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Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer

This study is currently recruiting participants.
Verified September 2011 by Zhejiang Cancer Hospital
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01463501
First received: August 30, 2011
Last updated: May 11, 2013
Last verified: September 2011
History of Changes
  Purpose

This is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer.


Condition Intervention Phase
Esophageal Cancer
 Other: Neoadjuvant chemoradiotherapy
Other: Adjuvant chemoradiotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and Carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and Carboplatin) for Esophageal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • Scores of Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assess the quality of life based on FACT-E.

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assess the safety and tolerability based on NCI CTC V4.0


Secondary Outcome Measures:
  • Disease-free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Three years disease free survival will be evaluated.

  • Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Three years overall survival will be evaluated.


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neoadjuvant Treatment
Preoperative chemotherapy/radiotherapy
 Other: Neoadjuvant chemoradiotherapy
Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.
Other Name: Neoadjuvant Treatment
Experimental: Adjuvant Treatment
Postoperative chemotherapy/radiotherapy
 Other: Adjuvant chemoradiotherapy
Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.
Other Name: Adjuvant Treatment

Detailed Description:

Patient Population:

Thoracic esophageal cancer able to tolerate tri-modality therapy; Clinical stage T3-4, N0-1, M0

Scheme:

Patients are randomized to 2 arms:

Arm A:

Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.

Arm B:

Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (> 20cm from the incisors) or gastroesophageal junction are included.
  • No distant metastases (M0).
  • Patients will be stratified by stage (clinical N0 versus clinical N1).
  • Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy.
  • Resectable mediastinal nodes are eligible.
  • No prior chemotherapy for this malignancy.
  • No prior radiotherapy that would overlap the field(s) treated in this study.
  • Patients with other malignancies are eligible only if > 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer.
  • Age > 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon.

Exclusion Criteria:

  • Cancers of the cervical esophagus (< 20 cm are excluded).
  • Tumours that have > 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible.
  • Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible.
  • Patients with biopsy proven metastatic celiac nodes are ineligible.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463501

Contacts
Contact: Weimin Mao, MD. +86-571-88122032 maowmzj1218@163.com
Contact: Yaping Xu, MD. +86-571-88122082 xuyaping1207@gmail.com

Locations
China, Zhejiang
Zhejiang Cancer Hospital Not yet recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Weimin Mao, MD.     +86-571-88122032     maowmzj1218@163.com    
Contact: Yaping Xu, MD     +86-571-88122082     xuyaping1207@gmail.com    
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Yaping Xu, MD     +86 0571 88122082     xuyaping1207@gmail.com    
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Principal Investigator: Weimin Mao, MD Zhejiang Cancer Hospital
  More Information

No publications provided

Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01463501     History of Changes
Other Study ID Numbers: ZhejiangCH09
Study First Received: August 30, 2011
Last Updated: May 11, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Zhejiang Cancer Hospital:
Esophageal cancer
Resectable
Neoadjuvant chemoradiotherapy
Adjuvant chemoradiotherapy

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Adjuvants, Immunologic
Carboplatin
 Paclitaxel
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 22, 2013