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

Primary Purpose

Head and Neck Squamous Cell Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Raltitrexed
5-fluorouracil
Cisplatin
IMRT
Sponsored by
Jiangsu Cancer Institute & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jiangsu Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Raltitrexed plus cisplatin

5-fluorouracil plus cisplatin

Arm Description

Raltitrexed plus cisplatin and IMRT

5-fluorouracil plus cisplatin and IMRT

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

Secondary Outcome Measures

Overall Survival (OS)
Locoregional and distant control rate
Percentage of participants experiencing grade 3-5 adverse events(AEs)

Full Information

First Posted
June 26, 2015
Last Updated
June 29, 2015
Sponsor
Jiangsu Cancer Institute & Hospital
Collaborators
Affiliated Hospital of Jiangnan University, Changzhou Cancer Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, Northern Jiangsu Province People's Hospital, The Second Hospital of Nanjing Medical University, Nanjing BenQ Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02485548
Brief Title
Cisplatin Plus Raltitrexed or 5-fluorouracil Concurrent With Radiotherapy for Head and Neck Squamous Cell Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangsu Cancer Institute & Hospital
Collaborators
Affiliated Hospital of Jiangnan University, Changzhou Cancer Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, Northern Jiangsu Province People's Hospital, The Second Hospital of Nanjing Medical University, Nanjing BenQ Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Raltitrexed plus cisplatin
Arm Type
Experimental
Arm Description
Raltitrexed plus cisplatin and IMRT
Arm Title
5-fluorouracil plus cisplatin
Arm Type
Active Comparator
Arm Description
5-fluorouracil plus cisplatin and IMRT
Intervention Type
Drug
Intervention Name(s)
Raltitrexed
Intervention Description
Patients will receive IMRT and concurrent raltitrexed and cisplatin
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Intervention Description
Patients will receive IMRT and concurrent 5-Fu and cisplatin
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
All patients will receive concurrent cisplatin.
Intervention Type
Radiation
Intervention Name(s)
IMRT
Intervention Description
All patients will receive IMRT
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
36 months
Title
Locoregional and distant control rate
Time Frame
36 months
Title
Percentage of participants experiencing grade 3-5 adverse events(AEs)
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuesong Jiang, M.D.
Phone
86138517007
Email
13851700790@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xia He, M.D.
Organizational Affiliation
Jiangsu Cancer Institute & Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuesong Jiang, M.D.
Email
13851700790@126.com
First Name & Middle Initial & Last Name & Degree
Xuesong Jiang, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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