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

Jiangsu Cancer Hospital

Status and phase: Unknown; Phase 3

Conditions: Head and Neck Squamous Cell Cancer

Treatments: Radiation: IMRT; Drug: Raltitrexed; Drug: Cisplatin; Drug: 5-fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT02485548

2014NL-035

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Raltitrexed plus cisplatin

Experimental group

Description:

Raltitrexed plus cisplatin and IMRT

Treatment:

Drug: Cisplatin

Radiation: IMRT

Drug: Raltitrexed

5-fluorouracil plus cisplatin

Active Comparator group

Description:

5-fluorouracil plus cisplatin and IMRT

Treatment:

Drug: Cisplatin

Drug: 5-fluorouracil

Radiation: IMRT