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CompletedNCT00981656Updated Sep 19, 2024Results posted

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

A Phase 2 interventional study of cisplatin and 5-fluorouracil in Bladder Cancer, sponsored by Radiation Therapy Oncology Group. Completed at 13 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Radiation Therapy Oncology Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

Read the detailed description

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and annually thereafter until termination of the study.

02

Conditions studied

  • Bladder Cancer

Keywords

  • stage I bladder cancer
  • transitional cell carcinoma of the bladder
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's enrollment of 37 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Radiation Therapy Oncology Group is the lead sponsor of 154 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. Patients must have a high grade urothelial carcinoma stage Ta or T1 that has recurred within 540 days after completion of the initial treatment [TURBT and intravesical Bacillus Calmette Guerin (BCG) immunotherapy] or on initial presentation with a T1 high grade tumor, the participating urologist judged BCG therapy is contraindicated or unsuitable because the patient is found to be intolerant of BCG therapy or because this patient may be immuno-compromised in ways other than that mentioned in Exclusion Criteria 2.8 or because the patient refuses BCG therapy.
  3. 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.
  4. 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.
  5. 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.
  6. 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.

  7. 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
  8. Zubrod Performance Status ≤ 1
  9. Age ≥ 18

  10. 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.)
  11. If the patient is to be treated with cisplatin, the serum creatinine should be ≤ 1.5 mg%; serum bilirubin of ≤ 2.0 mg%
  12. Glomerular filtration rate (GFR) > 25 ml/min [For patients receiving cisplatin, GFR ≥ 60 ml/min]
  13. Serum pregnancy test for female patients of childbearing potential, ≤ 72 hours prior to study entry; women of childbearing potential and male participants must practice adequate contraception.
  14. Patient must be able to provide study-specific informed consent prior to study entry.

Exclusion criteria

Exclusion Criteria

  1. Evidence of tumor-related hydronephrosis
  2. Evidence of distant metastases or histologically or cytologically proven lymph node metastases
  3. Prior systemic chemotherapy for bladder cancer; prior chemotherapy for a different cancer is allowable
  4. A prior or concurrent malignancy of any other site or histology unless the patient has been disease-free for ≥ 5 years except for non-melanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix or a urothelial carcinoma of the upper urinary tract stage pTa, pTis or pT1 that has not been free of disease after treatment for more than a 2-year period
  5. Patients with pN+ or > T1 disease or who have not had a visibly complete TURBT
  6. Patients receiving any drugs that have potential nephrotoxicity or ototoxicity (such as an aminoglycoside)
  7. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

  8. Severe, active co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
    • Transmural myocardial infarction within the last 6 months;
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
    • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
    • Acquired Immune Deficiency Syndrome (AIDS) based upon the current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
  9. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
  10. Prior allergic reaction to the study drugs (cisplatin, mitomycin, 5FU) involved in this
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    3DCRT + CT

    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

  • Drugcisplatin

    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.

  • Drug5-fluorouracil

    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

  • DrugMitomycin

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

  • RadiationThree-Dimensional Conformal Radiation Therapy

    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

06

What researchers measure

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.

    Time frame: Three years from registration

Secondary outcomes

  1. Percentage of Participants Free From Radical Cystectomy at 5 Years

    The number of participants who did not undergo a radical cystectomy within five years divided by the number of analyzed participants.

    Time frame: Five years from registration

  2. Percent of Participants With Distant Disease Progression at 3 Years

    Distant disease progression is defined as the first appearance of disease in a non-regional lymph node, solid organ or bone. Time to distant disease progression is defined as time from registration to the date of first distant disease progression, last known follow-up (censored), or death without distant disease progression (competing risk). Distant disease progression rate is estimated using the cumulative incidence method.

    Time frame: From registration to three years

  3. Percent of Participants With Distant Disease Progression at 5 Years

    Distant disease progression is defined as the first appearance of disease in a non-regional lymph node, solid organ or bone. Time to distant disease progression is defined as time from registration to the date of first distant disease progression, last known follow-up (censored), or death without distant disease progression (competing risk). Distant disease progression rate is estimated using the cumulative incidence method.

