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

Gruppo Oncologico del Nord-Ovest

Status and phase: Unknown; Phase 3

Conditions: Squamous Cell Carcinoma of the Head and Neck

Treatments: Drug: docetaxel - cisplatin - 5-fluorouracil; Radiation: radiotherapy; Drug: cetuximab; Drug: cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00999700

EUDRACT NUMBER 2009-013402-14

Details and patient eligibility

About

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).

Full 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).

Enrollment: 282 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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282 participants in 2 patient groups

ARM A

Experimental group

Description:

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

Treatment:

Radiation: radiotherapy

Drug: cetuximab

Radiation: radiotherapy

Drug: docetaxel - cisplatin - 5-fluorouracil

ARM B

Active Comparator group

Description:

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

Treatment:

Radiation: radiotherapy

Radiation: radiotherapy

Drug: cisplatin