Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

NCT01872962 | Unknown Phase 3 DMC

• 1 other identifier: B2013-022-01
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma; Induction chemotherapy; Concurrent chemoradiotherapy; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Failure-free survival

  Failure-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.

  3-year

Secondary Outcomes (4)

• Overall survival

  3-year

• Locoregional failure-free survival

  3-year

• Distant failure-free survival

  3-year

• Number of participants with adverse events

  up to 3 years

Study Arms (2)

Induction chemotherapy+IMRT and concurrent cisplatin

EXPERIMENTAL

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.

Drug: gemcitabine and cisplatin (Induction chemotherapy); Radiation: IMRT and concurrent cisplatin

IMRT and concurrent cisplatin

ACTIVE COMPARATOR

Patients receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.

Radiation: IMRT and concurrent cisplatin

Interventions

gemcitabine and cisplatin (Induction chemotherapy) DRUG

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.

Also known as: gemcitabine and cisplatin (GP)

Induction chemotherapy+IMRT and concurrent cisplatin

IMRT and concurrent cisplatin RADIATION

Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor, concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.

IMRT and concurrent cisplatin; Induction chemotherapy+IMRT and concurrent cisplatin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
• Tumor staged as T3-4N1/N2-3 (according to the 7th AJCC 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.

You may not qualify if:

• WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
• Age \> 65 or \< 18.
• Treatment with palliative intent.
• Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
• Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
• History of previous RT (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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Fudan University: collaborator
• West China Hospital: collaborator
• Tongji Hospital: collaborator
• Peking University: collaborator
• Zhejiang Cancer Hospital: collaborator
• First People's Hospital of Foshan: collaborator
• Cancer Hospital of Guangxi Medical University: collaborator
• Jiangxi Provincial Cancer Hospital: collaborator
• Xijing hospital of The fourth military medical university: collaborator
• Cancer Hospital of Guizhou Province: collaborator
• Affiliated Cancer Hospital of Shantou University Medical College: collaborator
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

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MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Gemcitabine; Cisplatin; Induction Chemotherapy; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Drug Therapy; Therapeutics; Remission Induction; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy

Study Officials

• Jun Ma, M.D.

  Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 7, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2020
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

CN (1)