Trial Outcomes & Findings for Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy (NCT NCT00700440)

NCT ID: NCT00700440

Last Updated: 2010-03-26

Results Overview

The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study. Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 100 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2010-03-26

Participant Flow

2008-7-1 ~ 2009-4-3

Participant milestones

Measure	Cetuximab 400mg/m\^2 intravenous infusion one week before radiotherapy, then 250mg/m\^2 intravenous infusion weekly during radiotherapy
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy

Baseline characteristics by cohort

Measure	Cetuximab n=100 Participants 400mg/m\^2 intravenous infusion one week before radiotherapy, then 250mg/m\^2 intravenous infusion weekly during radiotherapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	43 Years n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Region of Enrollment China	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.

Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.

Outcome measures

Measure	Cetuximab n=100 Participants 400mg/m\^2 intravenous infusion one week before radiotherapy, then 250mg/m\^2 intravenous infusion weekly during radiotherapy
3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy	100 participants with loco-regional control

SECONDARY outcome

Timeframe: 5 year

Outcome measures

Outcome data not reported

Adverse Events

Cetuximab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lu Tai-xiang

Cancer Center, Sun Yat-sen University

Phone: 86-20-87343372

Email: lutx@mail.sysu.edu.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60