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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by First People's Hospital of Foshan
Sponsor:
Information provided by (Responsible Party):
Tao Xu, First People's Hospital of Foshan
ClinicalTrials.gov Identifier:
NCT02096380
First received: November 13, 2011
Last updated: March 22, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: One cycle TPF induction chemotherapy for NPC
Drug: Three cycles TPF induction chemotherapy for NPC
Phase 2
Phase 3

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Randomized Trial of Comparing One Cycle With Three Cycles Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Locoregionally Advanced Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by First People's Hospital of Foshan:

Primary Outcome Measures:
  • Failure-free survival [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
    Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.


Secondary Outcome Measures:
  • Locoregional failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
    the data of randomization to the first local failure,

  • Overall survival [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
    Overall survival is calculated from randomization to death from any cause.

  • Distant failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
    the data of randomization to the first remote failure


Estimated Enrollment: 120
Study Start Date: May 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Drug: 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.

Other Names:
  • One cycle
  • induction chemotherapy
  • Docetaxel,
  • cisplatin
  • and 5-Fu
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

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.

Other Names:
  • Three cycles
  • induction chemotherapy
  • Decotaxel,
  • Cisplatin
  • and 5-Fu

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients diagnosed with locoregionally advanced nasopharyngeal carcinoma and agree to receive anti-cancer treatment in our hospital

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02096380

Contacts
Contact: Hong W WEI, M.D. +86-757-83162835 wwhong@fsyyy.com

Sponsors and Collaborators
First People's Hospital of Foshan
Investigators
Study Director: Hong W Wei, M.D. First People's Hospital of Foshan
  More Information

Publications:

Responsible Party: Tao Xu, Principal investigator, Department of radiation oncology for head and neck cancer, First People's Hospital of Foshan, First People's Hospital of Foshan
ClinicalTrials.gov Identifier: NCT02096380     History of Changes
Other Study ID Numbers: FSHNG-1110
Study First Received: November 13, 2011
Last Updated: March 22, 2014
Health Authority: China: Ethics Committee

Keywords provided by First People's Hospital of Foshan:
Nasopharyngeal Carcinoma
cycle
induction chemotherapy
docetaxel

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 28, 2014