Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck

NCT01427478 | Completed Phase 3 DMC

• 2 other identifiers: BIBW2992 ORL2010-023265-22
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 26

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Afatinib in maintenance therapy after post-operative radiochemotherapy (66 Gy and Cisplatin at the dose of 100mg/m2 every 3 weeks)in squamous cell carcinoma of the head and neck.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and neck squamous cell carcinoma; Post operative radio-chemotherapy; Randomisation; Maintenance treatment; Afatinib

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival 2 years after the end of radiotherapy

  2 years after the end of radiotherapy

Secondary Outcomes (3)

• Safety profile

  Every 28 days during the maintenance therapy,every 2 months during 1 year after maintenance therapy; and every 3 months during the following 3 years

• Quality of life of patient, evaluated by questionnary

  Baseline; at the end of radiotherapy, at 1 and 2 years after the beginning of maintenance treatment

• Overall Survival (OS)

  Death

Study Arms (2)

AFATINIB

EXPERIMENTAL

Radiotherapy combined with a chemotherapy by Cisplatin IV at the dose of 100mg/m2 every 3 weeks, followed by a maintenance therapy with BIBW 2992 for 1 year at the dose of 40 mg/during the 1st month and then 50 mg/d during the 11 following months

Drug: AFATINIB

PLACEBO

PLACEBO COMPARATOR

Radiotherapy associated with a chemotherapy by Cisplatin IV at the dose of 100mg/m2 every 3 weeks, followed by a maintenance therapy with placebo of BIBW 2992 for 1 year at the dose of 40 mg/during the 1st month and then 50 mg/d during the 11 following months

Drug: Placebo of AFATINIB

Interventions

AFATINIB DRUG

AFATINIBat the dose of 40 mg/during the 1st month and then 50 mg/d during the 11 following months

Also known as: BIBW 2992

AFATINIB

Placebo of AFATINIB DRUG

placebo of Afatinib at the dose of 40 mg/during the 1st month and then 50 mg/d during the 11 following months

Also known as: Placebo of BIBW 2992

PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Histologically-confirmed diagnosis of non metastatic squamous-cell carcinoma of oral cavity ; oropharynx, larynx or hypopharynx.
• Macroscopically complete resection of disease.
• High-risk histological features defined as :
• Microscopically incomplete tumour resection and/or invasion of regional lymph nodes with extracapsular extension (pN+R+)
• Indication of radio-chemotherapy (at least 60 Gy of radiotherapy and at least 2 cycles of chemotherapy)
• Start of radio-chemotherapy within 8 weeks after surgery
• Performance Status (PS) ECOG \<= 2
• Hemoglobin \> 9 g/dL Neutrophil count \> 1500 x 109/L Platelets \> 100 x 109/L Total bilirubin \< 1,5x upper limit of normal (ULN) SGOT and SGPT \< 2,5 x ULN Alkaline Phosphatase \< 2,5 xULN Serum creatinine \< 110 µmol/L or creatinine clearance \> 55 ml/min (estimated by Cockcroft Formula) Absence of proteinuria
• Women of childbearing age must use adequate means of contraception(oral hormon contraceptive, intrauterine contraceptive device, double barrier method of contraception).
• Mandatory affiliation with a healthy security insurance.
• Dated and signed written informed consent.

You may not qualify if:

• Macroscopic residual tumour after resection(R2)
• Metastatic disease
• Prior treatment for Head and neck cancer with chemotherapy, radiotherapy or any cancer target therapy
• Prior or concomitant malignancies (except for basal cell skin cancer ; in situ cervical carcinoma or other malignancies with a complete response \> 5 years)
• History of heavy hypersensibility reaction to Cisplatin
• Uncontrolled pulmonary, cardiac , hepatic or renal disease.
• History of interstitial pneumopathy
• Significant cardiovascular disease :
• \- Hepatic affection like : hepatitis B or C chronic advanced decompensated hepatitis hepatitic cirrhosis or newly treated chronic hepatitis or nowadays treated with immunosuppressive drugs severe auto-immune hepatitis or disease
• HIV known history
• Recent digestive symptoms with diarrhea as :
• Crohn's disease malabsorption syndrome diarrhea Grade CTC ≥ 2
• Active drug or alcohol use or dependence
• Pregnant or breast-feeding women , or no use of effective birth control methods for women of childbearing potential, , or men who don't accept to use an effective birth control methods during the study
• Impossible follow-up

Sponsors & Collaborators

• Centre Leon Berard: lead
• Boehringer Ingelheim: collaborator

Study Sites (26)

Centre Paul Papin

Angers, 49933, France

Location

Institut Sainte-Catherine

Avignon, 84000, France

Location

CHU Bordeaux - Hôpital Saint-André

Bordeaux, 33075, France

Location

Polyclinique de Bordeaux Nord

Bordeaux, 33300, France

Location

CHRU Brest - Hôpital Morvan

Brest, 29609, France

Location

Centre François Baclesse

Caen, 14076, France

Location

CHIC Créteil

Créteil, 94010, France

Location

Centre Guillaume le Conquérant

Le Havre, 76600, France

Location

Centre Hospitalier Bretagne Sud

Lorient, 56100, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

AP-HM La Timone Adultes

Marseille, 13386 Cedex, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Centre Eugène Marquis

Rennes, 44229, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

Location

Pôle Hospitalier Mutualiste- Centre Etienne Dolet

Saint-Nazaire, 44600, France

Location

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Strasbourg Oncologie Libérale

Strasbourg, 67000, France

Location

Hopitaux du Léman

Thonon-les-Bains, 74203, France

Location

Clinique Pasteur Bâtiment l'Atrium

Toulouse, 31076, France

Location

Institut Claudius Regaud

Toulouse, 71000, France

Location

CHU TOURS (Hôpital Bretonneau)

Tours, 37044, France

Location

Centre de Radiothérapie Marie Curie

Valence, 26000, France

Location

Institut de Cancérologie de lorraine (ICL)

Vandœuvre-lès-Nancy, 54519 cedex, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (17)

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  PMID: 36434888 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Séverine RACADOT, MD

  Centre Léon Bérard, Lyon

  PRINCIPAL INVESTIGATOR

• Pascal POMMIER, MD

  Centre Léon Bérard, Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 1, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2020
• Study Completion: May 1, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-05

Locations

FR (26)