Study of Post-Op Adjuvant Concurrent Chemo-RT With or Without Nimotuzumab for Head & Neck Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

710

Participants

Timeline

Start Date

August 13, 2009

Primary Completion Date

January 1, 2025

Study Completion Date

January 1, 2025

Conditions
Carcinoma, Squamous Cell of Head and Neck
Interventions
DRUG

Nimotuzumab

Administered by intravenous infusion at 200 mg absolute per dose, diluted in 250 ml of sodium chloride over 30 minutes. 8 weekly doses of study drug will be given, beginning on first week of radiotherapy.

DRUG

Placebo

Administered by intravenous infusion at 200 mg absolute per dose, diluted in 250 ml of sodium chloride over 30 minutes. 8 weekly doses of study drug will be given, beginning on first week of radiotherapy.

Trial Locations (30)

Unknown

Flinders Medical Centre, Bedford Park

National Institute of Oncology and Radiobiology, Vedado

Alexandria University School of Medicine, Alexandria

National Cancer Institute, Cairo University, Cairo

Apollo Hospital Bangalore, Bangalore

Narayana Hrudayalaya Hospital (Mazumdar Shaw Cancer Institute), Bangalore

Amrita Institute of Medical Sciences, Kerala

Tata Memorial Centre, Mumbai

Christian Medical College, Tamil Nadu

Regional Cancer Center Trivandrum, India, Trivandrum

Cipto Mangunkusumo General Hospital Indonesia, Jakarta

Pantai Medical Centre, Kuala Lumpur, Kuala Lumpur

Mahkota Medical Center, Malacca

University of Santo Tomas Hospital, Manila

St. Luke's Medical Center, Quezon City

King Fahad Medical City, Riyadh

National Cancer Centre, Singapore

The Oncology Centre, Durban

GVI Oncology, Panorama

National Cancer Center Korea, Gyeonggi-do

INHA University Hospital, Incheon

Samsung Medical Center, Seoul

Severance Hospital, Yonsei University Health System, Seoul

China Medical University Hospital, Taichung

Taipei Med Univ Hosp [TMUH], Taipei

Taipei Veteran General Hospital, Taipei

National Cancer Institute Bangkok (+Chulabhorn for RT), Bangkok

Siriraj Hospital, Bangkok

Chiang Mai Hospital, Chiang Mai

VIC 3002

Peter MacCallum Cancer Centre, Melbourne

Sponsors
All Listed Sponsors
collaborator

National Medical Research Council (NMRC), Singapore

OTHER_GOV

collaborator

Innogene Kalbiotech Pte. Ltd

INDUSTRY

lead

National Cancer Centre, Singapore

OTHER