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Weekly Cisplatin or Nedaplatin Concurrent With Intensity-modulated Radiation Therapy in Nasopharyngeal Carcinoma (NPC-RCT-WCRT)

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: NCT02301208
Recruitment Status : Unknown
Verified December 2014 by He Xia, Jiangsu Cancer Institute & Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 25, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
He Xia, Jiangsu Cancer Institute & Hospital

Brief Summary:
This is a randomized Phase III study to evaluate efficancy of weekly cisplatin or nedaplatin concurrent with Intensity-modulated radiation therapy in Nasopharyngeal Carcinoma (NPC).

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Nedaplatin Drug: Cisplatin Phase 3

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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 Randomized Phase III Study of Concurrent Weekly Nedaplatin or Cisplatin With IMRT in NPC Patients
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Active Comparator: Low dose cisplatin arm
concurrent chemotherapy: cisplatin 20mg/m2,weekly,for 6 cycles during radiotherapy
Drug: Cisplatin
Cisplatin combine with IMRT
Other Names:
  • PDD
  • DDP
  • CDDP

Active Comparator: High dose cisplatin arm
concurrent chemotherapy: cisplatin 30mg/m2,weekly,for 6 cycles during radiotherapy
Drug: Cisplatin
Cisplatin combine with IMRT
Other Names:
  • PDD
  • DDP
  • CDDP

Experimental: Low dose nedaplatin arm
concurrent chemotherapy: nedaplatin 20mg/m2,weekly,for 6 cycles during radiotherapy
Drug: Nedaplatin
Nedaplatin combine with IMRT
Other Name: NDP

Experimental: High dose nedaplatin arm
concurrent chemotherapy: nedaplatin 30mg/m2,weekly,for 6 cycles during radiotherapy
Drug: Nedaplatin
Nedaplatin combine with IMRT
Other Name: NDP




Primary Outcome Measures :
  1. Response rate [ Time Frame: 2 years ]
  2. Progress-free survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Tumor response [ Time Frame: radiotherapy in 2 week、4 week、7 week ]
  2. Overall survival [ Time Frame: 2 years ]


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 NPC patients
  • T1-2N1-3M0 or T3-4NxM0
  • 18-70 years old
  • with MRI examinations
  • ECOG ≤ 2
  • With written consent

Exclusion Criteria:

  • With a second cancer
  • Pregnancy
  • With other severe diseases (blood,liver ,kidney or heart diseases)
  • Could not be staged properly
  • 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): NCT02301208


Contacts
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Contact: Li Yin, M.D. Ph.D. +8613913909043 yinli7878@sina.com
Contact: Pengwei Yan, M.M. +8613815888775 179032794@qq.com

Sponsors and Collaborators
He Xia

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Responsible Party: He Xia, Jiangsu Cancer Hospital, Jiangsu Cancer Institute & Hospital
ClinicalTrials.gov Identifier: NCT02301208     History of Changes
Other Study ID Numbers: JiangsuCIH
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Nedaplatin
Antineoplastic Agents