Study of Chemotherapy Prior to Radiotherapy and Chemotherapy in Patients With HPV Associated Cancer of the Oral Cavity
This study looks at the use of three cycles of chemotherapy given prior to radiation therapy in patients with cancer of the oral cavity and evidence of prior exposure to Human Papilloma Virus (HPV). Patients with cancer of the oral cavity who have evidence of exposure to HPV have a better prognosis than those who do not have such evidence of exposure to HPV. The main hypothesis of this study is that using three cycles of chemotherapy prior to embarking on radiation therapy will allow the use of reduced doses of radiation therapy and, therefore, less radiation induced side-effects. The primary objective is to determine the activity of this pre-radiation chemotherapy strategy along with reduced dose levels of radiation with or without chemotherapy during the radiation phase. The effectiveness of the strategy will be assessed at three months following the completion of the radiation therapy phase and also at two years following completion of the radiation therapy.
Radiation: Reduced dose radiotherapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Neoadjuvant Chemotherapy for HPV-Associated Squamous Cell Carcinoma of the Oropharynx Followed by Reduced Dose Radiotherapy/Chemoradiotherapy for Responders or Standard Dose Chemoradiotherapy for Non-Responders|
- Response (CR+PR) Status at 3 Months Post-therapy [ Time Frame: 3 months following completion of radiation phase ] [ Designated as safety issue: No ]
The 3-month response rate will be estimated using standard methods for estimating proportions and their 95% one-sided confidence intervals (CIs). Comparison to the historical control data will be carried out using a chi-square test for comparing proportions (or a Fisher exact test if an expected cell frequency in the 2x2 table is less than 5).
Zero (0) participants analyzed
- To Define Objective Tumor Response Rates to Induction Chemotherapy and to Subsequent Radiation-based Treatment. [ Time Frame: Three months following completion of radiation therapy phase. ] [ Designated as safety issue: No ]To define objective tumor response rates to induction chemotherapy and to subsequent radiation-based treatment, per RESIST version 1.1 criteria.
- Progression-free Survival at 2 Years [ Time Frame: At two years following completion of radiation phase ] [ Designated as safety issue: No ]assess Progression-free survival at 2 years.
- Assess Overall Survival at 2 Years. [ Time Frame: At two years following completion of radiation phase ] [ Designated as safety issue: No ]To assess overall survival at 2 years.
- Assess Locoregional Disease Control at 2 Years [ Time Frame: At two years following completion of radiation phase ] [ Designated as safety issue: No ]To assess locoregional disease control at 2 years
- Assess Distant Disease Control at 2 Years. [ Time Frame: At two years following completion of radiation phase ] [ Designated as safety issue: No ]3.5 To assess distant disease control at 2 years.
- Assessment of Quality of Life Outcomes [ Time Frame: Baseline, during therapy and up to two years following completion of radiation phase ] [ Designated as safety issue: No ]Serial evaluation of functional quality-of-life, including M. D. Anderson Dysphagia Inventory (MDADI) and Oropharyngeal swallowing efficiency (OPSE) measures of swallowing function, as well as formal sialometric measurement of parotid function.
- Identify Additional Toxicity of Treatment [ Time Frame: During therapy and up to 5 years following completion of treatment ] [ Designated as safety issue: Yes ]To identify additional toxicity of treatment
|Study Start Date:||August 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Chemotherapy non-responders
Patients treated with three cycles neoadjuvant chemotherapy who do not exhibit response to chemotherapy are then allocated to recieve standard dose and schedule radiotherapy.
Chemotherapy for three cycles prior to radiotherapy
Other Name: Cisplatin, Carboplatin, Flourouracil, EtoposideRadiation: radiotherapy
Standard radiotherapy for non-responders vs reduced dose radiotherapy for responders.
Other Name: IMRT, Radiation Therapy
Experimental: Chemotherapy responders
Patients who respond to chemotherapy are treated with reduced dose radiotherapy.
Chemotherapy for three cycles prior to radiotherapy
Other Name: Cisplatin, Carboplatin, Flourouracil, EtoposideRadiation: Reduced dose radiotherapy
Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy.
Other Name: IMRT, Reduced dose radiation therapy
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525927
|United States, New York|
|Long Island Jewish Medical Center|
|New Hyde Park, New York, United States, 11040|
|Principal Investigator:||Bhoomi Mehrotra, MD||North Shore-LIJ Health System|