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

Samsung Medical Center

Status and phase: Unknown; Phase 2

Conditions: Nasophayngeal Carcinoma Between Stage II and IVb

Treatments: Drug: cisplatin (3 weekly); Drug: cisplatin (weekly)

Study type: Interventional

Funder types: Other

Identifiers

NCT01171781

2009-09-037

Details and patient eligibility

About

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

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

3 weekly CDDP based CCRT

Active Comparator group

Description:

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

Treatment:

Drug: cisplatin (3 weekly)

weekly cisplatin based CCRT

Experimental group

Description:

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

Treatment:

Drug: cisplatin (weekly)