Neoplasms

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Carcinoma, Transitional Cell

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Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Urologic Diseases

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Niacinamide

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Nicotinamide

Nicotinic Acid

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Vitamin B9

niacinamide

carbogen

radiation therapy

Peter J. Hoskin, MD

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.

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.

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

Mount Vernon Cancer Centre at Mount Vernon Hospital

Symptoms and General Pathology

Hypoxia

Signs and Symptoms, Respiratory

Antineoplastic Agents

Etanidazole

PET Scan

Carbogen

Dichloroacetate

Dr. Billy W. Loo Jr. M.D. Ph.D.

Hypoxia, meaning a lack of oxygen, has been associated strongly with a wide range of human cancers. Hypoxia occurs when tumor growth exceeds the ability of blood vessels to supply the tumor with oxygenated blood. It is currently understood that hypoxic tumors are more aggressive. Current methods for measuring hypoxia include invasive procedures such as tissue biopsy, or insertion of an electrode into the tumor. EF5-PET may be a non-invasive way to measure tumor hypoxia.

To establish PET imaging with the tracer EF5 as an accurate and reliable method for measuring the oxygen content of a tumor and to establish the measurement of secreted markers in blood as an accurate and reliable method for measuring the oxygen content of a tumor.

Imaging and Biomarkers of Hypoxia in Solid Tumors

Stanford University

Associate Professor of Radiation Oncology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer	NCT00033436	Bladder Cancer	niacinamide carbogen radiation thera...	18 Years -	National Cancer Institute (NCI)
Imaging and Biomarkers of Hypoxia in Solid Tumors	NCT01123005	Neoplasms	PET Scan EF5 Carbogen Dichloroacetate	18 Years -	Stanford University
Imaging and Biomarkers of Hypoxia in Solid Tumors	NCT01123005	Neoplasms	PET Scan EF5 Carbogen Dichloroacetate	18 Years -	Stanford University
Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer	NCT00033436	Bladder Cancer	niacinamide carbogen radiation thera...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for carbogen

Every month we try and update this database with for carbogen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for carbogen

Every month we try and update this database with for carbogen cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for carbogen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.