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

NCT02133612 | Completed Phase 2

• 1 other identifier: CH-GI-026
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

esophageal cancer; adjuvant chemotherapy; esophageal surgery; paclitaxel; cisplatin

Outcome Measures

Primary Outcomes (1)

• 3 year overall survival

  5 year

Secondary Outcomes (1)

• 3 year disease-free survival

  5 year

Other Outcomes (1)

• Number of Participants with Adverse Events

  5 year

Study Arms (1)

single arm paclitaxel and cisplatin

EXPERIMENTAL

Drug: paclitaxel; cisplatin

Interventions

paclitaxel; cisplatin DRUG

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.

Also known as: Paclitaxel Injection, Beijing Union Pharmaceutical Factory

single arm paclitaxel and cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Xiao Lv

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

TP protocol; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jing Huang, M.D

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 8, 2014
• Study Start: December 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2014
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

CN (1)