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Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia Clinical research trials and Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia. Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia  Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia
Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia
For Condition: radiation toxicity,oral complications of chemotherapy and head and neck radiation,Hypopharyngeal Cancer,Oropharyngeal Cancer
Status: Recruiting
Sponsor(s): National Cancer Research Institute (NCRI) ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy delivers thin beams of radiation of different strengths directly to the tumor from many angles. This type of radiation therapy may reduce damage to the parotid (salivary) glands, prevent xerostomia (dry mouth), and improve quality of life. It is not yet known whether intensity-modulated radiation therapy is more effective than conventional radiation therapy in preventing xerostomia and improving quality of life in patients who have throat cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of intensity-modulated radiation therapy with that of conventional radiation therapy in treating patients with oropharyngeal or hypopharyngeal cancer who are at risk of developing radiation-induced xerostomia (dry mouth caused by radiation therapy).
Details: OBJECTIVES: Primary - Compare the proportion of patients with oropharyngeal or hypopharyngeal cancer with xerostomia of ≥ grade 2 at one year after treatment with parotid-sparing intensity-modulated radiotherapy vs conventional radiotherapy. Secondary - Compare the degree of xerostomia by quantitative measurements of stimulated and unstimulated salivary flow in patients treated with these regimens. - Compare quality of life in patients treated with these regimens. - Compare local and regional tumor control, time to tumor progression, and overall survival of patients treated with these regimens. - Compare acute and late side effects of these regimens in these patients. OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center and site of disease (oropharynx vs hypopharynx). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo parotid-sparing intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. - Arm II: Patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks. Salivary flow measurements are performed at baseline, at week 4 during radiotherapy, and then at 2 weeks and at 3, 6, 12, and 24 months after the completion of radiotherapy. Quality of life is assessed at baseline, at 2 weeks, and then at 3, 6, 12, 18, and 24 months after the completion of radiotherapy. Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 84 patients (42 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed oropharyngeal or hypopharyngeal cancer - Squamous cell or undifferentiated carcinoma - Stage T1-4, N0-3, M0 disease - Primary tumor requiring radical radiotherapy with parallel opposed lateral fields and bilateral cervical lymph node irradiation - Radiotherapy is either the primary therapy or post-operative (adjuvant irradiation) treatment - High-risk for radiation-induced xerostomia with conventional radiotherapy due to irradiation of the majority of both parotid glands* NOTE: *Estimated mean dose to both parotid glands is greater than 24 Gy by conventional radiotherapy - No bilateral N3 nodal disease - No huge primary tumor (exceeding 10 cm in diameter) - No contralateral lymphadenopathy adjacent to or involving contralateral parotid gland making parotid sparing impossible - No tumor at the base of the tongue where sparing of contralateral parapharyngeal space is contraindicated PATIENT CHARACTERISTICS: Age - Not specified Performance status - WHO 0-1 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Able to undergo quality of life and salivary flow measurements (dependent on cognitive aptitude and long availability) - Able to complete self-assessed quality of life questionnaire - No prior or concurrent illness that would preclude study participation - No pre-existing salivary gland pathology interfering with saliva production - No other prior malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Prior neoadjuvant chemotherapy allowed - No concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy to the head and neck region - No concurrent brachytherapy Surgery - See Disease Characteristics Other - No concurrent prophylactic amifostine or pilocarpine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChrisNutting, Study Chair, Royal Marsden NHS Trust
Royal Marsden NHS Trust - London *Recruiting*
London, England, SW3 6JJ
United Kingdom
Recruiting Chris Nutting 44-020-7808-2586
Additional Information:
Study ID Numbers: CDR0000358803; ISRCTN48243537,EU-20304,ICR-PARSPORT,MREC-03679
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081029
Other Hypopharyngeal Cancer Studies:
1. Benzydamine in Treating Radiation-Induced Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx
2. BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
3. Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
4. Gene Therapy in Preventing Cancer in Patients With Premalignant Carcinoma of the Oral Cavity or Pharynx
5. Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
Related Studies:
Other Hypopharyngeal Cancer Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia
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