Induction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma

Brief Title

Induction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma

Official Title

Phase II Study Comparing Gemcitabine Plus Cisplatin to Docetaxel, Cisplatin, and Fluorouracil Induction Chemotherapy Followed by Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

Brief Summary

      The present study is a randomized, control, phase II study of locally advanced nasopharyngeal
      carcinoma (NPC) treated with Gemcitabine plus cisplatin regimen (GP) or Docetaxel，cisplatin
      regimen plus 5-Fluorouracil (TPF) induction chemotherapy followed by concurrent
      chemoradiotherapy.

Detailed Description

      Nasopharyngeal carcinoma (NPC) prevalence is reported to be highest in southern China, where
      an average of 80 cases per 100,000 population are reported each year. Nasopharyngeal
      carcinoma is both radiosensitive and chemosensitive. The National Comprehensive Cancer
      Network (NCCN) guidelines (version 1, 2013), have recommended use of concurrent
      chemoradiotherapy (CCRT) with or without adjuvant chemotherapy (AC) and induction
      chemotherapy (IC) followed by CCRT plus AC as standard treatment for NPC. However, it was
      unclear whether patients with NPC could benefit from IC. Recently, many new drugs including
      docetaxel and gemcitabine have been incorporated in the induction chemotherapy phase of NPC.
      The investigators designed the present study with induction chemotherapy follow by CCRT for
      locoregionally advanced NPC, comparing induction chemotherapy regime of gemcitabine plus
      cisplatin (GP) and docetaxel, cisplatin, and fluorouracil (TPF).

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Failure-free survival (FFS)

Secondary Outcome

 Overall survival (OS)

Condition

Nasopharyngeal Carcinoma

Intervention

A combination of Gemcitabine and cisplatin

Study Arms / Comparison Groups

 A combination of Gemcitabine and cisplatin

Description:  The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT.

Publications

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

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

May 2014

Completion Date

December 2020

Primary Completion Date

December 2016

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with newly histologically confirmed non-keratinizing (according to WHO
             histologically type).

          2. 18 years to 70 years;

          3. Tumor staged as T3-4N1/N2-3M0 (according to the 7th AJCC edition),

          4. Performance status: Karnofsky scale (KPS) > 70 (Appendix I ).

          5. Adequate marrow: leucocyte count > 4×109/L, neutrophil count > 2×109/L, hemoglobin >
             90g/L and platelet count > 100×109/L.

          6. 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.

          7. Adequate renal function: creatinine clearance > 60 ml/min.

          8. Patients must be informed of the investigational nature of this study and give written
             informed consent.

        Exclusion Criteria:

          1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.

          2. Age > 70 or < 18.

          3. Treatment with palliative intent.

          4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in
             situ cervical cancer.

          5. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and
             emphasize effective contraception during the treatment period).

          6. History of previous RT (except for non-melanomatous skin cancers outside intended RT
             treatment volume).

          7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.

          8. Any severe intercurrent disease, which may bring unacceptable risk or affect the
             compliance of the trial, for example, unstable cardiac disease requiring treatment,
             renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >
             1.5×ULN), and emotional disturbance.

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Xiaodong Zhu, Doctor, 867715331466, [email protected]

Administrative Informations

NCT ID

NCT02016417

Organization ID

CHGX20131212

Responsible Party

Sponsor

Study Sponsor

Cancer Hospital of Guangxi Medical University

Study Sponsor

Xiaodong Zhu, Doctor, Study Chair, Cancer Institute of Guangxi Zhuang Autonomous Region

Verification Date

December 2013