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

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ClinicalTrials.gov Identifier: NCT02016417
Recruitment Status : Unknown
Verified December 2013 by Cancer Hospital of Guangxi Medical University.
Recruitment status was:  Not yet recruiting
First Posted : December 20, 2013
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Cancer Hospital of Guangxi Medical University

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: A combination of Gemcitabine and cisplatin Drug: A combination of Docetaxel, cisplatin and 5-Fluorouracil Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Comparing Gemcitabine Plus Cisplatin to Docetaxel, Cisplatin, and Fluorouracil Induction Chemotherapy Followed by Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
Study Start Date : May 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: A combination of Gemcitabine and cisplatin
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.
Drug: A combination of Gemcitabine and cisplatin
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.
Other Name: GP

Active Comparator: A combination of Docetaxel, cisplatin and 5-Fluorouracil
The TPF regimen consists of docetaxel at a dose of 60 mg/m2/day on day 1, cisplatin 60 mg/m2 by i.v. infusion for 4 h on day 1-3, plus 5-Fluorouracil 600 mg/m2 CIV over 120 hours. 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.
Drug: A combination of Docetaxel, cisplatin and 5-Fluorouracil
The TPF regimen consists of docetaxel at a dose of 60 mg/m2/day on day 1, cisplatin 60 mg/m2 by i.v. infusion for 4 h on day 1-3, plus 5-Fluorouracil 600 mg/m2 CIV over 120 hours. 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.
Other Name: TPF




Primary Outcome Measures :
  1. Failure-free survival (FFS) [ Time Frame: One year ]
    From the date of registration to the date of either locally, regionally or distant failure or last follow-up


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: One year ]
    Survival from the date of registration to the date of death or last follow-up

  2. Loco-regional failure-free survival (LFFS) [ Time Frame: One year ]
    Survival from the date of registration to the date of either locally, regional recurrence or last follow-up

  3. Distant metastasis failure-free survival (DMFS) [ Time Frame: One year ]
    Survival from the date of registration to the date of either distant metastasis or last follow-up

  4. Acute induction chemotherapy toxicity [ Time Frame: Two months ]
    The side effects will be evaluated according to NCI-CTC AE V 3.0.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016417


Contacts
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Contact: xiaodong Zhu, Doctor 867715331466 zhuxiaodong83@163.com
Contact: Song Qu, Doctor 867715331466 daisyqs2002@163.com

Sponsors and Collaborators
Cancer Hospital of Guangxi Medical University
Investigators
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Study Chair: Xiaodong Zhu, Doctor Cancer Institute of Guangxi Zhuang Autonomous Region
Additional Information:
Publications:

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Responsible Party: Cancer Hospital of Guangxi Medical University
ClinicalTrials.gov Identifier: NCT02016417    
Other Study ID Numbers: CHGX20131212
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: December 2013
Keywords provided by Cancer Hospital of Guangxi Medical University:
Nasopharyngeal carcinoma
Induction chemotherapy
Concurrent chemoradiotherapy
Gemcitabine
Docetaxel
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gemcitabine
Cisplatin
Docetaxel
Fluorouracil
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents