Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin (INTERCEPTOR)

September 1, 2017 updated by: MARCO MERLANO, Gruppo Oncologico del Nord-Ovest
A phase III trial of induction chemotherapy followed by definitive radiotherapy plus Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of the head and neck (HNC).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The objective of this trial is to determine whether Cetuximab and radiation preceded by an induction chemotherapy, may be superior to an established chemoradiation program for HNC (RTOG regimen, Adelstein DJ J.Clin.Oncol. 2003;21:92-98).

Study Type

Interventional

Enrollment (Anticipated)

282

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • Ospedale Civile Ss. Antonio E Biagio
      • Aosta, Italy
        • Ausl Della Valle D' Aosta
      • Bologna, Italy
        • Policlinico S. Orsola-Malpighi
      • Cagliari, Italy
        • Asl 8 - Ospedale Businco
      • Cuneo, Italy, 12100
        • A.S.O. S. Croce E Carle
      • Genoa, Italy
        • Irccs - Aou S. Martino - Oncology
      • Genoa, Italy
        • Irccs - Aou San Martino - Radiotherapy
      • Genova, Italy
        • E.O. Ospedali Galliera
      • Genova, Italy
        • ASL 3 Genovese
      • Italy, Italy
        • Azienda Ospedaliera Villa Scassi - Asl3
      • Milano, Italy
        • Istituto Nazionale dei Tumori
      • Modena, Italy
        • Azienda Ospedaliero Universitaria di Modena
      • Novi Ligure (al), Italy
        • Ospedale S. Giacomo
      • Parma, Italy
        • Azienda Ospedaliero-Universitaria di Parma
      • Pesaro, Italy
        • Azienda Ospedaliera Ospedali Riuniti Di Fano
      • Reggio Emilia, Italy
        • Arcispedale S. Maria Nuova
      • Rionero in Vulture (pz), Italy
        • Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
      • Roma, Italy
        • Ospedale S. Filippo Neri
      • Savona, Italy
        • Ospedale S. Paolo
      • Turin, Italy
        • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Torino (to)
      • Turin, Italy
        • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • > 18 years of age
  • Histologically or cytologically confirmed diagnosis of HNSCC
  • Stage III/IV, not suitable for surgery (definitive cure rate improbable, technically unresectable or medical contraindication for surgery)
  • At least one uni-dimensional measurable lesion either by CT scan or MRI
  • Signed written informed consents prior to beginning protocol

Specific procedures:

  • Tumor tissue available for immunohistochemical staining of EGFR expression and HPV
  • Life expectancy of > 3 months at study entry
  • ECOG Performance Status of <2 at study entry.
  • Effective contraception if risk of conception exists.
  • Neutrophils > 2.0/mm³, platelet count > 100,000/mm³, and hemoglobin > 10 g/dl
  • Normal liver function
  • Serum creatinine > 1.25 x ULN and/or creatinine clearance > 60 ml/min

Exclusion Criteria:

  • Prior systemic chemotherapy and/or radiotherapy
  • Known peripheral neuropathy > grade 2 NCI-CTC version 3.0
  • Known chronic heart failure
  • Prior surgery, excluding prior diagnostic biopsy
  • Known drug abuse
  • Active uncontrolled infection
  • Other concomitant anticancer therapy
  • Distant metastasis
  • Concurrent chronic systemic immune therapy, chemotherapy for disease other than cancer, or hormone therapy not indicated in the study protocol
  • Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months before study entry
  • Medical or psychological condition that would not permit the patient to complete the trial or sign informed consent
  • Nasopharyngeal carcinoma WHO type II or III
  • Known allergic reaction against any of the components of the treatment
  • Pregnancy (absence confirmed by beta-HCG test) or lactation period
  • Any prior or on-going investigational medication
  • Previous or current malignancy except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARM A
Induction chemotherapy: TCF (Vermorken, N Eng J Med 2007) Definitive treatment: RT + C-mab (Bonner, N Eng J Med 2006)
Drug: docetaxel - cisplatin - 5-fluorouracil
docetaxel 75 mg/sqm day1 cisplatin 75 mg/sqm day1 5-fluorouracil 750 mg/sqm/d c.i. day1 to day4 q21
Radiation: radiotherapy

Conformal radiotherapy or IMRT should be employed.

Standard radiotherapy:

Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.

Drug: cetuximab
400 mg/sqm at the 1st infusion - before starting RT 250 mg/sqm weekly - concurrent with RT up to the last week of treatment
Active Comparator: ARM B
RT + Cddp (RTOG, Adelstein, J Clin Oncol 2003)
Radiation: radiotherapy

Conformal radiotherapy or IMRT should be employed.

Standard radiotherapy:

Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.

Drug: cisplatin
Cisplatin, 100 mg/sqm every 3 weeks, three times, concurrent with RT, starting from day 1 of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: 5 years
5 years
Progression free survival
Time Frame: 5 years
5 years
Incidence of acute and late toxicities in the two arms
Time Frame: 5 years
5 years
Locoregional control
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Oncologico del Nord-Ovest

Investigators

  • Principal Investigator: MARCO MERLANO, MD, ASCO, ESMO, AIOM, G.O.N.O.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 31, 2016

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

October 16, 2009

First Submitted That Met QC Criteria

October 21, 2009

First Posted (Estimate)

October 22, 2009

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUDRACT NUMBER 2009-013402-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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