search
Back to results

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

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
docetaxel - cisplatin - 5-fluorouracil
radiotherapy
cetuximab
cisplatin
radiotherapy
Sponsored by
Gruppo Oncologico del Nord-Ovest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck focused on measuring Locally advanced HNSCC, Chemo-radiation, Induction chemotherapy, Stage III/IV, Unresectable disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Civile Ss. Antonio E Biagio
  • Ausl Della Valle D' Aosta
  • Policlinico S. Orsola-Malpighi
  • Asl 8 - Ospedale Businco
  • A.S.O. S. Croce E Carle
  • Irccs - Aou S. Martino - Oncology
  • Irccs - Aou San Martino - Radiotherapy
  • Asl 3 Genovese
  • E.O. Ospedali Galliera
  • Azienda Ospedaliera Villa Scassi - Asl3
  • Istituto Nazionale Dei Tumori
  • Azienda Ospedaliero Universitaria Di Modena
  • Ospedale S. Giacomo
  • Azienda Ospedaliero-Universitaria Di Parma
  • Azienda Ospedaliera Ospedali Riuniti Di Fano
  • Arcispedale S. Maria Nuova
  • Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
  • Ospedale S. Filippo Neri
  • Ospedale S. Paolo
  • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Torino (to)
  • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ARM A

ARM B

Arm Description

Induction chemotherapy: TCF (Vermorken, N Eng J Med 2007) Definitive treatment: RT + C-mab (Bonner, N Eng J Med 2006)

RT + Cddp (RTOG, Adelstein, J Clin Oncol 2003)

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Incidence of acute and late toxicities in the two arms
Progression free survival
Locoregional control
Response rate

Full Information

First Posted
October 16, 2009
Last Updated
September 1, 2017
Sponsor
Gruppo Oncologico del Nord-Ovest
search

1. Study Identification

Unique Protocol Identification Number
NCT00999700
Brief Title
Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
Acronym
INTERCEPTOR
Official Title
Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gruppo Oncologico del Nord-Ovest

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck
Keywords
Locally advanced HNSCC, Chemo-radiation, Induction chemotherapy, Stage III/IV, Unresectable disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARM A
Arm Type
Experimental
Arm Description
Induction chemotherapy: TCF (Vermorken, N Eng J Med 2007) Definitive treatment: RT + C-mab (Bonner, N Eng J Med 2006)
Arm Title
ARM B
Arm Type
Active Comparator
Arm Description
RT + Cddp (RTOG, Adelstein, J Clin Oncol 2003)
Intervention Type
Drug
Intervention Name(s)
docetaxel - cisplatin - 5-fluorouracil
Intervention Description
docetaxel 75 mg/sqm day1 cisplatin 75 mg/sqm day1 5-fluorouracil 750 mg/sqm/d c.i. day1 to day4 q21
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
Conformal radiotherapy or IMRT should be employed. Standard radiotherapy: Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.
Intervention Type
Drug
Intervention Name(s)
cetuximab
Intervention Description
400 mg/sqm at the 1st infusion - before starting RT 250 mg/sqm weekly - concurrent with RT up to the last week of treatment
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Cisplatin, 100 mg/sqm every 3 weeks, three times, concurrent with RT, starting from day 1 of treatment.
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
Conformal radiotherapy or IMRT should be employed. Standard radiotherapy: Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Incidence of acute and late toxicities in the two arms
Time Frame
5 years
Title
Progression free survival
Time Frame
5 years
Title
Locoregional control
Time Frame
5 years
Title
Response rate
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARCO MERLANO, MD
Organizational Affiliation
ASCO, ESMO, AIOM, G.O.N.O.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Civile Ss. Antonio E Biagio
City
Alessandria
Country
Italy
Facility Name
Ausl Della Valle D' Aosta
City
Aosta
Country
Italy
Facility Name
Policlinico S. Orsola-Malpighi
City
Bologna
Country
Italy
Facility Name
Asl 8 - Ospedale Businco
City
Cagliari
Country
Italy
Facility Name
A.S.O. S. Croce E Carle
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Irccs - Aou S. Martino - Oncology
City
Genoa
Country
Italy
Facility Name
Irccs - Aou San Martino - Radiotherapy
City
Genoa
Country
Italy
Facility Name
Asl 3 Genovese
City
Genova
Country
Italy
Facility Name
E.O. Ospedali Galliera
City
Genova
Country
Italy
Facility Name
Azienda Ospedaliera Villa Scassi - Asl3
City
Italy
Country
Italy
Facility Name
Istituto Nazionale Dei Tumori
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Di Modena
City
Modena
Country
Italy
Facility Name
Ospedale S. Giacomo
City
Novi Ligure (al)
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Di Parma
City
Parma
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Di Fano
City
Pesaro
Country
Italy
Facility Name
Arcispedale S. Maria Nuova
City
Reggio Emilia
Country
Italy
Facility Name
Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
City
Rionero in Vulture (pz)
Country
Italy
Facility Name
Ospedale S. Filippo Neri
City
Roma
Country
Italy
Facility Name
Ospedale S. Paolo
City
Savona
Country
Italy
Facility Name
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Torino (to)
City
Turin
Country
Italy
Facility Name
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino
City
Turin
Country
Italy

12. IPD Sharing Statement

Citations:
Citation
- J.P. Pignon et al. Lancet 2000
Results Reference
result
Citation
- A. Forastiere et al., New Engl J Med 2001
Results Reference
result
Citation
- Adelstein DJ J.Clin.Oncol. 2003
Results Reference
result
Citation
- Henke, New England 2004
Results Reference
result
Citation
- J.A. Bonner et al., New Engl J Med 2006
Results Reference
result
PubMed Identifier
16476835
Citation
Merlano M. Alternating chemotherapy and radiotherapy in locally advanced head and neck cancer: an alternative? Oncologist. 2006 Feb;11(2):146-51. doi: 10.1634/theoncologist.11-2-146.
Results Reference
result
Citation
- Posner M et al, New Engl J Med 2007
Results Reference
result
Citation
- Vermorken J et al, New Engl J Med 2007
Results Reference
result
Citation
- Lo Nigro, Journal of Cancer Research Clinical Oncology 2009
Results Reference
result
PubMed Identifier
12927569
Citation
Merlano M, Marchetti G. Radiochemotherapy in head and neck cancer. Cancer Treat Rev. 2003 Aug;29(4):291-6. doi: 10.1016/s0305-7372(03)00022-7.
Results Reference
result
Links:
URL
http://www.reteoncologica.it/
Description
click on "trials" for more informations

Learn more about this trial

Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin

We'll reach out to this number within 24 hrs