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Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01463501
First Posted: November 2, 2011
Last Update Posted: May 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • Scores of Quality of life [ Time Frame: 1 year ]
    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 ]
    Assess the safety and tolerability based on NCI CTC V4.0


Secondary Outcome Measures:
  • Disease-free Survival [ Time Frame: 3 years ]
    Three years disease free survival will be evaluated.

  • Overall Survival [ Time Frame: 3 years ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01463501     History of Changes
Other Study ID Numbers: ZhejiangCH09
First Submitted: August 30, 2011
First Posted: November 2, 2011
Last Update Posted: May 14, 2013
Last Verified: September 2011

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

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action