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Poster Display session 3

3961 - Concurrent Chemotherapy and External Radiation Therapy: An Open Label Non-Inferiority Phase III Randomized Controlled Trial of Weekly versus Three Weekly Cisplatin and Radical Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: CONCERT trial

Date

30 Sep 2019

Session

Poster Display session 3

Topics

Tumour Site

Head and Neck Cancers

Presenters

ATUL SHARMA

Citation

Annals of Oncology (2019) 30 (suppl_5): v449-v474. 10.1093/annonc/mdz252

Authors

A. SHARMA1, M.K. CHAUDHARY2, A. Thakar3, S. Bhaskar4, K. Sikka3, R. Pramanik1, A. Biswas4, C.A. Singh3, R.K. Sahoo5, S. Deo6, R. Kumar3, S. Thulkar7, A. Kakkar8, S. Seth9, V. SREENIVAS10

Author affiliations

  • 1 Medical Oncology, B.R. Ambedkar Institute Rotary Cancer Hospital (AIIMS), 110029 - Delhi/IN
  • 2 Research And Referral, Army Hospital, 110010 - New Delhi/IN
  • 3 Oto-laryngology And Head & Neck Surgery, B.R. Ambedkar Institute Rotary Cancer Hospital (AIIMS), 110029 - Delhi/IN
  • 4 Radiation Oncology, B.R. Ambedkar Institute Rotary Cancer Hospital (AIIMS), 110029 - Delhi/IN
  • 5 Medical Oncology, B.R. Ambedkar Institute Rotary Cancer Hospital (AIIMS), 110029 - New Delhi/IN
  • 6 Surgical Oncology, B.R. Ambedkar Institute Rotary Cancer Hospital (AIIMS), 110029 - New Delhi/IN
  • 7 Radiology, B.R. Ambedkar Institute Rotary Cancer Hospital (AIIMS), 110029 - Delhi/IN
  • 8 Pathology, All India Institute of Medical Sciences, 110029 - Delhi/IN
  • 9 Cardiology, All India Institute of Medical Sciences, 110029 - Delhi/IN
  • 10 Biostatistics, B.R. Ambedkar Institute Rotary Cancer Hospital (AIMS), 110029 - New Delhi/IN

Resources

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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.

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