NCT01953952

Radiation Therapy and Cisplatin With or Without Surgery in Treating Patients With Stage III-IV Oropharyngeal Cancer

Randomized Phase II Trial of Transoral Endoscopic Head And Neck Surgery Followed by Risk-Based IMRT and Weekly Cisplatin Versus IMRT and Weekly Cisplatin for HPV Negative Oropharynx Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies radiation therapy and cisplatin with or without surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without surgery in treating patients with oropharyngeal cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine if primary treatment with transoral endoscopic head and neck surgery will improve progression free survival (PFS) for patients with human papilloma virus negative (HPV-) oropharyngeal cancer (OPC). SECONDARY OBJECTIVES: I. To compare patterns of failure (local-regional relapse versus distant) and survival (overall and progression-free). II. To determine the safety and efficacy (rate of positive surgical margins) of using transoral robotic surgery for patients with T3 tumors of the tonsil, tongue-base, or glossopharyngeal sulcus. III. To compare head and neck cancer-specific quality of life (QOL) short-term (\< 6 months) and long-term (2 years) relating to swallowing function. IV. To compare subjective (patient reported) and objective (physiologic) measures of swallowing function short-term and long-term. V. To assess effect of neck dissection on shoulder function using a validated QOL instrument for patients undergoing neck dissection VI. To assess the correlation of physician derived clinical target volumes (CTV's) with locoregional control or failure. VII. To determine whether specific molecular profiles are associated with overall or progression-free survival or other clinical endpoints. VIII. To determine the sensitivity and specificity of pre-treatment computed tomography (CT) scans detecting the presence of lymph node extracapsular extension by examining the surgically dissected lymph nodes. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo transoral endoscopic head and neck surgery (eHNS). Depending on post-operative pathology findings, patients may undergo intensity modulated radiation therapy (IMRT) once daily (QD) five days a week for 6 weeks. High-risk patients also receive cisplatin intravenously (IV) on days 1, 8, 15, 22, 29, and 36 during radiation therapy. ARM II: Patients undergo IMRT QD five days a week for 7 weeks. Patients also receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 during radiation therapy. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions

• Stage III Squamous Cell Carcinoma of the Oropharynx
• Stage IVA Squamous Cell Carcinoma of the Oropharynx
• Tongue Cancer

Interventions

Type	Name	Description
PROCEDURE	therapeutic conventional surgery	Undergo transoral eHNS
RADIATION	intensity-modulated radiation therapy	Undergo IMRT
DRUG	cisplatin	Given IV
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-10-01
• Last updated: 2015-03-20

Locations

1 site across 1 country: United States