Radiation Therapy, Chemotherapy, or Observation in Treating Patients With

Status Completed

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not known whether receiving either radiation therapy, chemotherapy, or observation is more effective for cancer of the bladder.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, chemotherapy, or observation following tumor surgery in treating patients who have bladder cancer.

Clinical Trial Description

OBJECTIVES:

- Compare the efficacy of adjuvant radical radiotherapy vs intravesical BCG or mitomycin vs observation alone after endoscopic resection in terms of the progression rate and survival of patients with stage I, grade 3 transitional cell carcinoma of the bladder.

- Determine the toxicity of radical radiotherapy in these patients.

- Determine the incidence of carcinoma in situ elsewhere in the bladder and its correlation with the subsequent clinical outcome of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, extent of tumor (single tumor without carcinoma in situ (CIS) vs multiple tumors or CIS), and WHO performance status. Patients with a single tumor and no CIS are randomized to arm I or II. Patients with multiple tumors or CIS are randomized to arm II or III.

- Arm I: Patients undergo observation only.

- Arm II: Patients undergo radical radiotherapy 5 days a week for 6 weeks. Patients found to be node positive on CT scan may undergo pelvic irradiation and remain on study.

- Arm III: Patients receive intravesical BCG or mitomycin (at the discretion of the physician) weekly for 6-12 weeks.

Patients on arms I and III are followed at 3 months after randomization. All patients are followed at 6, 9, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study. ;

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00002490
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 3
Start date	September 1991

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06034015` - A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers	Phase 1
Recruiting	`NCT04235764` - En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
Completed	`NCT02371447` - VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer	Phase 1/Phase 2
Recruiting	`NCT04081246` - Transurethral Modified En Bloc Resection For Large Bladder Tumours.	N/A
Recruiting	`NCT06059547` - Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer	Phase 2
Terminated	`NCT04779489` - Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer	N/A
Not yet recruiting	`NCT04493489` - Propranolol Adjuvant Treatment of Bladder Cancer	Phase 2
Completed	`NCT03520231` - Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases	Phase 2
Recruiting	`NCT04537221` - Nordic Cystectomy Study III - Transfusion
Withdrawn	`NCT03007771` - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia	Phase 1
Completed	`NCT01955408` - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment	N/A
Completed	`NCT04487457` - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Active, not recruiting	`NCT04383210` - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors	Phase 2
Recruiting	`NCT05562791` - A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer	Phase 1
Completed	`NCT00199849` - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine	Phase 1
Completed	`NCT02781428` - To Detect the Sensitivity of the UroMark Assay
Recruiting	`NCT04738630` - Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer	Phase 2
Completed	`NCT03980041` - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)	Phase 2
Active, not recruiting	`NCT03978624` - Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer	Phase 2
Completed	`NCT04534309` - Behavioral Weight Loss Program for Cancer Survivors in Maryland	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms