Trial | NCT02485548  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
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.
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 Started
Jun 30
2015
Primary Completion
Jun 30
2018
Anticipated
Study Completion
Jun 30
2018
Anticipated
Last Update
Jun 30
2015
Estimate

Drug Cisplatin

All patients will receive concurrent cisplatin.

Radiation IMRT

All patients will receive IMRT

Drug Raltitrexed

Patients will receive IMRT and concurrent raltitrexed and cisplatin

Drug 5-fluorouracil

Patients will receive IMRT and concurrent 5-Fu and cisplatin

Raltitrexed plus cisplatin Experimental

Raltitrexed plus cisplatin and IMRT

5-fluorouracil plus cisplatin Active Comparator

5-fluorouracil plus cisplatin and IMRT

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
No Results Posted