2021
• Study Completion: August 15, 2023
• Last Updated: September 19, 2024
• Results First Posted: April 25, 2022

Record last verified: 2023-08

Locations

US (13)