A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma

NCT ID: NCT01171781

Last Updated: 2010-07-28

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

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-06-30

Brief Summary

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The study try to show the weekly cisplatin based CCRT is not inferior to 3-weekly cisplabe based CCRT in terms of 3-yr progression free survival rate in advanced nasopharyngeal carcinoma

Detailed Description

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Conditions

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Nasophayngeal Carcinoma Between Stage II and IVb

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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3 weekly CDDP based CCRT

radiation (conventioal or IMRT) with 3 cycles of 3-weekly cisplatin

Group Type ACTIVE_COMPARATOR

cisplatin (3 weekly)

Intervention Type DRUG

radiation with cisplatin (100mg/m2) on D1,D22,D43 and followed by adjuvant chemotherapy (3 cycles of FP)

weekly cisplatin based CCRT

radiation (conventional or IMRT) with 7 cycles of weekly cisplatin therapy

Group Type EXPERIMENTAL

cisplatin (weekly)

Intervention Type DRUG

radiation with 7 cycles of cisplatin (40mg/m2) on D1,8,15,22,29,36,43, and followed by adjuvant chemothrapy (FP X3)

Interventions

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cisplatin (3 weekly)

radiation with cisplatin (100mg/m2) on D1,D22,D43 and followed by adjuvant chemotherapy (3 cycles of FP)

Intervention Type DRUG

cisplatin (weekly)

radiation with 7 cycles of cisplatin (40mg/m2) on D1,8,15,22,29,36,43, and followed by adjuvant chemothrapy (FP X3)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* histologically confirmed nasopharyngeal carcinoma age of 18 years or over stage II \~ IVb no history of chemotherapy, radiotherapy, or immunotherapy for NPC with measurable lesion based on RECIST 1.1 ECOG PS 0 \~2 good organ function (liver, renal, hematologic)

Exclusion Criteria

* active infectious disease requiring antibiotics uncontrolled heart disease pregnancy and on feeding state history of other malignancy within 5 years before enrollment, except for well treated non-melanomatous skin cancer, in situ cervical cancer, thyroid cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Myung-Ju Ahn, M.D, Ph.D.

Role: CONTACT

822-3410-3438

Facility Contacts

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Myung-Ju Ahn, M.D., Ph.D.

Role: primary

822-3410-3438

Other Identifiers

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2009-09-037

Identifier Type: -

Identifier Source: org_study_id

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