Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2002 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Mount Vernon Cancer Centre at Mount Vernon Hospital
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00033436
First received: April 9, 2002
Last updated: September 17, 2009
Last verified: December 2002
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Dietary Supplement: niacinamide Drug: carbogen Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Multicenter Randomized Trial of Radical Radiotherapy With Carbogen in the Radical Treatment of Locally Advanced Bladder Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Cystoscopic response at 6 months after initiation radiotherapy [ Designated as safety issue: No ]
- Local failure-free survival [ Designated as safety issue: No ]
- Overall disease-specific survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Treatment related morbidity (i.e., acute and chronic bowel and bladder symptoms) [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
| Estimated Enrollment: | 330 |
| Study Start Date: | October 2000 |
OBJECTIVES:
- Compare the 6-month cystoscopic response in patients with locally advanced transitional cell carcinoma of the bladder treated with radical radiotherapy with or without radiosensitization with carbogen and niacinamide.
- Compare the local failure-free and overall disease-specific survival of patients treated with these regimens.
- Compare the treatment-related morbidity, in particular acute and chronic bowel and bladder symptoms, in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive radical radiotherapy once daily, 5 days a week, for 4-6.4 weeks. Patients also receive oral niacinamide once daily 1.5-2 hours before initiation of each radiotherapy dose and carbogen through a closed breathing system (face mask with a tight air seal or a mouthpiece with nasal clip) once daily beginning 5 minutes before initiation and continuing until completion of each radiotherapy dose.
- Arm II: Patients receive radiotherapy as in arm I. Quality of life is assessed at baseline; at 4 weeks; at 3, 6, and 12 months; and then annually for 4 years.
Patients are followed at 8 and 12 weeks; at 6, 9, and 12 months; and then every 6 months for 4 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 330 patients (165 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033436
Locations
| United Kingdom | |
| Sussex Cancer Centre at Royal Sussex County Hospital | |
| Brighton, England, United Kingdom, BN2 5BF | |
| Bristol Haematology and Oncology Centre | |
| Bristol, England, United Kingdom, BS2 8ED | |
| Kent and Canterbury Hospital | |
| Canterbury, England, United Kingdom, CT2 3NG | |
| Derbyshire Royal Infirmary | |
| Derby, England, United Kingdom, DE1 2QY | |
| Ipswich Hospital NHS Trust | |
| Ipswich, England, United Kingdom, IP4 5PD | |
| Cookridge Hospital at Leeds Teaching Hospital NHS Trust | |
| Leeds, England, United Kingdom, LS16 6QB | |
| Christie Hospital NHS Trust | |
| Manchester, England, United Kingdom, M20 4BX | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Northern Centre for Cancer Treatment at Newcastle General Hospital | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | |
| Northwood, England, United Kingdom, HA6 2RN | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Oldchurch Hospital | |
| Romford, England, United Kingdom, RM7 OBE | |
| Cancer Research Centre at Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Velindre Cancer Center at Velindre Hospital | |
| Cardiff, Wales, United Kingdom, CF14 2TL | |
Sponsors and Collaborators
Mount Vernon Cancer Centre at Mount Vernon Hospital
Investigators
| Study Chair: | Peter J. Hoskin, MD | Mount Vernon Cancer Centre at Mount Vernon Hospital |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00033436 History of Changes |
| Other Study ID Numbers: | CDR0000069283, MTVERNHOSP-BCON, EU-20051 |
| Study First Received: | April 9, 2002 |
| Last Updated: | September 17, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I bladder cancer stage II bladder cancer stage III bladder cancer transitional cell carcinoma of the bladder |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Niacinamide Niacin Nicotinic Acids Carbogen Vitamin B Complex Vitamins |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 23, 2013