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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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02485548
Enrollment
120
Registered
2015-06-30
Start date
2015-06-30
Completion date
2018-06-30
Last updated
2015-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Squamous Cell Cancer

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.

Interventions

DRUGRaltitrexed

Patients will receive IMRT and concurrent raltitrexed and cisplatin

DRUG5-fluorouracil

Patients will receive IMRT and concurrent 5-Fu and cisplatin

DRUGCisplatin

All patients will receive concurrent cisplatin.

RADIATIONIMRT

All patients will receive IMRT

Sponsors

Affiliated Hospital of Jiangnan University
CollaboratorOTHER
Changzhou Cancer Hospital of Soochow University
CollaboratorOTHER
The First Affiliated Hospital with Nanjing Medical University
CollaboratorOTHER
Northern Jiangsu People's Hospital
CollaboratorOTHER
The Second Hospital of Nanjing Medical University
CollaboratorOTHER
Nanjing BenQ Hospital
CollaboratorUNKNOWN
Jiangsu Cancer Institute & Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS)36 months

Secondary

MeasureTime frame
Overall Survival (OS)36 months
Locoregional and distant control rate36 months
Percentage of participants experiencing grade 3-5 adverse events(AEs)36 months

Countries

China

Contacts

Primary ContactXuesong Jiang, M.D.
13851700790@126.com86138517007

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026