|
Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx Clinical research trials and Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx. Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx clinical trial. Subjects frequently obtain the most expert healthcare possible for their Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "M" Clinical Trials Conditions > Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx  Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
For Condition: Hypopharyngeal Cancer,Laryngeal Cancer,Oropharyngeal Cancer,Nasopharyngeal Cancer,oral complications of cancer and cancer therapy,lip and oral cavity cancer
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy at different times of the day may affect the chance of developing side effects such as mucositis. PURPOSE: Randomizedphase III trial to compare the incidence of mucositis in patients who have cancer of the mouth, pharynx, or larynx who are receiving radiation therapy in either the morning or afternoon.
Details: OBJECTIVES: - Compare the toxicity of radiotherapy to the oral mucosa delivered in the morning or in the late afternoon in patients with squamous cell carcinoma of the oral cavity, pharynx (oro/hypo/naso), or larynx who will receive radiation treatment to a significant part of the oral and/or oropharyngeal mucosa. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to study center, intended smoking behavior during therapy (smoking vs nonsmoking), and planned total radiotherapy dose. Patients are randomized to receive identical radiotherapy once daily, 5 days a week, at one of two of the following times of the day: - Arm I: Patients receive radiotherapy between 8 and 10 AM (local time). - Arm II: Patients receive radiotherapy between 4 and 6 PM (local time). Treatment continues for 5-7 weeks, depending on planned total radiotherapy dose, in the absence of unacceptable toxicity or disease progression. Toxicity is assessed at the first fraction of radiotherapy, weekly during treatment, weekly until mucositis has peaked and is improving, and then every 2 weeks until mucositis has improved to less than grade 2. Quality of life is assessed at baseline, weekly during treatment and until toxicity has peaked and is improving, every 2 weeks until toxicity is less than grade 2 mucositis, and then at each follow-up visit until week 24. Patients are followed annually for 3 years. PROJECTED ACCRUAL: A total of 216 patients (108 per arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the oral cavity, pharynx (oropharynx, hypopharynx, or nasopharynx), or larynx eligible for radical radiotherapy - TX, T1-4, NX, N0-3, M0 - Directly visible area of mucosa including 2 or more protocol specified anatomical locations in the radical target volume - At least 6 cm^2 in area irrespective of shape - No M1 disease - Intention to deliver radiotherapy to a radical dose without chemotherapy - May have had surgical resection of the primary or neck nodes - Postoperative macroscopic or microscopic residual disease that is eligible for radical radiotherapy is allowed - Patients with completely resected disease who are judged to be at high risk of relapse and who are eligible for radical radiotherapy are allowed PATIENT CHARACTERISTICS: Age: - 16 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Hemoglobin at least 10 g/dL - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - Must have normal sleeping habits (i.e., normal circadian rhythm) - Must have had dental assessment and necessary prophylactic dental extractions carried out - No connective tissue diseases (e.g., systemic lupus, scleroderma, mixed connective tissue disease, rheumatoid arthritis) - No organic brain syndrome related to chronic alcohol excess or other cause of sufficient severity to preclude cooperation with treatment - No active uncontrolled infection - No history of psychiatric or neurological disorder that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - At least 6 months since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No prior radiotherapy to the head and neck region Surgery: - See Disease Characteristics Other: - No other concurrent oral hygiene regimen other than that described in the protocol - No concurrent radioprotective drugs or therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgBjarnason, Study Chair, Toronto Sunnybrook Regional Cancer Centre
Centre Hospitalier Universitaire de Quebec *Recruiting*
Quebec City, Quebec, G1R 2J6
Canada
Recruiting Andre Fortin 418-691-5264
McGill University *Recruiting*
Montreal, Quebec, H3G 1A4
Canada
Recruiting Silvy Lachance 514-934-1934 ext. 43118
McGill University *Recruiting*
Montreal, Quebec, H2W 1S6
Canada
Recruiting Khalil Sultanem 514-340-8288
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K1H 1C4
Canada
Recruiting Laval Grimard 613-737-7700 ext. 6860
Saskatoon Cancer Centre *Recruiting*
Saskatoon, Saskatchewan, S7N 4H4
Canada
Recruiting David Skarsgard 306-655-2740
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Robert MacKenzie 416-480-6128
British Columbia Cancer Agency - Centre for the Southern Interior *Recruiting*
Kelowna, British Columbia, V1Y 5L3
Canada
Recruiting Jane Wilson 250-712-3900 Ext. 3979
Newfoundland Cancer Treatment and Research Foundation *Recruiting*
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Recruiting Pradip Ganguly 709-777-7805
Northwestern Ontario Regional Cancer Care *Recruiting*
Thunder Bay, Ontario, P7B 6V4
Canada
Recruiting Sunil P. Gulavita 807-684-7200
British Columbia Cancer Agency *Recruiting*
Vancouver, British Columbia, V5Z 4E6
Canada
Recruiting John Hay 604-877-6000 ext. 2660
CHUS-Hopital Fleurimont *Recruiting*
Fleurimont, Quebec, J1H 5N4
Canada
Recruiting Abdenour Nabid 819-346-1110 ext. 14602
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting David Hodson 905-387-9495 ext. 64702
Fraser Valley Cancer Centre at British Columbia Cancer Agency *Recruiting*
Surrey, British Columbia, V3V 1Z2
Canada
Recruiting Eric Berthelet 604-930-4033
CancerCare Manitoba *Recruiting*
Winnipeg, Manitoba, R3E 0V9
Canada
Recruiting Ahmet Leylek 204-787-2117
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Alex Hammond 519-685-8650
Additional Information:
Study ID Numbers: CDR0000067478; CAN-NCIC-HN3
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004234
Other Hypopharyngeal Cancer Studies:
1. Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function
2. Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer
3. Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
4. Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx
5. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
Related Studies:
Other Hypopharyngeal Cancer Clinical Trials
Other Ontario Clinical Trials
Other Thunder Bay Clinical Trials
Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
|
|
|
|
|
|
|
|