    Time frame: From registration to five years

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

    Primary tumor stage T2 = tumor invades muscle; T3 = tumor invades perivesical tissue; T4 = tumor invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall. Time to progression is defined as time from registration to the date of first progression, last known follow-up (censored), or death without tumor progression (competing risk). Tumor progression rates was to be estimated using the cumulative incidence method.

    Time frame: From registration to three years

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

    Primary tumor stage T2 = tumor invades muscle; T3 = tumor invades perivesical tissue; T4 = tumor invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall. Time to progression is defined as time from registration to the date of first progression, last known follow-up (censored), or death without tumor progression (competing risk). Tumor progression rate was to be estimated using the cumulative incidence method.

    Time frame: From registration to five years

  6. Percentage of Participants Who Have Died From Bladder Cancer at 5 Years (Disease-specific Survival)

    Time to death from bladder cancer is defined as time from registration to death from bladder cancer, last known follow-up (censored), or death from other cause (competing risk). More specifically, death absent a distant metastasis, death from non-bladder cancer, and death absent local recurrence comprise the competing risk. Death from bladder cancer rate is estimated using the cumulative incidence method.

    Time frame: From registration to five years

  7. Percentage of Participants Alive at 3 Years

    Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.

    Time frame: From registration to three years

  8. Percentage of Participants Alive at 5 Years

    Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.

    Time frame: From registration to five years

  9. Distribution of Participants by Highest Grade Adverse Event

    Common Terminology Criteria for Adverse Events (CTCAE) version 4 grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

    Time frame: Adverse events are evaluated 8-10 weeks after end of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for 3 years, then annually. Maximum follow-up at time of reporting was 8.6 years.

  10. Percentage of Participants With Local Recurrence at 3 Years

    Time to local recurrence is defined as time from registration to the date of first local recurrence, last known follow-up (censored), or death without local recurrence (competing risk). Local recurrence rate is estimated using the cumulative incidence method.

    Time frame: From registration to three years

  11. American Urological Association Total Symptom Score at Baseline and at 3 Years

    The American Urological Association Total symptom score measures the severity of enlarged prostate symptoms. Possible scores range from 0 to 35, with higher scores indicating worse symptoms.

    Time frame: Baseline and 3 years

07

Results

Posted Apr 25, 2022

Participant flow

Participant flow — Overall Study
Milestone3DCRT + CT
Started37
Eligible and started study treatment34
Completed34
Not completed3
Withdrew: Protocol violation1
Withdrew: Did not start protocol treatment2

Outcome measures

PrimaryPercentage 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.

Time frame:
Three years from registration
Reported as:
Number · percentage of participants
Percentage of Participants Free From Radical Cystectomy at 3 Years
percentage of participants3DCRT + CT
Percentage of Participants Free From Radical Cystectomy at 3 Years88.2 (72.5 to NA)
Statistical analysis
  • 3DCRT + CT ·
SecondaryPercentage of Participants Free From Radical Cystectomy at 5 Years

The number of participants who did not undergo a radical cystectomy within five years divided by the number of analyzed participants.

Time frame:
Five years from registration
Reported as:
Number · percentage of participants
Percentage of Participants Free From Radical Cystectomy at 5 Years
percentage of participants3DCRT + CT
Percentage of Participants Free From Radical Cystectomy at 5 Years88.2 (72.5 to 96.7)
SecondaryPercent of Participants With Distant Disease Progression at 3 Years

Distant disease progression is defined as the first appearance of disease in a non-regional lymph node, solid organ or bone. Time to distant disease progression is defined as time from registration to the date of first distant disease progression, last known follow-up (censored), or death without distant disease progression (competing risk). Distant disease progression rate is estimated using the cumulative incidence method.

