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

This study is currently recruiting participants.
Verified December 2013 by Gruppo Oncologico del Nord-Ovest
Sponsor:
Information provided by (Responsible Party):
MARCO MERLANO, Gruppo Oncologico del Nord-Ovest
ClinicalTrials.gov Identifier:
NCT00999700
First received: October 16, 2009
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Squamous Cell Carcinoma of the Head and Neck
Drug: docetaxel - cisplatin - 5-fluorouracil
Radiation: radiotherapy
Drug: cetuximab
Drug: cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin

Resource links provided by NLM:


Further study details as provided by Gruppo Oncologico del Nord-Ovest:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of acute and late toxicities in the two arms [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Locoregional control [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 278
Study Start Date: September 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: cisplatin
Cisplatin, 100 mg/sqm every 3 weeks, three times, concurrent with RT, starting from day 1 of treatment.
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.


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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999700

Contacts
Contact: MARCO MERLANO, PRINCIPAL INVESTIGATOR +390171616739 ext 6739 MERLANO.M@OSPEDALE.CUNEO.IT
Contact: IDA COLANTONIO, CO-INVESTIGATOR +390171616739 ext 6739 COLANTONIO.I@OSPEDALE.CUNEO.IT

Locations
Italy
A.S.O. S. Croce E Carle Recruiting
Cuneo, Italy, 12100
Contact: MARCO MERLANO, PRINCIPAL INVESTIGATOR    +390171616739 ext 6739    MERLANO.M@OSPEDALE.CUNEO.IT   
Contact: IDA COLANTONIO, CO-INVESTIGATOR    +390171616739 ext 6739    COLANTONIO.I@OSPEDALE.CUNEO.IT   
Sponsors and Collaborators
Gruppo Oncologico del Nord-Ovest
Investigators
Principal Investigator: MARCO MERLANO, PRINCIPAL INVESTIGATOR ASCO, ESMO, AIOM, G.O.N.O.
  More Information

Additional Information:
No publications provided

Responsible Party: MARCO MERLANO, MD, Gruppo Oncologico del Nord-Ovest
ClinicalTrials.gov Identifier: NCT00999700     History of Changes
Other Study ID Numbers: EUDRACT NUMBER 2009-013402-14
Study First Received: October 16, 2009
Last Updated: December 11, 2013
Health Authority: Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Gruppo Oncologico del Nord-Ovest:
Locally advanced HNSCC
Chemo-radiation
Induction chemotherapy
Stage III/IV
Unresectable disease

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Cetuximab
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014