Phase 2
N=45
De-intensification of Radiation & Chemotherapy in Low-Risk Human Papillomavirus-related Oropharyngeal Squamous Cell Ca
Carcinoma, Squamous Cell · Head and Neck Neoplasms · Oropharyngeal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01530997 ↗Enrolled (actual)
45
Serious AEs
33.3%
Results posted
Aug 2017
Primary outcome: Primary: Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC). — 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intensity Modulated Radiotherapy (IMRT) (Radiation); Cisplatin (Drug); Limited surgical evaluation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC). |
37 | — |
| SECONDARY Two-Year Local Control |
100 | — |
| SECONDARY Regional Control |
100 | — |
| SECONDARY Cause-Specific Survival |
100 | — |
| SECONDARY Distant Metastases Free Survival |
100 | — |
| SECONDARY Overall Survival Rate |
95 | — |
| SECONDARY European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 |
19; 25; 26; 11; 19; 18 | — |
| SECONDARY European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL |
80; 61; 69; 96; 78; 85 | — |
| SECONDARY The Eating Assessment Tool (EAT-10) Composite Score |
4; 13; 11 | — |
| SECONDARY The Rosenbek Penetration Aspiration Scale |
1.30; 1.90; 1.03; 1.19; 1.03; 1.03 | — |
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.
Eligibility Criteria
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.
- Adequate renal and hepatic function within 4 weeks prior to registration, defined as follows: Serum creatinine < 2.0 mg/dl; Total bilirubin < 2 x the institutional upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN.
- Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
- Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.
- Patients must be deemed able to comply with the treatment plan and follow-up schedule.
- Patients must provide study specific informed consent prior to study entry.
Exclusion Criteria
- Prior history of radiation therapy to the head and neck
- Prior history of head and neck cancer.
- 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.
Data sourced from ClinicalTrials.gov (NCT01530997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.