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

Esophageal Cancer Clinical Trial

Official title:

Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma: A Randomized Phase 3 Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02461043
• Other study ID #: CH-GI-046
• Status: Recruiting
• Phase: Phase 3
• First received: May 30, 2015
• Last updated: August 29, 2015
• Start date: April 2015
• Est. completion date: December 2023

Study information

• Verified date: August 2015
• Source: Chinese Academy of Medical Sciences
• Contact: Jing Huang
• Phone: 8610-87788102
• 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: Recruiting
• Enrollment: 386
• Est. completion date: December 2023
• Est. primary completion date: December 2020
• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• 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.

Radiation:
• radiation
radiation

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	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	5 year overall survival		8 years	Yes
Primary	3 year relapse free survival		5 years	Yes
Secondary	3 year overall survival		5 years	Yes