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

Head and Neck Squamous Cell Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02485548
• Other study ID #: 2014NL-035
• Status: Recruiting
• Phase: Phase 3
• First received: June 26, 2015
• Last updated: June 29, 2015
• Start date: June 2015
• Est. completion date: June 2018

Study information

• Verified date: June 2015
• Source: Jiangsu Cancer Institute & Hospital
• Contact: Xuesong Jiang, M.D.
• Phone: 86138517007
• Email: 13851700790[@]126.com
• Is FDA regulated: No
• Health authority: China: Jiangsu Province Health Department
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Cancer
• Neoplasms, Squamous Cell

Intervention

Drug:
• Raltitrexed
Patients will receive IMRT and concurrent raltitrexed and cisplatin
• 5-fluorouracil
Patients will receive IMRT and concurrent 5-Fu and cisplatin
• Cisplatin
All patients will receive concurrent cisplatin.

Radiation:
• IMRT
All patients will receive IMRT

Locations

Country	Name	City	State
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu

Sponsors (7)

Lead Sponsor	Collaborator
Jiangsu Cancer Institute & Hospital	Changzhou Cancer Hospital, Nanjing BenQ Hospital, Nanjing Cancer Hospital, Northern Jiangsu People’s Hospital, The Second Hospital of Nanjing Medical University, Wuxi Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		36 months	Yes
Secondary	Overall Survival (OS)		36 months	Yes
Secondary	Locoregional and distant control rate		36 months	Yes
Secondary	Percentage of participants experiencing grade 3-5 adverse events(AEs)		36 months	Yes