Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers

Brief Title

Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers

Official Title

A Randomized, Multicenter, Phase III Trial Comparing Induction CT With Docetaxel, Cisplatin and 5-FU (TPF) Followed by Concurrent CT-RT to Concurrent CT Alone, in Nasopharyngeal Cancers Staged as T2b, T3, T4 and/or With Lymph Node Involvement (>N1)

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.
    

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
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Event free-survival

Secondary Outcome

 Survival

Condition

Nasopharyngeal Cancers

Intervention

Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy

Study Arms / Comparison Groups

 Induction chemotherapy + concurrent chemoradiotherapy

Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

83

Start Date

January 2009

Completion Date

April 19, 2017

Primary Completion Date

April 19, 2017

Eligibility 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.

             -
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Jamel Daoud, Pr, , 

Location Countries

France

Location Countries

France

NCT ID

NCT00828386

Organization ID

GORTEC NPC2006

Responsible Party

Sponsor

Study Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Study Sponsor

Jamel Daoud, Pr, Principal Investigator, Hôpital Habib Bourguiba-3029 Sfax-Tunisie

Verification Date

January 2019