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Alkylating agents
cisplatin for Bladder Cancer
Phase 2
Waitlist Available
Led By William U. Shipley, MD, FACR
Research Sponsored by Radiation Therapy Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from registration to three years
Awards & highlights
Summary
This trial is studying radiation therapy given with cisplatin to see how well it works in treating patients with stage I bladder cancer.
Eligible Conditions
- Bladder Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ five years from registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~five years from registration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Free From Radical Cystectomy at 3 Years
Secondary outcome measures
American Urological Association Total Symptom Score at Baseline and at 3 Years
Distribution of Participants by Highest Grade Adverse Event
Percent of Participants With Distant Disease Progression at 3 Years
+8 moreSide effects data
From 2010 Phase 2 trial • 13 Patients • NCT0200666746%
Platelet count decreased
38%
Nausea
23%
Chills
23%
Fatigue
23%
White blood cell decreased
23%
Vomiting
23%
Dyspnea
15%
Urinary tract infection
15%
Creatinine increased
15%
Anemia
15%
Weight loss
15%
Investigations-other
15%
Back pain
15%
Paresthesia
15%
Epistaxis
8%
Sinus bradycardia
8%
Non-cardiac chest pain
8%
Bronchial infection
8%
Eyelid function disorder
8%
Bone pain
8%
Infections and infestations-others
8%
Nail infection
8%
General disorders and administration site conditions-other
8%
Peripheral sensory neuropathy
8%
Alkaline phosphatase increased
8%
Diarrhea
8%
Fever
8%
Upper respiratory infection
8%
Confusion
8%
Tachyarrhythmia
8%
Gastrointestinal hermorrhage
8%
Ileus
8%
General disorders-other
8%
Catheter related infection
8%
Hematuria
8%
Urinary tract obstruction
8%
Pleural effusion
8%
Vertigo
8%
Endocrine disorders-other
8%
Neutrophil count decreased
8%
Arthralgia
8%
Pain in extremity
8%
Neck pain
8%
Generalized muscle weakness
8%
Neoplasms benign, malignant and unspecified-others
8%
Depression
8%
Alopecia
8%
Nail ridging
8%
Surgical and medical procedures-others
8%
Chill
8%
Gastrointestinal hemorrhage
8%
Arthritis
8%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab/Gemcitabine/Cisplatin
Trial Design
1Treatment groups
Experimental Treatment
Group I: 3DCRT + CTExperimental Treatment4 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cisplatin
1997
Completed Phase 3
~3290
5-fluorouracil
2005
Completed Phase 4
~7960
Mitomycin
2009
Completed Phase 3
~410
Three-Dimensional Conformal Radiation Therapy
2009
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,889 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,364 Total Patients Enrolled
NRG OncologyOTHER
232 Previous Clinical Trials
100,712 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have a serious bacterial or fungal infection that requires treatment with antibiotics given through a vein.You had an allergic reaction to the study drugs (cisplatin, mitomycin, 5FU) before.You have a serious, ongoing health condition that could interfere with your ability to participate in the study.You have not received chemotherapy specifically for bladder cancer before. However, if you have had chemotherapy for a different type of cancer, that is allowed.You are currently hospitalized or experiencing a severe respiratory illness that would prevent you from participating in the study.
Research Study Groups:
This trial has the following groups:- Group 1: 3DCRT + CT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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