Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers (GORTEC-NPC2006)

This study has been terminated.
(Low accrual)
Sponsor:
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT00828386
First received: January 22, 2009
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Nasopharyngeal Cancers
Procedure: Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Groupe Oncologie Radiotherapie Tete et Cou:

Primary Outcome Measures:
  • Event free-survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: early and late ] [ Designated as safety issue: Yes ]
  • Cumulative incidence of loco-regional progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Cumulative rate of metastasis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Global response to chemo-radiotherapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Global response to induction chemotherapy [ Time Frame: after the induction chemotherapy of the last patient included ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: January 2009
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Induction chemotherapy + concurrent chemoradiotherapy

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
Induction chemotherapy (Docetaxel, Cisplatin and 5-Fluorouracil) + concurrent radiochemotherapy
Active Comparator: Concurrent radiochemotherapy alone
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
Induction chemotherapy (Docetaxel, Cisplatin and 5-Fluorouracil) + concurrent radiochemotherapy

Detailed Description:

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

The treatments are :

Arm A:

induction chemotherapy: 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 )+ 5-FU (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 chemoradiotherapy with Cisplatin (40 mg/m2 starting on D1 of the radiation therapy) during 7 weeks

Arm B: Chemoradiotherapy with Cisplatin alone (40 mg/m2 starting on D1 of the radiation therapy) during 7 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. 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.
  3. Total absence of previous chemotherapy or radiotherapy, for whatever reason.
  4. Total absence of surgical procedures for nasopharyngeal carcinoma.
  5. Total absence of concurrent cancer treatment.
  6. Total absence of chronic treatment (>= 3 months) with corticosteroids with a daily dosage >= 20 mg/day of methylprednisolone or equivalent.
  7. Age between 18 and 70 years.
  8. Performance status 0 or 1 according to the WHO criteria.
  9. Hematological function parameters performed within 10 days before inclusion:

    • Neutrophils >= 1.5 * 109/l
    • Platelets: >= 100 * 109/l
    • Hemoglobin: >= 10 g/dl
  10. Hepatic function parameters performed within 10 days before inclusion:

    • Total bilirubin is normal
    • AST (SGOT) and ALT (SGPT) <= 2.5 * upper limit of normal (ULN) of each center.
    • Alkaline phosphatase <= 2.5 * ULN.
  11. Renal function parameters performed within 10 days before inclusion: Creatinine clearance must be <= 55 ml/min.
  12. Patient who has given his/her written consent before any specific procedure of the protocol.
  13. Patient having a Social Security (social policy-holders)

Exclusion Criteria:

  1. WHO I carcinoma of the nasopharynx, histologically proven by a nasal cavity biopsy.
  2. Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma.
  3. Histological diagnosis on a lymph node biopsy.
  4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures.
  5. Symptomatic peripheral neuropathy with grade >= 2 according to the NCI-CTC criteria.
  6. Other serious concurrent medical disease (non-exhaustive list):

    • Unstable heart disease despite treatment.
    • Myocardial infarction within 6 months before inclusion in the trial.
    • A history of neurological or psychiatric events such as dementia, convulsions.
    • Severe uncontrolled infection.
    • Active gastroduodenal ulcer.
    • Obstructive Pulmonary Disease requiring hospitalization within the year prior to inclusion.
  7. Clinical impairment of auditory function.
  8. The presence, at time of screening, of psychological, familial, social or geographical factors that may have an effect on the compliance of the patient with the study protocol and monitoring comprises an exclusion criterion. These factors must be discussed with the patient before his or her inclusion in the trial.
  9. Hypersensitivity to the excipients.
  10. A patient already enrolled in another therapeutic trial on an investigational compound.
  11. A person deprived of liberty or in the care of a guardian.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828386

Locations
France
Hôpital de la Pitié-Salpétrière
Paris, France, 75013
Institut Gustave Roussy
Villejuif, France, 94805
Morocco
University of Casablanca
Casablanca, Morocco
Romania
University of Cluj
Cluj, Romania
Tunisia
Hôpital Habib Bourguiba
Sfax, Tunisia
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
Investigators
Principal Investigator: 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
  More Information

No publications provided by Groupe Oncologie Radiotherapie Tete et Cou

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT00828386     History of Changes
Other Study ID Numbers: GORTEC-NPC2006
Study First Received: January 22, 2009
Last Updated: January 2, 2014
Health Authority: France: Ministry of Health

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
Nasopharyngeal cancers
induction chemotherapy
radiochemotherapy

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 19, 2014