Trial Outcomes & Findings for Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma (NCT NCT00815308)

Results Overview

The overall response rate was defined as the numbers of patients with a complete response (CR) or partial response (PR). CR was defined as no target lesion at follow-up computed tomography scan and barium swallow examination 3-6 weeks after completion of chemo-radiation. PR was defined at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

1 to 3 month after therapy

Results posted on

2011-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	Cetuximab, Concurrent Chemo-radiotherapy Cetuximab, injection, loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m\^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m\^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
Overall Study STARTED	55
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Cetuximab, Concurrent Chemo-radiotherapy Cetuximab, injection, loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m\^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m\^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
Overall Study Adverse Event	4
Overall Study Withdrawal by Subject	0
Overall Study Protocol Violation	6

Baseline Characteristics

Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetuximab, Concurrent Chemo-radiotherapy n=55 Participants Cetuximab, injection, loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m\^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m\^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=93 Participants
Age, Categorical >=65 years	9 Participants n=93 Participants
Age Continuous	57.68 years STANDARD_DEVIATION 6.93 • n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	45 Participants n=93 Participants
Region of Enrollment China	55 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 to 3 month after therapy

The overall response rate was defined as the numbers of patients with a complete response (CR) or partial response (PR). CR was defined as no target lesion at follow-up computed tomography scan and barium swallow examination 3-6 weeks after completion of chemo-radiation. PR was defined at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Cetuximab, Concurrent Chemo-radiotherapy n=55 Participants Cetuximab, injection, loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m\^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m\^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
Number of Participants With Overall Response Rate (RR)	44 participants

SECONDARY outcome

Timeframe: Every week during treatment and 1 month after therapy

All patients were regularly monitored for possible adverse events, which were graded according to National Cancer Institute Common Toxicity Criteria version 3.0.

Outcome measures

Outcome measures
Measure	Cetuximab, Concurrent Chemo-radiotherapy n=55 Participants Cetuximab, injection, loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m\^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m\^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
Number of Participants With Toxicity	55 participants

SECONDARY outcome

Timeframe: 1 year from the date of diagnosis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 year from the date of diagnosis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Recurrence or metastasis from the date of diagnosis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 07/29/2010-09/30/2010

DNA was extracted from tumor specimens.Screened for the presence of KRAS codon 12 and 13 mutations using a PCR clamping and melting curve technique. PCR amplification of the wild-type KRAS sequence was suppressed in this process by the incorporation in the reaction mix of a locked nucleic-acid oligomer16 spanning codons 12 and 13 of the KRAS gene. Post-PCR hybridization and melting curve analysis using fluorescently tagged oligonucleotides incorporated in the original PCR reaction permitted the identification and discrimination of distinct KRAS codon 12 and 13 missense mutations.

Outcome measures

Outcome measures
Measure	Cetuximab, Concurrent Chemo-radiotherapy n=55 Participants Cetuximab, injection, loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m\^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m\^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
Number of Participants With K-ras Gene Mutation	53 participants

Adverse Events

Cetuximab, Concurrent Chemo-radiotherapy

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cetuximab, Concurrent Chemo-radiotherapy n=55 participants at risk Cetuximab, injection, loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m\^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m\^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
Injury, poisoning and procedural complications esophago-tracheal fistula	1.8% 1/55 • Number of events 1
Infections and infestations Pneumonia	1.8% 1/55 • Number of events 1

Other adverse events

Other adverse events
Measure	Cetuximab, Concurrent Chemo-radiotherapy n=55 participants at risk Cetuximab, injection, loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m\^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m\^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
Hepatobiliary disorders Hepatic Functional Lesion	3.6% 2/55 • Number of events 2
Blood and lymphatic system disorders Granulocytopenia	32.7% 18/55 • Number of events 18
Skin and subcutaneous tissue disorders Skin Eruption	1.8% 1/55 • Number of events 1
Blood and lymphatic system disorders granlopenia	7.3% 4/55 • Number of events 4
Skin and subcutaneous tissue disorders radiodematitis	7.3% 4/55 • Number of events 4
Skin and subcutaneous tissue disorders mucositis	12.7% 7/55 • Number of events 7
Injury, poisoning and procedural complications radioacitvity esophagitis	3.6% 2/55 • Number of events 2

Additional Information

Jinming Yu

Shandong Cancer Hospital and Institute

Phone: 86-531-87984729

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place