The Value of Single-cycle TPF Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-12-31

Brief Summary

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Two Phase Ⅲ trials (TAX323 and TAX324) showed induction chemotherapy adding docetaxel to cisplatin plus fluorouracil (TPF) could significant improve survival in head and neck cancer, and a Phase Ⅱ trial from Hong Kong by Hui and colleges with this strategy has also been reported in nasopharyngeal carcinoma (NPC). However, whether three cycles induction could delay the whole time of treatment and reduce the survival benefit are still unknown. A retrospective study of one cycle TPF induction chemotherapy by the investigators group (not yet published) could improve survival in NPC. It encourage us to conduct this clinical trial.

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Detailed Description

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Patients presented with non-keratinizing NPC and stage Ⅲ-Ⅳb T3-4N1M0/TxN2M0 are randomly assigned to receive one cycle induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy (investigational arm) or three cycles induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy (investigational arm)(control arm). Patients in both arms receive radical Intensity modulated radiation therapy (Trilogy, Varian), and cisplatin (30mg/m2) every weeks for six cycles during radiotherapy. Radiation is delivered to GTV at 70 Gy in 30 fractions, CTV1 at at 60 Gy in 30 fractions and CTV2 at 54 Gy in 30 fractions. Patients in the investigational arm receive docetaxel (60mg/m2 on day 1), cisplatin (20mg/m2 on day 1-4) and fluorouracil (800mg/m2/d,continuous infusion, day 1-4) every three weeks for one cycle or three cycles before the radiotherapy. The primary end point is response rates after radiotherapy, failure-free survival (FFS) and toxic effects and treatment compliance. Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS). All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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one cycle induction chemotherapy

Drug: docetaxel, cisplatin and fluorouracil

Patients receive docetaxel (60mg/m2 on day 1), cisplatin (20mg/m2 on day 1-4) and fluorouracil (800mg/m2/d, continuous infusion, d1-4) every three weeks for single one cycle before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2) every week for six cycles during radiotherapy.

Other Names:

docetaxel, cisplatin and fluorouracil

One cycle TPF induction chemotherapy for NPC

Intervention Type DRUG

One cycle TPF induction chemotherapy for NPC

Patients receive docetaxel (60mg/m2 on day 1), cisplatin (20mg/m2 on day 1-4) and fluorouracil (800mg/m2/d, continuous infusion, d1-4) every three weeks for single one cycle before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2) every week for six cycles during radiotherapy.

A total dose of 70Gy in 30 fraction to PTV-P, 60Gy in 30 fraction to PTV-1 and 54Gy in 30 fraction to PTV-2.

three cycles induction chemotherapy

Drug: docetaxel, cisplatin and fluorouracil

Patients receive docetaxel (60mg/m2 on day 1), cisplatin (20mg/m2 on day 1-4) and fluorouracil (800mg/m2/d, continuous infusion, d1-4) every three weeks for three cycles before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2) every week for six cycles during radiotherapy.

Other Names:

docetaxel, cisplatin and fluorouracil

Three cycles TPF induction chemotherapy for NPC

Intervention Type DRUG

Three cycles TPF induction chemotherapy for NPC

Patients receive docetaxel (60mg/m2 on day 1), cisplatin (20mg/m2 on day 1-4) and fluorouracil (800mg/m2/d, continuous infusion, d1-4) every three weeks for three cycles before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2) every week for six cycles during radiotherapy.

A total dose of 70Gy in 30 fraction to PTV-P, 60Gy in 30 fraction to PTV-1 and 54Gy in 30 fraction to PTV-2.

Interventions

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One cycle TPF induction chemotherapy for NPC

One cycle TPF induction chemotherapy for NPC

Patients receive docetaxel (60mg/m2 on day 1), cisplatin (20mg/m2 on day 1-4) and fluorouracil (800mg/m2/d, continuous infusion, d1-4) every three weeks for single one cycle before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2) every week for six cycles during radiotherapy.

A total dose of 70Gy in 30 fraction to PTV-P, 60Gy in 30 fraction to PTV-1 and 54Gy in 30 fraction to PTV-2.

Intervention Type DRUG

Three cycles TPF induction chemotherapy for NPC

Three cycles TPF induction chemotherapy for NPC

Patients receive docetaxel (60mg/m2 on day 1), cisplatin (20mg/m2 on day 1-4) and fluorouracil (800mg/m2/d, continuous infusion, d1-4) every three weeks for three cycles before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2) every week for six cycles during radiotherapy.

A total dose of 70Gy in 30 fraction to PTV-P, 60Gy in 30 fraction to PTV-1 and 54Gy in 30 fraction to PTV-2.

Intervention Type DRUG

Other Intervention Names

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One cycle induction chemotherapy Docetaxel, cisplatin and 5-Fu Three cycles induction chemotherapy Decotaxel, Cisplatin and 5-Fu

Eligibility Criteria

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Inclusion Criteria

* Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).
* Satisfactory performance status: Karnofsky scale (KPS) \> 70.
* Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0
* Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
* Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
* Adequate renal function: creatinine clearance ≥60 ml/min.

Exclusion Criteria

* Age \>60 years or \<18 years.
* Pregnancy or lactation.
* Treatment with palliative intent.
* Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
* Any severe intercurrent disease including unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control and emotional disturbance.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No