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Clinical Trials/NCT02133612
NCT02133612CompletedPhase 2

Phase 2 Study of Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Patients With Advanced Esophageal Cancer

Chinese Academy of Medical Sciences1 site in 1 country43 target enrollmentStarted: December 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
43
Locations
1
Primary Endpoint
3 year overall survival
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.

  • Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.
  • No standard postoperative adjuvant chemotherapy has ever been established.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •ability to give informed consent
  • •histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins
  • •node-positive and pathologic stage M0 .
  • •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • •Patients were enrolled 4 to 10 weeks after surgery.
  • •Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin<2 times of upper normal institutional limits.

Exclusion Criteria

  • •prior chemotherapy or concurrent radiation therapy before esophagectomy
  • •R1 or R2 resection
  • •clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination

Arms & Interventions

single arm paclitaxel and cisplatin

Experimental

Intervention: paclitaxel; cisplatin (Drug)

Outcomes

Primary Outcomes

3 year overall survival

Time Frame: 5 year

Secondary Outcomes

  • 3 year disease-free survival(5 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jing Huang

M.D

Chinese Academy of Medical Sciences

Study Sites (1)

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