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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)


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Nasopharyngeal Cancers

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Trial Information

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)


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


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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Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event free-survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Jamel Daoud, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Habib Bourguiba-3029 Sfax-Tunisie

Authority:

France: Ministry of Health

Study ID:

GORTEC-NPC2006

NCT ID:

NCT00828386

Start Date:

January 2009

Completion Date:

September 2016

Related Keywords:

  • Nasopharyngeal Cancers
  • Nasopharyngeal cancers
  • induction chemotherapy
  • radiochemotherapy
  • Nasopharyngeal Neoplasms

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