Head and Neck Cancer Clinical Trial
Official title:
A Phase II Trial OF Chemoradiation For Organ Preservation In Resectable Stage III or IV Squamous Cell Carcinomas Of The Larynx Or Oropharynx
Verified date | June 2023 |
Source | Eastern Cooperative Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy and chemotherapy in treating patients who have stage III or stage IV cancer of the larynx or stage III or stage IV cancer of the oropharynx.
Status | Completed |
Enrollment | 0 |
Est. completion date | May 2009 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | DISEASE CHARACTERISTICS: - Histologically confirmed stage III or IV (T2-T4) squamous cell carcinoma of the larynx or oropharynx - No recurrent disease - No evidence of distant metastasis - Resectable disease, defined as follows: - High probability of attaining clear surgical margins (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall) - No extension to root of tongue (for disease of the base of tongue) - No extension into pterygoid by radiograph (for disease of the tonsil, soft palate, or pharyngeal wall) - No primary tumor or nodal metastases fixed to the carotid artery or cervical spine (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall) - No trismus (for disease of the tonsil, soft palate, or pharyngeal wall) - No involvement of the trachea greater than 1 cm or any involvement of the esophagus (for disease of the subglottis) - For disease of the supraglottis, glottis, or subglottis: - No base of the tongue invasion greater than 2 cm - No tumor extension through cartilage to involve strap muscles of the neck - No tumor fixation to prevertebral fascia - No involvement of the carotid artery - No fixed nodal disease with involvement of the deep neck - Extension into pyriform sinus or lateral pharyngeal wall allowed if no extension into posterior pharynx - Measurable disease - - Lesions accurately measured in at least one dimension as > 20 mm (2.0 cm) with conventional techniques or as > 10 mm (1.0 cm) with spiral CT scan - Cytologic or histologic evidence of neoplasm is needed for measurable disease restricted to a solitary lesion - No other concurrent head and neck neoplasms PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Not specified Renal - Creatinine less than 3.0 mg/dL - Calcium normal Cardiovascular - No significant cardiac disease - No uncontrolled hypertension - No unstable angina - No congestive heart failure - No myocardial infarction within the past year - No serious cardiac arrhythmias requiring medication Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study completion - No significant detectable infection - No history of allergy to drugs containing Cremophor EL - No history of allergy to mammalian cell-derived products (epoetin alfa) or human albumin - No other malignancy within the past 3 years except basal or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy - No concurrent amifostine Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy above the clavicles Surgery - No prior surgery to the primary tumor except biopsy or debulking Other - No concurrent experimental mucosal protectants |
Country | Name | City | State |
---|---|---|---|
United States | Aultman Cancer Center at Aultman Hospital | Canton | Ohio |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Hematology and Oncology Associates | Chicago | Illinois |
United States | Mercy Hospital and Medical Center | Chicago | Illinois |
United States | Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois |
United States | MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio |
United States | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas |
United States | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas |
United States | Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin |
United States | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey | Illinois |
United States | Baptist Cancer Institute - Jacksonville | Jacksonville | Florida |
United States | Midwest Center for Hematology/Oncology | Joliet | Illinois |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | Watson Clinic, LLC | Lakeland | Florida |
United States | Southwest Medical Center | Liberal | Kansas |
United States | Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin |
United States | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin |
United States | Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles | Illinois |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | Marshfield Clinic - Indianhead Center | Rice Lake | Wisconsin |
United States | Cancer Center of Kansas, PA - Salina | Salina | Kansas |
United States | Guthrie Cancer Center at Guthrie Clinic Sayre | Sayre | Pennsylvania |
United States | Mercy Medical Center - Sioux City | Sioux City | Iowa |
United States | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa |
United States | St. Luke's Regional Medical Center | Sioux City | Iowa |
United States | Hematology Oncology Associates - Skokie | Skokie | Illinois |
United States | Hematology/Oncology of the North Shore at Gross Point Medical Center | Skokie | Illinois |
United States | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Associates in Womens Health, PA - North Review | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas |
United States | Wesley Medical Center | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
Lead Sponsor | Collaborator |
---|---|
Eastern Cooperative Oncology Group | National Cancer Institute (NCI) |
United States,
Cmelak AJ, Li S, Goldwasser MA, Murphy B, Cannon M, Pinto H, Rosenthal DI, Gillison M, Forastiere AA. Phase II trial of chemoradiation for organ preservation in resectable stage III or IV squamous cell carcinomas of the larynx or oropharynx: results of Ea — View Citation
Cmelak AJ, Li S, Murphy B, et al.: Locally advanced resectable larynx (L) or oropharynx (OP) cancer: updated results of organ preservation trial ECOG 2399. [Abstract] J Clin Oncol 24 (Suppl 18): A-5527, 286s, 2006.
Fakhry C, Westra W, Li S, et al.: Prognostic significance of human papillomavirus (HPV) tumor status for patients with head and neck squamous cell carcinoma (HNSCC) in a prospective, multi-center phase II clinical trial. [Abstract] J Clin Oncol 25 (Suppl
Fakhry C, Westra WH, Li S, Cmelak A, Ridge JA, Pinto H, Forastiere A, Gillison ML. Improved survival of patients with human papillomavirus-positive head and neck squamous cell carcinoma in a prospective clinical trial. J Natl Cancer Inst. 2008 Feb 20;100( — View Citation
Murphy BA, Smith K, Cmelak A, et al.: Swallowing function for patients treated on E2399: a phase II trial of function preservation with induction paclitaxel/carboplatin followed by radiation plus weekly paclitaxel. [Abstract] J Clin Oncol 24 (Suppl 18): A
Murphy BA, Smith K, Dowling E, et al.: Baseline swallowing function for patients treated on E2399: a phase II trial of function preservation with induction paclitaxel/carboplatin followed by radiation plus weekly paclitaxel. [Abstract] Proceedings of the
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Organ preservation rate | |||
Primary | Feasibility and toxicity | |||
Primary | Utility of pre- and post-treatment organ function instruments | |||
Primary | Disease-free survival and patterns of failure | |||
Primary | Objective tumor response rate (complete and partial response) | |||
Primary | Changes in quality of life | |||
Primary | Correlation of the presence of human papilloma virus infection and p-glycoprotein with outcome |
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