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OpenTrials
Completed

NCT Number: NCT02133612

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Xiao Lv

Beijing, Beijing Municipality, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Paclitaxel Injection, Beijing Union Pharmaceutical Factory

Primary outcomes

  1. 3 year overall survival

    Time frame: 5 year

Secondary outcomes

  1. 3 year disease-free survival

    Time frame: 5 year

Other outcomes

  1. Number of Participants with Adverse Events

    Time frame: 5 year

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2014
First posted
May 8, 2014
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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