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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02485548
Recruitment Status : Unknown
Verified June 2015 by Dr. Xia He, Jiangsu Cancer Institute & Hospital.
Recruitment status was:  Recruiting
First Posted : June 30, 2015
Last Update Posted : June 30, 2015
Sponsor:
Collaborators:
Affiliated Hospital of Jiangnan University
Changzhou Cancer Hospital of Soochow University
The First Affiliated Hospital with Nanjing Medical University
Northern Jiangsu Province People's Hospital
The Second Hospital of Nanjing Medical University
Nanjing BenQ Hospital
Information provided by (Responsible Party):
Dr. Xia He, Jiangsu Cancer Institute & Hospital

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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Cancer Drug: Raltitrexed Drug: 5-fluorouracil Drug: Cisplatin Radiation: IMRT Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Raltitrexed plus cisplatin
Raltitrexed plus cisplatin and IMRT
Drug: Raltitrexed
Patients will receive IMRT and concurrent raltitrexed and cisplatin

Drug: Cisplatin
All patients will receive concurrent cisplatin.

Radiation: IMRT
All patients will receive IMRT

Active Comparator: 5-fluorouracil plus cisplatin
5-fluorouracil plus cisplatin and IMRT
Drug: 5-fluorouracil
Patients will receive IMRT and concurrent 5-Fu and cisplatin

Drug: Cisplatin
All patients will receive concurrent cisplatin.

Radiation: IMRT
All patients will receive IMRT




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 36 months ]
  2. Locoregional and distant control rate [ Time Frame: 36 months ]
  3. Percentage of participants experiencing grade 3-5 adverse events(AEs) [ Time Frame: 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485548


Contacts
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Contact: Xuesong Jiang, M.D. 86138517007 13851700790@126.com

Locations
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China, Jiangsu
Jiangsu Cancer Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Xuesong Jiang, M.D.       13851700790@126.com   
Sub-Investigator: Xuesong Jiang, M.D.         
Sponsors and Collaborators
Jiangsu Cancer Institute & Hospital
Affiliated Hospital of Jiangnan University
Changzhou Cancer Hospital of Soochow University
The First Affiliated Hospital with Nanjing Medical University
Northern Jiangsu Province People's Hospital
The Second Hospital of Nanjing Medical University
Nanjing BenQ Hospital
Investigators
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Principal Investigator: Xia He, M.D. Jiangsu Cancer Institute & Hospital

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Responsible Party: Dr. Xia He, Director of Radiation Oncology, Jiangsu Cancer Institute & Hospital
ClinicalTrials.gov Identifier: NCT02485548    
Other Study ID Numbers: 2014NL-035
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma
Cisplatin
Fluorouracil
Raltitrexed
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Enzyme Inhibitors