Weekly Cisplatin or Nedaplatin Concurrent With Intensity-modulated Radiation Therapy in Nasopharyngeal Carcinoma

NCT ID: NCT02301208

Last Updated: 2014-12-08

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

2014-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

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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Low dose cisplatin arm

concurrent chemotherapy: cisplatin 20mg/m2,weekly,for 6 cycles during radiotherapy

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

Cisplatin combine with IMRT

High dose cisplatin arm

concurrent chemotherapy: cisplatin 30mg/m2,weekly,for 6 cycles during radiotherapy

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

Cisplatin combine with IMRT

Low dose nedaplatin arm

concurrent chemotherapy: nedaplatin 20mg/m2,weekly,for 6 cycles during radiotherapy

Group Type EXPERIMENTAL

Nedaplatin

Intervention Type DRUG

Nedaplatin combine with IMRT

High dose nedaplatin arm

concurrent chemotherapy: nedaplatin 30mg/m2,weekly,for 6 cycles during radiotherapy

Group Type EXPERIMENTAL

Nedaplatin

Intervention Type DRUG

Nedaplatin combine with IMRT

Interventions

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Nedaplatin

Nedaplatin combine with IMRT

Intervention Type DRUG

Cisplatin

Cisplatin combine with IMRT

Intervention Type DRUG

Other Intervention Names

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NDP PDD DDP CDDP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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He Xia

OTHER

Sponsor Role lead

Responsible Party

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He Xia

Jiangsu Cancer Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Li Yin, M.D. Ph.D.

Role: CONTACT

Phone: +8613913909043

Email: [email protected]

Pengwei Yan, M.M.

Role: CONTACT

Phone: +8613815888775

Email: [email protected]

Other Identifiers

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JiangsuCIH

Identifier Type: -

Identifier Source: org_study_id