Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133612
• Other study ID #: CH-GI-026
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2014
• Last updated: April 13, 2015
• Start date: December 2007
• Est. completion date: May 2014

Study information

• Verified date: April 2015
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• paclitaxel; cisplatin
The adjuvant chemotherapy regimen consisted of paclitaxel 150mg/m2 intravenously (IV) over 3 hours on day 1, followed by cisplatin 50mg/m2 IV on day 2 every 14 days for 4 to 6 cycles.

Locations

Country	Name	City	State
China	Xiao Lv	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Adverse Events		5 year	Yes
Primary	3 year overall survival		5 year	Yes
Secondary	3 year disease-free survival		5 year	Yes