Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers

Nasopharyngeal Cancers Clinical Trial

— NPC2006  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00828386
• Other study ID #: GORTEC NPC2006
• Status: Terminated
• Phase: Phase 3
• Start date: January 2009
• Est. completion date: April 19, 2017

Study information

• Verified date: January 2019
• Source: Groupe Oncologie Radiotherapie Tete et Cou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: April 19, 2017
• Est. primary completion date: April 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasopharyngeal Cancers
• Nasopharyngeal Neoplasms

Intervention

Procedure:
• Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy
Induction chemotherapy (Docetaxel, Cisplatin and 5-Fluorouracil) + concurrent radiochemotherapy

Locations

Country	Name	City	State
France	Hôpital de la Pitié-Salpétrière	Paris
France	Institut Gustave Roussy	Villejuif
Morocco	University of Casablanca	Casablanca
Romania	University of Cluj	Cluj
Tunisia	Hôpital Habib Bourguiba	Sfax

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Oncologie Radiotherapie Tete et Cou

Countries where clinical trial is conducted

France,  Morocco,  Romania,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free-survival		3 years
Secondary	Survival		3 years
Secondary	late and acute toxicity according to NCI-CTC and EORTC/RTOG criteria		early and late
Secondary	Cumulative incidence of loco-regional progression		3 years
Secondary	Cumulative rate of metastasis		3 years
Secondary	Global response to chemo-radiotherapy		3 years
Secondary	Global response to induction chemotherapy		after the induction chemotherapy of the last patient included