NCT00957086

Brief Summary

The aim of the study is to improve the loco-regional control rate and overall survival of locally advanced head and neck squamous carcinoma (HNSCC). The investigators hypothesize that the addition of nimotuzumab (a recombinant humanized murine immune antibody that blocks both epidermal growth factor (EGF) and transforming growth factor (TGF)) to the current gold standard of concurrent chemoradiotherapy (CCRT) (7)(8), an adjuvant setting in patients after resection of their locally advanced HNSCC will confer therapeutic advantage.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
710

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_3

Geographic Reach
13 countries

30 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

August 13, 2009

Completed
15.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

15.4 years

First QC Date

August 11, 2009

Last Update Submit

January 8, 2024

Conditions

Carcinoma, Squamous Cell of Head and Neck

Keywords

Phase III Adjuvant Concurrent Chemo-RT +/- nimotuzumab

Outcome Measures

Primary Outcomes (1)

  • To compare the disease-free survival between patients randomized to adjuvant nimotuzumab/cisplatin/RT with the control arm

    5 years

Secondary Outcomes (2)

  • To compare the overall survival between the two arms

    5 years

  • To assess the Toxicity Profile between the 2 arms

    5 years

Study Arms (2)

Nimotuzumab

ACTIVE COMPARATOR

Comprising Adjuvant Cisplatin, Concurrent RT and Nimotuzumab

Drug: Nimotuzumab

Placebo

PLACEBO COMPARATOR

Comprising Adjuvant Cisplatin, Concurrent RT and Placebo

Drug: Placebo

Interventions

NimotuzumabDRUG

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.

Nimotuzumab
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age should be greater than or equal to the minimum age of consent in the applicable country
  • Histologically proven head and neck squamous cell cancer (excluding nasopharynx, salivary glands, paranasal sinuses and unknown primaries) on biopsy of the primary lesion or the neck mass.
  • Resectable stage III/IV according to the AJCC/UICC staging system with no evidence of distant metastasis.
  • Complete macroscopic resection.
  • Performance status must be ECOG 0 or 1. Patients should be able to tolerate chemotherapy and radiotherapy.
  • Adequate bone marrow, renal and hepatic function:
  • WBC\>3000/mm3, platelets\>100000/mm3
  • Serum creatinine\<upper limit of normal range as per institution and calculated creatinine clearance (according to the Cockcroft and Gault method) \>50 ml/min.
  • SAP, SGOT\<2 x upper limit of normal range, bilirubin \<1.5 x upper limit of normal range.
  • Written informed consent.

You may not qualify if:

  • Histology other than SCC or its subtype.
  • Patients with disease subsite deemed suitable for organ preservation approach, namely stage III/IV laryngeal or hypopharyngeal carcinoma with not more than low-volume T4 disease; low-volume T4 disease is defined as disease not eroding into cartilage or extending not more than 1 cm into the base of tongue.
  • Clinical or radiological evidence of distant metastasis.
  • Uncontrolled comorbidities such as diabetes mellitis, hypertension, cardiac disease.
  • Uncontrolled infection.
  • Uncontrolled hypercalcemia.
  • Prior history of cancer less than 5 years ago or a synchronous primary outside the head and neck area.
  • Prior treatment, head and neck radiotherapy, chemotherapy or surgery (excluding biopsy) or anti-EGFR therapy such as cetuximab/EGFR oral tyrosine kinase inhibitor.
  • Patients for whom compliance with follow-up is unlikely.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Flinders Medical Centre

Bedford Park, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, VIC 3002, Australia

Location

National Institute of Oncology and Radiobiology

Vedado, Cuba

Location

Alexandria University School of Medicine

Alexandria, Egypt

Location

National Cancer Institute, Cairo University

Cairo, Egypt

Location

Apollo Hospital Bangalore

Bangalore, India

Location

Narayana Hrudayalaya Hospital (Mazumdar Shaw Cancer Institute)

Bangalore, India

Location

Amrita Institute of Medical Sciences

Kerala, India

Location

Tata Memorial Centre

Mumbai, India

Location

Christian Medical College

Tamil Nadu, India

Location

Regional Cancer Center Trivandrum, India

Trivandrum, India

Location

Cipto Mangunkusumo General Hospital Indonesia

Jakarta, Indonesia

Location

Pantai Medical Centre, Kuala Lumpur

Kuala Lumpur, Malaysia

Location

Mahkota Medical Center

Malacca, Malaysia

Location

University of Santo Tomas Hospital

Manila, Philippines

Location

St. Luke's Medical Center

Quezon City, Philippines

Location

King Fahad Medical City

Riyadh, Saudi Arabia

Location

National Cancer Centre

Singapore, Singapore

Location

The Oncology Centre

Durban, South Africa

Location

GVI Oncology

Panorama, South Africa

Location

National Cancer Center Korea

Gyeonggi-do, South Korea

Location

INHA University Hospital

Incheon, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taipei Med Univ Hosp [TMUH]

Taipei, Taiwan

Location

Taipei Veteran General Hospital

Taipei, Taiwan

Location

National Cancer Institute Bangkok (+Chulabhorn for RT)

Bangkok, Thailand

Location

Siriraj Hospital

Bangkok, Thailand

Location

Chiang Mai Hospital

Chiang Mai, Thailand

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • K C Soo, Prof

    National Cancer Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 12, 2009

Study Start

August 13, 2009

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

January 9, 2024

Record last verified: 2024-01

Locations

EG(2)IN(6)KR(4)SA(1)CU(1)AU(2)MY(2)PH(2)SG(1)TH(3)TW(3)ID(1)ZA(2)