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

NCT ID: NCT02485548

Last Updated: 2015-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Head and Neck Squamous Cell Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Raltitrexed plus cisplatin

Raltitrexed plus cisplatin and IMRT

Group Type EXPERIMENTAL

Raltitrexed

Intervention Type DRUG

Patients will receive IMRT and concurrent raltitrexed and cisplatin

Cisplatin

Intervention Type DRUG

All patients will receive concurrent cisplatin.

IMRT

Intervention Type RADIATION

All patients will receive IMRT

5-fluorouracil plus cisplatin

5-fluorouracil plus cisplatin and IMRT

Group Type ACTIVE_COMPARATOR

5-fluorouracil

Intervention Type DRUG

Patients will receive IMRT and concurrent 5-Fu and cisplatin

Cisplatin

Intervention Type DRUG

All patients will receive concurrent cisplatin.

IMRT

Intervention Type RADIATION

All patients will receive IMRT

Interventions

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Raltitrexed

Patients will receive IMRT and concurrent raltitrexed and cisplatin

Intervention Type DRUG

5-fluorouracil

Patients will receive IMRT and concurrent 5-Fu and cisplatin

Intervention Type DRUG

Cisplatin

All patients will receive concurrent cisplatin.

Intervention Type DRUG

IMRT

All patients will receive IMRT

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Jiangnan University

OTHER

Sponsor Role collaborator

Changzhou Cancer Hospital of Soochow University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Northern Jiangsu People's Hospital

OTHER

Sponsor Role collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role collaborator

Nanjing BenQ Hospital

UNKNOWN

Sponsor Role collaborator

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Xia He

Director of Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xia He, M.D.

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Cancer Institute & Hospital

Locations

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Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xuesong Jiang, M.D.

Role: CONTACT

Phone: 86138517007

Email: [email protected]

Facility Contacts

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Xuesong Jiang, M.D.

Role: primary

Other Identifiers

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2014NL-035

Identifier Type: -

Identifier Source: org_study_id