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NCT05648461
Phase II Study Exploring Five Fractions of Post-operative Radiation Therapy in Head and Neck Cancer
Conditions: Head and Neck Cancer
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 50
Sponsor: All India Institute of Medical Sciences, New Delhi
Location: India
Summary
The purpose of this research study is to investigate a shorter radiation treatment schedule for head and neck cancers.
The present study is a non -randomized phase II study that will enroll 50 patients and test feasibility of 30 Gy in 5 fractions of the primary disease and ipsilateral level I-III disease.
Eligibility Criteria
Inclusion Criteria:Aged 18 or above and less than 80 years.Patient with high risk features: close (≤ 5mm) margin, presence of LVI or PNI, pT3-4.Stage pT1-4 histological confirmed carcinoma of oral cavity with intermediate high risk feature.Pathological N0 neck requiring ipsilateral neck PORT.Karnofsky performance score greater or equal 70.Timely delivery of PORT preferable within 6-12 weeks of surgery (additional delay of 1-3 weeks of delay beyond 12 weeks is permissible to accommodate for delayed wound healing or other logistics).Written informed consent for treatment.Available to attend long term follow- up.Exclusion Criteria:Pathologically positive neck disease.Positive margin.Patients requiring bilateral neck RT.Patients that require re-irradiation for recurrent disease.Previous radiotherapy to the head and neck region.Any invasive malignancy within the previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).Age < 18 years or > 80 years.
Source: ClinicalTrials.gov (NCT05648461). StuddyBuddy aggregates publicly available trial information.