Abstract 3961
Background
LA-HNSCC is treated with concurrent chemo-radiation. Majority of guidelines recommend bolus Cisplatin in the dose of 100 mg/m2 (on days 1, 22, and 43). The meta-analysis reported by MACH-NC group found a greater benefit for platinum-based chemotherapy as compared with other protocols. Multiple studies back this notion. Other options are weekly cisplatin (30-40 mg/m2) or split course radiation and combination of DDP+5FU. Alternative dosing schedules (e.g., 30 to 40 mg/m2 weekly, 6 mg/m2 daily, or 20 mg/m2 daily for five days weeks 1 and 5) are used because of improved patient tolerance and ease of administration. 30 mg/m2 of weekly cisplatin has found to be inferior to 3 weekly 100 mg/m2. Three weekly schedules is the benchmark for further trials. In practice many of physicians alternatively, use low dose. 40 mg/m2 has been found superior to RT alone in a phase II randomized study. Whether 40 mg/m2 weekly cisplatin is inferior to 100 mg/m2 is not known. Based on our previous report and our long experience we are quite comfortable with weekly Cisplatin (in the dose of 40 mg/m2), and hypothesize that weekly Cisplatin (40 mg/m2) times 6-7 is non-inferior to 3 weekly Cisplatin 100 mg/m2 times three (days 1,22,43).
Trial design
Multicentric Open labelled, non-inferiority randomized controlled phase III trial. Sample size was calculated expecting 60% LRC (loco-regional control) rate at 2 years in control arm, and 65% in experimental arm, with 80%power of study, alpha error 5%, non-inferiority margin of 10%. Based on these parameters each arm will require143 patients (including 10% lost to follow up/protocol violations etc.). Main Inclusion criteria: Newly diagnosed, chemo/radiotherapy naïve, biopsy or cytology proven, locally advanced head and neck squamous cell carcinoma excluding nasopharyngeal carcinoma (stage III and IV without distant metastases). ARM A: Three weekly Cisplatin100 mg/m2 (Day1, 22, 43) to be started on first day of radiation and given on days 1,22,43 ARM B: Weekly Cisplatin40mg/m2 times 6-7 Primary objective: Loco Regional Control Rate at 2 years.
Clinical trial identification
CTRI/2018/03/012422 release date 08/03/2018.
Editorial acknowledgement
Legal entity responsible for the study
Atul Sharma.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5822 - Greek nursing students experience facing death in clinical practice
Presenter: Maria Dimoula
Session: Poster Display session 3
Resources:
Abstract
2866 - HOPEVOL: Hospice care appropriate to the wishes and needs of patients in the palliative terminal phase.
Presenter: Merel van Klinken
Session: Poster Display session 3
Resources:
Abstract
829 - Mindfulness-based stress reduction in early palliative care for advanced cancer patients : an italian single-centre study. MINDEEP
Presenter: Emilia Gianotti
Session: Poster Display session 3
Resources:
Abstract
2702 - Optimising Inpatient Oncology Care
Presenter: Lisa Judge
Session: Poster Display session 3
Resources:
Abstract
1527 - Analysis on the Implementation Results of Family Sickbed for Oncology Patients in Dongshi Township Health Centers from 2015 to 2017
Presenter: Yayu Huang
Session: Poster Display session 3
Resources:
Abstract
2054 - Exploring needs for palliative care and quality of life for oncology patients with advanced disease who undergo radiotherapy
Presenter: Foteini Antonopoulou
Session: Poster Display session 3
Resources:
Abstract
5605 - Cytotoxic contamination in cancer care settings – Risks and safety awareness among cancer nurses
Presenter: Sandra Lundman Vikberg
Session: Poster Display session 3
Resources:
Abstract
5769 - Understanding Chemotherapy - group education sessions prior to commencing chemotherapy
Presenter: Aileen McHale
Session: Poster Display session 3
Resources:
Abstract
2620 - Estimation of HPQ-based absenteeism and presenteeism in cancer patients via ResearchKit
Presenter: Shunsuke Kondo
Session: Poster Display session 3
Resources:
Abstract
4705 - Identifying falls-related variables and risk factors in hospitalised cancer patients
Presenter: Maria Montserrat Martí Dillet
Session: Poster Display session 3
Resources:
Abstract