Cisplatin Plus Raltitrexed or 5-fluorouracil Concurrent With Radiotherapy for Head and Neck Squamous Cell Cancer

June 29, 2015 updated by: Dr. Xia He, Jiangsu Cancer Institute & Hospital

A Multicenter Phase Ⅲ Trial of Cisplatin Plus Raltitrexed or 5-fluorouracil in Concurrence With Intensity-modulated Radiotherapy (IMRT) for the Treatment of Locoregionally Advanced Head and Neck Squamous Cell Cancer

This study is a multicenter phase Ⅲ trial. The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.

Study Overview

Detailed Description

The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:
        • Sub-Investigator:
          • Xuesong Jiang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically confirmed untreated head and neck squamous cell cancer patients
  • 18-70 years
  • Clinical stage: T3-4N0-3M0 or T1-4N1-3M0
  • Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
  • Renal function: Cr ≤ 1.25×UNL
  • Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
  • ECOG ≤ 1
  • Woman and man of childbearing age must adopt contraception
  • With written consent

Exclusion Criteria:

  • Malignant history
  • Pregnant or lactating women
  • With other severe diseases (blood, liver ,kidney or heart diseases)
  • Subjects not suitable for chemo-radiotherapy
  • Without written consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Raltitrexed plus cisplatin
Raltitrexed plus cisplatin and IMRT
Patients will receive IMRT and concurrent raltitrexed and cisplatin
All patients will receive concurrent cisplatin.
All patients will receive IMRT
Active Comparator: 5-fluorouracil plus cisplatin
5-fluorouracil plus cisplatin and IMRT
All patients will receive concurrent cisplatin.
All patients will receive IMRT
Patients will receive IMRT and concurrent 5-Fu and cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: 36 months
36 months
Locoregional and distant control rate
Time Frame: 36 months
36 months
Percentage of participants experiencing grade 3-5 adverse events(AEs)
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Estimate)

June 30, 2015

Last Update Submitted That Met QC Criteria

June 29, 2015

Last Verified

June 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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