Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Fudan University
West China Hospital
Huazhong University of Science and Technology
Beijing Cancer Hospital
Zhejiang Cancer Hospital
Central South University
Jiangsu Cancer Institute & Hospital
First People's Hospital of Foshan
The Third Affiliated Hospital of Harbin Medical University
Cancer Hospital of Guangxi Medical University
Jiangxi Cancer Hospital
Guangzhou Medical University
Information provided by (Responsible Party):
Jun Ma, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01245959
First received: November 22, 2010
Last updated: February 12, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to compare induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of induction chemotherapy in NPC patients.


Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: Docetaxel, cisplatin and fluorouracil
Radiation: Concurrent chemoradiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing Induction Chemotherapy Plus Concurrent Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    Overall survival is calculated from randomization to death from any cause.

  • Locoregional failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    The latency (ie, time from randomisation) to the first locoregional failure

  • Distant failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    The latency (ie, time from randomisation) to the first remote failure

  • The initial response rates after treatments [ Time Frame: A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy ] [ Designated as safety issue: No ]
  • Toxic effects [ Time Frame: During and after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 476
Study Start Date: January 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Induction chemotherapy and concurrent chemoradiotherapy
Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Drug: Docetaxel, cisplatin and fluorouracil
Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
Other Name: TPF induction chemotherapy
Radiation: Concurrent chemoradiotherapy
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Other Name: Radical radiotherapy and concurrent cisplatin
Active Comparator: Concurrent chemoradiotherapy
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Radiation: Concurrent chemoradiotherapy
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Other Name: Radical radiotherapy and concurrent cisplatin

Detailed Description:

Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy, and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. Patients in the investigational arm receive docetaxel(60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy. Patients are stratified according to the treatment centers and stage. The primary end point is failure-free survival (FFS). Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response rates after treatments and toxic effects. 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 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
  • Tumor staged as T3-4N1/N2-3 (according to the 7th American Joint Commission on Cancer edition).
  • No evidence of distant metastasis (M0).
  • Satisfactory performance status: Karnofsky scale (KPS) > 70.
  • 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.
  • Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

  • WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  • Age ≥60 years or <18 years.
  • Treatment with palliative intent.
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  • Pregnancy or lactation.
  • History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  • 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.
  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: NCT01245959

Locations
China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Fudan University
West China Hospital
Huazhong University of Science and Technology
Beijing Cancer Hospital
Zhejiang Cancer Hospital
Central South University
Jiangsu Cancer Institute & Hospital
First People's Hospital of Foshan
The Third Affiliated Hospital of Harbin Medical University
Cancer Hospital of Guangxi Medical University
Jiangxi Cancer Hospital
Guangzhou Medical University
Investigators
Study Chair: Jun Ma, M.D. Sun Yat-sen University
  More Information

Publications:
Stephen B. Edge, David R. Byrd, Carolyn C. Compton, April G. Fritz, Frederick L. Greene, and Andy Trotti. AJCC Cancer Staging Manual. 7th ed. New York: Springer, 2009: 41-46.
Qin-Hua Zhang, Wei Luo, Qi-Chao Zhou, Zhan Yu, Jun Ma, Meng-Zhong Liu. TPF induction chemotherapy followed by intensity-modulated radiotherapy and concomitant chemotherapy for locoregionally advanced nasopharyngeal carcinoma. Chinese Journal of Cancer Prevention and Treatment 16(8): 625-628, 2009.

Responsible Party: Jun Ma, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01245959     History of Changes
Other Study ID Numbers: YP2010171
Study First Received: November 22, 2010
Last Updated: February 12, 2014
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
Nasopharyngeal carcinoma
Concurrent chemoradiotherapy
Induction chemotherapy
Clinical trial

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

ClinicalTrials.gov processed this record on October 23, 2014