Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers

NCT00828386 | Terminated Phase 3

• 1 other identifier: GORTEC NPC2006
• Study Type: interventional
• Target: 83
• Locations: 4 countries
• Sites: 5

Brief Summary

This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival.

Conditions

Nasopharyngeal Cancers

Keywords

Nasopharyngeal cancers; induction chemotherapy; radiochemotherapy

Outcome Measures

Primary Outcomes (1)

• Event free-survival

  3 years

Secondary Outcomes (6)

• Survival

  3 years

• late and acute toxicity according to NCI-CTC and EORTC/RTOG criteria

  early and late

• Cumulative incidence of loco-regional progression

  3 years

• Cumulative rate of metastasis

  3 years

• Global response to chemo-radiotherapy

  3 years

Study Arms (2)

Induction chemotherapy + concurrent chemoradiotherapy

EXPERIMENTAL

Induction chemotherapy (Docetaxel + Cisplatin + 5-FU): * Docetaxel 75 mg/m² administered on D1 of each course, every 3 weeks, via one-hour IV infusion * Cisplatin 75 mg/m² administered on D1 via one-hour infusion followed by * 5-Fluorouracil (as a continuous infusion): 750 mg/m²/d administered as a continuous infusion from D1 to D5. The cycles will be repeated every 3 weeks up to a total of 3 courses. Followed by concurrent chemoradiotherapy with Cisplatin : weekly Cisplatin 40 mg/m2 starting on D1 of the radiation therapy (70 Gy/7 weeks).

Procedure: Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy

Concurrent radiochemotherapy alone

ACTIVE COMPARATOR

Concurrent chemoradiotherapy with Cisplatin : weekly Cisplatin 40 mg/m2 starting on D1 of the radiation therapy (70 Gy/7 weeks).

Procedure: Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy

Interventions

Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy PROCEDURE

Induction chemotherapy (Docetaxel, Cisplatin and 5-Fluorouracil) + concurrent radiochemotherapy

Concurrent radiochemotherapy alone; Induction chemotherapy + concurrent chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• WHO II-III carcinoma of the nasopharynx, histologically proven by a nasal cavity biopsy, locally advanced T2b, T3, T4 and/or N1, N2 or N3 (UICC/AJCC2002).
• Absence of distant metastases, confirmed by a chest CT scan, abdominal ultrasound (or CT scan) in case of abnormal hepatic function, and bone scintigraphy required.
• Total absence of previous chemotherapy or radiotherapy, for whatever reason.
• Total absence of surgical procedures for nasopharyngeal carcinoma.
• Total absence of concurrent cancer treatment.
• Total absence of chronic treatment (\>= 3 months) with corticosteroids with a daily dosage \>= 20 mg/day of methylprednisolone or equivalent.
• Age between 18 and 70 years.
• Performance status 0 or 1 according to the WHO criteria.
• Neutrophils \>= 1.5 \* 109/l
• Platelets: \>= 100 \* 109/l
• Hemoglobin: \>= 10 g/dl
• Total bilirubin is normal
• AST (SGOT) and ALT (SGPT) \<= 2.5 \* upper limit of normal (ULN) of each center.
• Alkaline phosphatase \<= 2.5 \* ULN.
• Patient who has given his/her written consent before any specific procedure of the protocol.

You may not qualify if:

• WHO I carcinoma of the nasopharynx, histologically proven by a nasal cavity biopsy.
• Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma.
• Histological diagnosis on a lymph node biopsy.
• Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures.
• Symptomatic peripheral neuropathy with grade \>= 2 according to the NCI-CTC criteria.
• Other serious concurrent medical disease (non-exhaustive list):
• Unstable heart disease despite treatment.
• A history of neurological or psychiatric events such as dementia, convulsions.
• Severe uncontrolled infection.
• Active gastroduodenal ulcer.
• Clinical impairment of auditory function.
• Hypersensitivity to the excipients.
• A patient already enrolled in another therapeutic trial on an investigational compound.
• A person deprived of liberty or in the care of a guardian.

Sponsors & Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou: lead

Study Sites (5)

Hôpital de la Pitié-Salpétrière

Paris, 75013, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

University of Casablanca

Casablanca, Morocco

Location

University of Cluj

Cluj-Napoca, Romania

Location

Hôpital Habib Bourguiba

Sfax, Tunisia

Location

Related Publications (2)

• Tao Y, Auperin A, Graff P, Lapeyre M, Gregoire V, Maingon P, Geoffrois L, Verrelle P, Calais G, Gery B, Martin L, Alfonsi M, Deprez P, Bardet E, Pignon T, Rives M, Sire C, Bourhis J. Very accelerated radiotherapy or concurrent chemoradiotherapy for N3 head and neck squamous cell carcinoma: Pooled analysis of two GORTEC randomized trials. Oral Oncol. 2017 Aug;71:61-66. doi: 10.1016/j.oraloncology.2017.06.002. Epub 2017 Jun 9.

  PMID: 28688693 DERIVED

• Bourhis J, Sire C, Graff P, Gregoire V, Maingon P, Calais G, Gery B, Martin L, Alfonsi M, Desprez P, Pignon T, Bardet E, Rives M, Geoffrois L, Daly-Schveitzer N, Sen S, Tuchais C, Dupuis O, Guerif S, Lapeyre M, Favrel V, Hamoir M, Lusinchi A, Temam S, Pinna A, Tao YG, Blanchard P, Auperin A. Concomitant chemoradiotherapy versus acceleration of radiotherapy with or without concomitant chemotherapy in locally advanced head and neck carcinoma (GORTEC 99-02): an open-label phase 3 randomised trial. Lancet Oncol. 2012 Feb;13(2):145-53. doi: 10.1016/S1470-2045(11)70346-1. Epub 2012 Jan 18.

  PMID: 22261362 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

Induction Chemotherapy

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Remission Induction

Study Officials

• Jamel Daoud, Pr

  Hôpital Habib Bourguiba-3029 Sfax-Tunisie

  PRINCIPAL INVESTIGATOR

• Mounir FRIKHA, Pr

  Hôpital Habib Bourguiba-3029 Sfax-Tunisie

  PRINCIPAL INVESTIGATOR

• Jean BOURHIS, Pr

  Institut Gustave Roussy, 39 rue Camille Desmoulin, Villejuif, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 23, 2009
• Study Start: January 1, 2009
• Primary Completion: April 19, 2017
• Study Completion: April 19, 2017
• Last Updated: January 18, 2019

Record last verified: 2019-01

Locations

MO (1); FR (2); TU (1); RO (1)