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

Sponsor
Jiangsu Cancer Institute & Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02485548
Collaborator
Affiliated Hospital of Jiangnan University (Other), Changzhou Cancer Hospital of Soochow University (Other), The First Affiliated Hospital with Nanjing Medical University (Other), Northern Jiangsu Province People's Hospital (Other), The Second Hospital of Nanjing Medical University (Other), Nanjing BenQ Hospital (Other)
120
Enrollment
1
Location
2
Arms
36
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2018
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Raltitrexed plus cisplatin

Raltitrexed plus cisplatin and IMRT

Drug: Raltitrexed
Patients will receive IMRT and concurrent raltitrexed and cisplatin

Drug: Cisplatin
All patients will receive concurrent cisplatin.

Radiation: IMRT
All patients will receive IMRT
Active Comparator: 5-fluorouracil plus cisplatin

5-fluorouracil plus cisplatin and IMRT

Drug: 5-fluorouracil
Patients will receive IMRT and concurrent 5-Fu and cisplatin

Drug: Cisplatin
All patients will receive concurrent cisplatin.

Radiation: IMRT
All patients will receive IMRT

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival (PFS) [36 months]

Secondary Outcome Measures

  1. Overall Survival (OS) [36 months]

  2. Locoregional and distant control rate [36 months]

  3. Percentage of participants experiencing grade 3-5 adverse events(AEs) [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jiangsu Cancer Hospital Nanjing Jiangsu China 210009

Sponsors and Collaborators

  • Jiangsu Cancer Institute & Hospital
  • 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

Investigators

  • Principal Investigator: Xia He, M.D., Jiangsu Cancer Institute & Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Xia He, Director of Radiation Oncology, Jiangsu Cancer Institute & Hospital
ClinicalTrials.gov Identifier:
NCT02485548
Other Study ID Numbers:
  • 2014NL-035
First Posted:
Jun 30, 2015
Last Update Posted:
Jun 30, 2015
Last Verified:
Jun 1, 2015
Additional relevant MeSH terms:
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Fluorouracil
Raltitrexed

Study Results

No Results Posted as of Jun 30, 2015