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e17511 Background: Both Dose escalation and acceleration can achieve higher tumor control rates with uncertain role of addition of concurrent chemotherapy. We aimed at developing a protocol for patients unable to receive the standard CCRT with little toxicity profile. Toxicity and Quality of life assessment were our primary end points in this pilot phase II trial. It is known from literature that pre-treatment QOL affects survival. Also, changes in QOL after treatment predict survival in cancer patients. Methods: 63 locally advanced HNC patients were randomized to receive (Arm A) 70Gy/35fr/7wks at 2Gy/fx concurrently with weekly Cisplatin 40mg/m2 or to receive (Arm B) 74Gy/33fx/6.5wks at 2.24Gy/fx with calculation of the Biological equivalent doses. CTCEA v4.3 was used to assess toxicity and Functional Assessment Cancer Therapy-Head & Neck (FACT-H&N) questionnaire (39-item) was used to assess QOL. The Questionnaires were collected and their scorings were calculated to get the FACT-H&N Trial outcome index (TOI), FACT-G and FACT-H&N total score pre-radiotherapy, 3 and 6 months post-radiotherapy for each patient. Results: There were 33 patients in arm A vs. 30 patients in arm B with median follow up 24.2 months. Our results showed statistical significant decrease of chemotherapy related toxicities (nausea, vomiting, neutropenia and anemia), acute (mucositis, oral pain, voice alteration, fatigue and acute dysphagia) and some late toxicities (late xerostomia) in the investigational arm vs. the CCRT arm. Regarding the FACT QOL assessment and scorings of the different parameters, there was no statistical difference between both arms in all FACT-H&N TOI, FACT-G and FACT-H&N total scores at pre-treatment, 3 and 6 months post treatment. Also when analyzing the mean change with time across the two groups pre-radiotherapy, 3 and 6 months post radiotherapy, it was not statistically significant. Our results did not demonstrate any significant differences in 2-year disease local control, PFS and OS between both arms, with comparable patterns of relapse. Conclusions: Slightly dose escalated hypofractionated regimen could be an option in LA-HNC treatment without affecting QOL, which needs confirmation in prospective large multi-centric trials. Clinical trial information: NCT03699969.

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