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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03126708
Other study ID # ESCC-Cetuximab-PKU
Secondary ID
Status Recruiting
Phase Phase 2
First received April 12, 2017
Last updated January 3, 2018
Start date April 10, 2017
Est. completion date April 2020

Study information

Verified date January 2018
Source Peking University
Contact Zhihao Lu, MD
Phone 86-10-88196561
Email pppeirain@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an open-label, randomized, controlled trial. At the end of a 28-day screening period, all eligible subjects will be randomly assigned into treatment Arm A or B in a 1:1 ratio. Subjects in Arm A will receive a maximum of 6 cycles of chemotherapy (cisplatin plus paclitaxel) and cetuximab weekly in the absence of progressive disease (PD), as assessed by the Investigator, and unacceptable toxicity. After 6 cycles of treatment, subjects who derive clinical benefit will continue treatment with cetuximab as monotherapy until either PD or unacceptable toxicity. Subjects in Arm B will receive the same chemotherapy regimen as Arm A alone for a maximum of 6 cycles in the absence of PD and unacceptable toxicity.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date April 2020
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - Inclusion Criteria:

- Signed written informed consent.

- Older than 18 years of age.

- Histologically proven squamous cell carcinoma of the esophagus.

- Metastatic ESCC, not suitable for local-regional treatment.

- Presence of at least 1 measurable lesion according to RECIST version 1.1.

- ECOG performance status of 0 or 1.

- Adequate bone marrow, haptic, renal, metabolic function.

- Exclusion Criteria:

- Prior chemotherapy in the metastasis setting.

- Prior chemotherapy within 6 months before entering this study.

- Previous exposure to EGFR-targeted therapy.

- Known central nervous system metastasis and/or leptomeningeal disease.

- Subjects with any concurrent medical condition or disease that will potentially compromise the conduct of the trial at the discretion of investigator.

Study Design


Intervention

Drug:
cetuximab
cetuximab (EGFR monoclonal antibody) plus standard chemotherapy
cisplatin plus paclitaxel
Chemotherapy

Locations

Country Name City State
China Peking University Cancer Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary Overall Survival From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary overall response rate From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary Disease control rate From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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