Time frame:
From registration to three years
Reported as:
Number · percentage of participants
Percent of Participants With Distant Disease Progression at 3 Years
percentage of participants3DCRT + CT
Percent of Participants With Distant Disease Progression at 3 Years12.3 (3.8 to 26.3)
SecondaryPercent of Participants With Distant Disease Progression at 5 Years

Distant disease progression is defined as the first appearance of disease in a non-regional lymph node, solid organ or bone. Time to distant disease progression is defined as time from registration to the date of first distant disease progression, last known follow-up (censored), or death without distant disease progression (competing risk). Distant disease progression rate is estimated using the cumulative incidence method.

Time frame:
From registration to five years
Reported as:
Number · percentage of participants
Percent of Participants With Distant Disease Progression at 5 Years
percentage of participants3DCRT + CT
Percent of Participants With Distant Disease Progression at 5 Years18.7 (7.4 to 34.0)
SecondaryPercentage of Participants With Progression to Tumor Stage T2 or Greater at 3 Years

Primary tumor stage T2 = tumor invades muscle; T3 = tumor invades perivesical tissue; T4 = tumor invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall. Time to progression is defined as time from registration to the date of first progression, last known follow-up (censored), or death without tumor progression (competing risk). Tumor progression rates was to be estimated using the cumulative incidence method.

Time frame:
From registration to three years

No measurements were reported for this outcome.

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

Primary tumor stage T2 = tumor invades muscle; T3 = tumor invades perivesical tissue; T4 = tumor invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall. Time to progression is defined as time from registration to the date of first progression, last known follow-up (censored), or death without tumor progression (competing risk). Tumor progression rate was to be estimated using the cumulative incidence method.

Time frame:
From registration to five years

No measurements were reported for this outcome.

SecondaryPercentage of Participants Who Have Died From Bladder Cancer at 5 Years (Disease-specific Survival)

Time to death from bladder cancer is defined as time from registration to death from bladder cancer, last known follow-up (censored), or death from other cause (competing risk). More specifically, death absent a distant metastasis, death from non-bladder cancer, and death absent local recurrence comprise the competing risk. Death from bladder cancer rate is estimated using the cumulative incidence method.

Time frame:
From registration to five years
Reported as:
Number · percentage of participants
Percentage of Participants Who Have Died From Bladder Cancer at 5 Years (Disease-specific Survival)
percentage of participants3DCRT + CT
Percentage of Participants Who Have Died From Bladder Cancer at 5 Years (Disease-specific Survival)25.1 (11.5 to 41.3)
SecondaryPercentage of Participants Alive at 3 Years

Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.

Time frame:
From registration to three years
Reported as:
Number · percentage of participants
Percentage of Participants Alive at 3 Years
percentage of participants3DCRT + CT
Percentage of Participants Alive at 3 Years69.2 (53.3 to 85.2)
SecondaryPercentage of Participants Alive at 5 Years

Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.

Time frame:
From registration to five years
Reported as:
Number · percentage of participants
Percentage of Participants Alive at 5 Years
percentage of participants3DCRT + CT
Percentage of Participants Alive at 5 Years56.4 (39.1 to 73.7)
SecondaryDistribution of Participants by Highest Grade Adverse Event

Common Terminology Criteria for Adverse Events (CTCAE) version 4 grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

Time frame:
Adverse events are evaluated 8-10 weeks after end of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for 3 years, then annually. Maximum follow-up at time of reporting was 8.6 years.
Reported as:
Count of participants · Participants
Distribution of Participants by Highest Grade Adverse Event
Participants3DCRT + CT
Grade 12
Grade 29
Grade 320
Grade 42
Grade 50
SecondaryPercentage of Participants With Local Recurrence at 3 Years

Time to local recurrence is defined as time from registration to the date of first local recurrence, last known follow-up (censored), or death without local recurrence (competing risk). Local recurrence rate is estimated using the cumulative incidence method.

