Clinical trial · Interventional
Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer
A RANDOMIZED TRIAL OF RADICAL RADIOTHERAPY IN pT1G3 NXM0 BLADDER CANCER
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCG vaccine | Biological | — | UNRESOLVED |
| mitomycin C | Drug | Mitomycin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of transitional cell carcinoma of the bladder
* Stage T1 Nx M0, grade 3 disease
* No muscle invasion at base of tumor
* Diagnosis of this stage made within the past 6 months
* Earlier diagnosis of tumors with lower stage or grade allowed
* No history of higher stage urothelial tumors
* Presence of partial involvement of bladder with carcinoma in situ (CIS) or asymptomatic widespread CIS allowed
* No widespread CIS causing severe symptoms
* Prior complete transurethral resection of tumor with deep biopsy of underlying bladder wall required
* Disease currently amenable to adjuvant radiotherapy, followed by cystoscopy with biopsies
PATIENT CHARACTERISTICS:
Age:
* Any age
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No other prior or concurrent malignancy except nonmelanomatous skin cancer or cervical intraepithelial neoplasia
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No more than 1 prior adjuvant treatment with intravesical BCG
Chemotherapy:
* No more than 1 prior adjuvant treatment with intravesical chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
Surgery:
* See Disease Characteristics
* Diathermic removal of associated small papillary growths allowedReferences
Publications (1)
- RESULTHarland SJ: A randomised trial of radical radiotherapy in pT1G3 NXM0 bladder cancer (MRC BS06). [Abstract] J Clin Oncol 23 (Suppl 16): A-4505, 379s, 2005.