← Back to Search

Platinum-based Chemotherapy

adjuvant gemcitabine for Bladder Cancer

Phase 2
Waitlist Available
Led By John J. Coen, MD
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 randomization to three years
Awards & highlights

Study Summary

This trial is studying two different chemotherapy and radiation therapy regimens to see how they work in treating patients with stage II or stage III bladder cancer.

Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment to five years after the end of therapy. treatment could last up to 40 weeks depending on arm, tumor response, and allowed time ranges.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to five years after the end of therapy. treatment could last up to 40 weeks depending on arm, tumor response, and allowed time ranges. 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 Patients Without Distant Metastases by Three Years
Secondary outcome measures
Change in American Urological Association Symptom Index (AUASI) Score at 3 Years
Determining Potentially Predictive Biomarkers for Acute and Late Toxicities
Cystectomy
+4 more

Side effects data

From 2022 Phase 2 trial • 70 Patients • NCT00777491
88%
Fatigue
85%
Hemoglobin decreased
79%
Nausea
76%
Hyperglycemia
73%
Urinary frequency
70%
Diarrhea
67%
Leukopenia
64%
Constipation
61%
Platelet count decreased
58%
Lymphopenia
58%
Neutrophil count decreased
58%
Hyponatremia
52%
Hypomagnesemia
52%
Insomnia
42%
Creatinine increased
42%
Urogenital disorder
39%
Laboratory test abnormal
39%
Pain [other]
39%
Hypocalcemia
36%
Vomiting
36%
Anorexia
36%
Peripheral sensory neuropathy
33%
Dehydration
30%
Abdominal pain
30%
Alkaline phosphatase increased
30%
Hypokalemia
24%
Back pain
24%
Weight loss
24%
Hypoalbuminemia
21%
Depression
21%
Headache
21%
Blood disorder
21%
Alanine aminotransferase increased
21%
Dizziness
21%
Urinary incontinence
18%
Hypophosphatemia
18%
Muscle weakness
18%
Musculoskeletal disorder
18%
Gastrointestinal disorder
18%
Edema limbs
18%
Cystitis
18%
Dyspnea
15%
Hemorrhage urinary tract
15%
Dyspepsia
15%
Hyperkalemia
15%
Bladder infection [with unknown ANC]
15%
Hyperbilirubinemia
15%
Neurological disorder NOS
15%
Cough
15%
Hypertension
12%
Bladder spasm
12%
Fever
12%
Myalgia
12%
Taste alteration
12%
Urinary retention
12%
Joint pain
12%
Hemorrhage
12%
Hiccough
12%
Alopecia
12%
Skin disorder
9%
Bone pain
9%
Hypotension
9%
Chest pain
9%
General symptom
9%
Pain in extremity
6%
Mucositis oral
6%
Vision blurred
6%
Rectal hemorrhage
6%
Cardiac disorder
6%
Eye disorder
6%
Hemorrhoids
6%
Rectal pain
6%
Stomach pain
6%
Urinary tract infection [with unknown ANC]
6%
Aspartate aminotransferase increased
6%
INR increased
6%
Memory impairment
6%
Peripheral motor neuropathy
6%
Agitation
6%
Anxiety
6%
Bladder pain
6%
Erectile dysfunction
6%
Penile pain
6%
Intraoperative complications
6%
Activated partial thromboplastin time prolonged
6%
Weight gain
6%
Pharyngolaryngeal pain
6%
Voice alteration
6%
Acne
6%
Pruritus
6%
Rash desquamating
3%
Urethral pain
3%
Phlebitis superficial
3%
Infection [other]
3%
Febrile neutropenia
3%
Flatulence
3%
Depressed level of consciousness
3%
Thrombosis
3%
Syncope
3%
Hemolysis
3%
Atrial fibrillation
3%
Ischemia cerebrovascular
3%
Intracranial hemorrhage
3%
Confusion
3%
Renal failure
3%
Proctitis
3%
Chills
3%
Bladder infection [with normal or Grade 1-2 ANC]
3%
Pelvic pain
3%
Flushing
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I
Arm II

Trial Design

2Treatment groups
Experimental Treatment
Group I: Gemcitabine + QD IrradiationExperimental Treatment8 Interventions
Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
Group II: 5-FU and Cisplatin + BID IrradiationExperimental Treatment10 Interventions
Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
consolidation gemcitabine
2008
Completed Phase 2
~70
Consolidation QD radiation therapy
2008
Completed Phase 2
~70
Induction BID radiation therapy
2008
Completed Phase 2
~70
Induction QD radiation therapy
2008
Completed Phase 2
~70
adjuvant gemcitabine
2008
Completed Phase 2
~70
Post-Induction Chemoradiotherapy Endoscopic Response Evaluation
2008
Completed Phase 2
~70
induction cisplatin
2008
Completed Phase 2
~70
induction 5-fluorouracil
2008
Completed Phase 2
~70
induction gemcitabine
2008
Completed Phase 2
~70
Consolidation BID radiation therapy
2008
Completed Phase 2
~70
consolidation 5-fluorouracil
2008
Completed Phase 2
~70
consolidation cisplatin
2008
Completed Phase 2
~70
radical cystectomy
2008
Completed Phase 2
~70
adjuvant cisplatin
2008
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,857 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,253 Total Patients Enrolled
Chin-Lee Wu, MD, PhDStudy ChairMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer That Was Removed by Surgery
2008. "Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer That Was Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00777491.
~4 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top