Time frame:
From registration to three years
Reported as:
Number · percentage of participants
Percentage of Participants With Local Recurrence at 3 Years
percentage of participants3DCRT + CT
Percentage of Participants With Local Recurrence at 3 Years32.5 (17.4 to 48.6)
SecondaryAmerican Urological Association Total Symptom Score at Baseline and at 3 Years

The American Urological Association Total symptom score measures the severity of enlarged prostate symptoms. Possible scores range from 0 to 35, with higher scores indicating worse symptoms.

Time frame:
Baseline and 3 years
Reported as:
Mean · units on a scale
American Urological Association Total Symptom Score at Baseline and at 3 Years
units on a scale3DCRT + CT
Baseline9.84 ± 6.47
Three years12.00 ± 9.25

Adverse events

Collected over Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
3DCRT + CT15/34 (44.1%)7/34 (20.6%)33/34 (97.1%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
Event3DCRT + CT
Urinary tract infectionInfections and infestations2/34
Atrial fibrillationCardiac disorders1/34
Duodenal ulcerGastrointestinal disorders1/34
Mucositis oralGastrointestinal disorders1/34
FeverGeneral disorders1/34
Non-cardiac chest painGeneral disorders1/34
Lung infectionInfections and infestations1/34
Tooth infectionInfections and infestations1/34
Neutrophil count decreasedInvestigations1/34
DehydrationMetabolism and nutrition disorders1/34
Most frequent other events
Showing 10 of 80
Most frequent other events
Event3DCRT + CT
FatigueGeneral disorders28/34
Urinary frequencyRenal and urinary disorders24/34
DiarrheaGastrointestinal disorders21/34
AnemiaBlood and lymphatic system disorders20/34
ConstipationGastrointestinal disorders17/34
Lymphocyte count decreasedInvestigations16/34
HyperglycemiaMetabolism and nutrition disorders15/34
NauseaGastrointestinal disorders14/34
Platelet count decreasedInvestigations14/34
Creatinine increasedInvestigations12/34

Baseline characteristics

Eligible participants who started study treatment

Age, Customized
Age, Customized(Participants)3DCRT + CT
Years — ≤ 594
Years — 60-6912
Years — 70-7914
Years — ≥ 804
Sex: Female, Male
Sex: Female, Male(Participants)3DCRT + CT
Female3
Male31
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)3DCRT + CT
Hispanic or Latino0
Not Hispanic or Latino34
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)3DCRT + CT
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American2
White32
More than one race0
Unknown or Not Reported0
Zubrod
Zubrod(Participants)3DCRT + CT
029
15
08

Study locations

13 sites
  • Emory Crawford Long Hospital
    Atlanta, Georgia 30308, United States
  • Winship Cancer Institute of Emory University
    Atlanta, Georgia 30322, United States
  • St. Agnes Hospital Cancer Center
    Baltimore, Maryland 21229, United States
  • Hudner Oncology Center at Saint Anne's Hospital - Fall River
    Fall River, Massachusetts 02721, United States
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756-0002, United States
  • Beth Israel Medical Center - Petrie Division
    New York, New York 10003-3803, United States
  • Summa Center for Cancer Care at Akron City Hospital
    Akron, Ohio 44309-2090, United States
  • Barberton Citizens Hospital
    Barberton, Ohio 44203, United States
  • Cancer Care Center, Incorporated
    Salem, Ohio 44460, United States
  • Cancer Treatment Center
    Wooster, Ohio 44691, United States
  • Fox Chase Cancer Center - Philadelphia
    Philadelphia, Pennsylvania 19111-2497, United States
  • University of Texas Medical Branch
    Galveston, Texas 77555-0361, United States
  • Norris Cotton Cancer Center - North
    Saint Johnsbury, Vermont 05819, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 1, 2019
  • Informed consent form · Feb 1, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00981656
Lead sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology
Responsible party
Sponsor
First posted
Sep 22, 2009
Start date
Nov 2009
Primary completion
Mar 2021
Completion
Aug 15, 2023
Results posted
Apr 25, 2022
Last update
Sep 19, 2024

Study contacts

William U. Shipley, MD, FACR
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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