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

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

— INTERCEPTOR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00999700
• Other study ID #: EUDRACT NUMBER 2009-013402-14
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 16, 2009
• Last updated: September 1, 2017
• Start date: September 2009
• Est. completion date: December 2021

Study information

• Verified date: September 2017
• Source: Gruppo Oncologico del Nord-Ovest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 282
• Est. completion date: December 2021
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of the Head and Neck

Intervention

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
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Oncologico del Nord-Ovest

Country where clinical trial is conducted

Italy, 

References & Publications (10)

- A. Forastiere et al., New Engl J Med 2001

- J.P. Pignon et al. Lancet 2000

- Posner M et al, New Engl J Med 2007

- Vermorken J et al, New Engl J Med 2007

Adelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head — View Citation

Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Eng — View Citation

Henke-Gendo C, Schulz TF, Hoeper MM. HHV-8 in pulmonary hypertension. N Engl J Med. 2004 Jan 8;350(2):194-5; author reply 194-5. — View Citation

Lo Nigro C, Maffi M, Fischel JL, Monteverde M, Catarsi P, Tonissi F, Lattanzio L, Riba M, Etienne-Grimaldi MC, Formento P, Milano G, Merlano M. Impact of erythropoietin on the effects of irradiation under hypoxia. J Cancer Res Clin Oncol. 2009 Nov;135(11) — View Citation

Merlano M, Marchetti G. Radiochemotherapy in head and neck cancer. Cancer Treat Rev. 2003 Aug;29(4):291-6. — View Citation

Merlano M. Alternating chemotherapy and radiotherapy in locally advanced head and neck cancer: an alternative? Oncologist. 2006 Feb;11(2):146-51. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		5 years
Secondary	Incidence of acute and late toxicities in the two arms		5 years
Secondary	Progression free survival		5 years
Secondary	Locoregional control		5 years
Secondary	Response rate		5 years

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