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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

Study 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 weeks
Treatment ~ Varies
Follow Up ~from registration to three years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration to three years for reporting.

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 more

Side effects data

From 2010 Phase 2 trial • 13 Patients • NCT02006667
46%
Platelet count decreased
38%
Nausea
23%
Fatigue
23%
Vomiting
23%
Chills
23%
White blood cell decreased
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%
Nail infection
8%
Bronchial infection
8%
Peripheral sensory neuropathy
8%
Alkaline phosphatase increased
8%
Sinus bradycardia
8%
Eyelid function disorder
8%
Bone pain
8%
Non-cardiac chest pain
8%
General disorders and administration site conditions-other
8%
Infections and infestations-others
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
64,890 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,116 Total Patients Enrolled
NRG OncologyOTHER
231 Previous Clinical Trials
100,815 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00981656 — Phase 2
Bladder Cancer Research Study Groups: 3DCRT + CT
Bladder Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT00981656 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00981656 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any prior investigations into the effects of mitomycin C?

"First researched in 1997, mitomycin C has since been tested in 1452 trials with 945 currently enrolling. Notably, a large number of these studies are being conducted by medical centres located near Fall River, Massachusetts."

Answered by AI

What is the aggregate amount of participants enrolled in this clinical trial?

"This investigation is not enrolling patients at this time, having been first posted on November 1st 2009 and last updated March 28th 2022. If you're interested in other clinical studies, 372 trials related to bladder cancer are actively recruiting while 945 experiments concerning mitomycin C still need participants."

Answered by AI

Does the age limitation of this research encompass persons aged 30 and over?

"This trial necessitates that potential participants are between the ages of 18 and 120. Additionally, there are 73 medical studies designed for people below eighteen years old, with 1266 trials created specifically for those over the age of sixty-five."

Answered by AI

How many facilities can participants access this investigation?

"For this medical trial, there are 13 centres actively recruiting patients. These include the Winship Cancer Institute of Emory University in Fall River, HUDNER Oncology Center at Saint Anne's Hospital - Fall River in New york and Beth Israel Medical Centre - Petrie Division in Barberton; as well as 10 other locations."

Answered by AI

Has mitomycin C obtained sanction from the Federal Drug Administration?

"Based on the information we have, mitomycin C was assigned a safety score of 2. As this is only Phase 2 testing, there are some data supporting its security profile but none that demonstrate efficacy."

Answered by AI

In what situations is mitomycin C most commonly employed?

"Mitomycin C is a popular choice for treating neoplasm metastasis, but can also palliate the effects of conditions such as actinic keratosis, cancer, anal disease and advanced directives."

Answered by AI

Is enrollment open for this medical experiment?

"This medical trial is recruiting 37 participants suffering from bladder cancer aged between 18 and 120. In order to be eligible, applicants must have a pathologically proven diagnosis of carcinoma within 105 days prior to registration and either an operable high grade urothelial carcinoma stage T1 or Ta without hydronephrosis at initial presentation which has recurred no more than 540 days after completion of the treatment with transurethral resection of the tumour (TURBT) and intravesical Bacillus Calmette Guerin immunotherapy. Furthermore, if their initial tumor was a high grade Ta , then upon relapse it must"

Answered by AI

Are there vacancies remaining in this clinical trial?

"This trial has ended its recruitment period and is no longer accepting new participants. It was initially posted on November 1st 2009, with the last update taking place on March 28th 2022. For those seeking other medical trials to join, there are presently 372 studies for bladder cancer, cancer and 945 involving mitomycin C that are still enrolling patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer
2009. "Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00981656.
~2 spots leftby Apr 2025
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