De-intensification of Radiation & Chemotherapy in Low-Risk Human Papillomavirus-related Oropharyn… (NCT01530997) | Clinical Trial Compass
CompletedPhase 2
De-intensification of Radiation & Chemotherapy in Low-Risk Human Papillomavirus-related Oropharyngeal Squamous Cell Ca
United States45 participantsStarted 2012-02-07
Plain-language summary
The purpose of this research study is to learn about the effectiveness of using lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck. The cure rate for this type of cancer is estimated to be high, \> 90%. The standard treatment for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is performed afterwards. This standard regimen causes a lot of side effects and long term complications. This study is evaluating whether a lower dose of radiation and chemotherapy may provide a similar cure rate as the longer, more intensive standard regimen. Patients in this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy followed by a limited surgical evaluation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥ 18 years of age
✓. T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx
✓. Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive
✓. ≤ 10 pack-years smoking history or \> 5 years of abstinence from smoking
✓. History/physical examination within 8 weeks prior to registration
✓. Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration.
✓. The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
✓. Complete Blood Count (CBC)/differential obtained within 4 weeks prior to registration, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl.
Exclusion criteria
✕. Prior history of radiation therapy to the head and neck
What they're measuring
1
Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC).
Timeframe: 6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened
✕. Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are not required for entry into this protocol; Pre-existing ≥ grade 2 neuropathy; Prior organ transplant.
✕. Known HIV positive
✕. Significant pre-existing hearing loss, as defined by the patient or treating physician.