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Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx Clinical research trials and Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx. Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx clinical trial. Test subjects typically receive the most expert healthcare available for their Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx  Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx
Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx
For Condition: stage 2 squamous cell carcinoma of the lip and oral cavity,stage 3 squamous cell carcinoma of the lip and oral cavity,stage 4 squamous cell carcinoma of the lip and oral cavity,stage 2 squamous cell carcinoma of the oropharynx,stage 3 squamous cell carcinoma of the oropharynx,stage 4 squamous cell carcinoma of the oropharynx
Status: Recruiting
Sponsor(s): European Institute of Oncology ,
Synopsis: RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells of the mouth or oropharynx. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not known whether giving interleukin-2 with surgery and radiation therapy is more effective than surgery and radiation therapy alone. PURPOSE: Randomizedphase III trial to compare the effectiveness of surgery and radiation therapy with or without interleukin-2 in treating patients with cancer of the mouth or oropharynx.
Details: OBJECTIVES: - Compare the disease-free and overall survival in patients with previously untreated squamous cell carcinoma of the oral cavity or oropharynx treated with resection with or without and neoadjuvant and adjuvant perilymphatic interleukin-2 (IL-2) and radiotherapy. - Compare the response rate in patients treated with these regimens. - Determine the local and systemic effects of locoregional IL-2 on host-tumor interaction and immune properties in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and tumor stage (T2, N0-2 vs T2, N3 or T3-4, N0-3). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo induction comprising interleukin-2 (IL-2) via perilymphatic injections to the ipsilateral myelohyoid muscle and insertion of the sternocleidomastoid muscle on days 1-5 and 8-12. Within 10 days after the last IL-2 injection, patients undergo en bloc resection of the primary tumor and corresponding lymphatic drainage area and pre-study margins. Beginning within 4 weeks after surgery, patients with T2, N0-3 disease but with pathohistological evidence of node invasion or capsular rupture of node metastasis or T3-4, N0-3 disease undergo adjuvant radiotherapy 5 days a week for 4.5-6.5 weeks. Beginning within 4 weeks after surgery or radiotherapy (if applicable), patients receive adjuvant IL-2 via perilymphatic injections to the contralateral myelohyoid muscle and insertion of the sternocleidomastoid muscle on days 1-5. Adjuvant IL-2 continues monthly for at least 1 year in the absence of disease progression. - Arm II: Patients undergo resection and radiotherapy (if eligible) as in arm I. Patients are followed monthly for 1 year and then every 2 months for 2 years. PROJECTED ACCRUAL: A total of 260 patients (130 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven squamous cell carcinoma of the oral cavity or oropharynx - Operable, primary, unilateral, stage T2-4, N0-3, M0 disease - No high probability of bilateral lymphatic spread (requirement for bilateral neck dissection) - No tumor involvement of the following sites: - Pterygopalatine fossa - Carotid artery - Maxillary sinus - Facial skin - Anterior floor of the mouth - Base of the tongue infiltrating more than 1 cm - Measurable or evaluable disease by physical exam and/or noninvasive imaging PATIENT CHARACTERISTICS: Age: - 75 and under Performance status: - ECOG 0-2 OR - Karnofsky 70-100% Life expectancy: - More than 3 months Hematopoietic: - WBC at least 4,000/mm3 - Platelet count at least 60,000/mm3 - Hematocrit at least 30% Hepatic: - Bilirubin normal - Hepatitis B surface antigen negative Renal: - Creatinine normal Cardiovascular: - No congestive heart failure - No uncontrolled hypertension - No coronary artery disease - No serious arrhythmia - No evidence of prior myocardial infarction on ECG (stress test required if in doubt) Other: - HIV negative - No autoimmune disease - No contraindications to pressor agents - No serious infection requiring antibiotics - No other concurrent primary malignancy - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior or other concurrent immunotherapy Chemotherapy: - No prior or concurrent chemotherapy Endocrine therapy: - No prior or concurrent hormonal therapy - No concurrent corticosteroids Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics - No prior major organ allografts Other: - No other prior therapy - No other concurrent investigational drugs, agents, or devices - No concurrent nonsteroidal antiinflammatory drugs, ranitidine, cimetidine, or coumarin
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GiorgioCortesina, Study Chair, Universita Degli Studi di Torino
Universita Degli Studi di Bari Policlinico *Recruiting*
Bari, , 70124
Italy
Recruiting G. Cervellera 39-080-547-8660
Universita di Ferrara *Recruiting*
Ferrara, , 44100
Italy
Recruiting C. Calearo 39-0532-209-296
Cattedra di Oncologia Medica - Universita degli Studi di Cagliari *Recruiting*
Cagliari, , 09124
Italy
Recruiting P. Puxeddu 39-070-602-8253
Ospedale San Bortolo *Recruiting*
Vicenza, , 36100
Italy
Recruiting C. Curioni 39-0444-993-906
Universita di Torino *Recruiting*
Turin, , 10126
Italy
Recruiting G. Valente 39-011-670-5955
Universita Degli Studi di Firenze - Policlin. di Careggi *Recruiting*
Firenze (Florence), , 1 (50134)
Italy
Recruiting O. Fini-Storchi 39-55-411739
Cattedra di Immunologia Clinica *Recruiting*
Turin (TO), , 10128
Italy
Recruiting G. Forni 39-011-508-2651
Additional Information:
Study ID Numbers: CDR0000064500; CNR-9506,EU-95024
Study Start Date:
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002702
Other Stage 3 Squamous Cell Carcinoma Of The Oropharynx Studies:
1. Biafine Cream to Reduce Side Effects of Radiation Therapy in Patients Receiving Treatment for Head and Neck Cancer
2. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
3. Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer
4. Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx
5. Chemotherapy With or Without Docetaxel Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx
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