Clinical trial · Interventional
Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer
A Multicenter Randomized Trial of Radical Radiotherapy With Carbogen in the Radical Treatment of Locally Advanced 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 such as carbogen and niacinamide may make tumor cells more sensitive to radiation therapy. It is not yet known whether radiation therapy is more effective with or without carbogen and niacinamide in treating patients who have bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without carbogen and niacinamide in treating patients who have locally advanced 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 |
|---|---|---|---|
| carbogen | Drug | — | UNRESOLVED |
| niacinamide | Dietary Supplement | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Cystoscopic response at 6 months after initiation radiotherapy
- measure
- Local failure-free survival
- measure
- Overall disease-specific survival
Secondary outcomes (2)
- measure
- Treatment related morbidity (i.e., acute and chronic bowel and bladder symptoms)
- measure
- Quality of life as assessed by FACT-BI scale at baseline, week 4, 3 months, 6 months, 12 months, and yearly thereafter for 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed transitional cell carcinoma of the bladder * Muscle invasive carcinoma (stage T2 or T3) of any grade OR * High-grade (G3) superficial bladder carcinoma (T1) OR * Prostatic invasion (T4a) * No squamous cell carcinoma or adenocarcinoma of the bladder * No locally advanced T4b carcinoma * No distant metastasis or enlarged pelvic lymph nodes on CT staging scan of the pelvis PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2 times normal Renal: * Creatinine no greater than 2 times normal Cardiovascular: * No ischemic heart disease or peripheral vascular disease requiring diuretics or angiotensin-converting enzyme inhibitors Pulmonary: * No concurrent respiratory disease with reduced respiratory drive that would preclude the delivery of 95% oxygen Other: * Capable of complying with a closed breathing system delivering carbogen through either a mask or a mouthpiece with nasal clip PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified
References
Publications (2)
- RESULTHoskin PJ, Rojas AM, Saunders MI, Bentzen SM, Motohashi KJ; BCON investigators. Carbogen and nicotinamide in locally advanced bladder cancer: early results of a phase-III randomized trial. Radiother Oncol. 2009 Apr;91(1):120-5. doi: 10.1016/j.radonc.2008.10.001. Epub 2008 Nov 5. PMID 18992952
- DERIVEDChoudhury A, Porta N, Hall E, Song YP, Owen R, MacKay R, West CML, Lewis R, Hussain SA, James ND, Huddart R, Hoskin P; BC2001 and BCON investigators. Hypofractionated radiotherapy in locally advanced bladder cancer: an individual patient data meta-analysis of the BC2001 and BCON trials. Lancet Oncol. 2021 Feb;22(2):246-255. doi: 10.1016/S1470-2045(20)30607-0. PMID 33539743