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Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Neoadjuvant chemoradiotherapy
Adjuvant chemoradiotherapy
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal cancer, Resectable, Neoadjuvant chemoradiotherapy, Adjuvant chemoradiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhejiang Cancer Hospital
  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Neoadjuvant Treatment

Adjuvant Treatment

Arm Description

Preoperative chemotherapy/radiotherapy

Postoperative chemotherapy/radiotherapy

Outcomes

Primary Outcome Measures

Scores of Quality of life
Assess the quality of life based on FACT-E.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Assess the safety and tolerability based on NCI CTC V4.0

Secondary Outcome Measures

Disease-free Survival
Three years disease free survival will be evaluated.
Overall Survival
Three years overall survival will be evaluated.

Full Information

First Posted
August 30, 2011
Last Updated
May 11, 2013
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01463501
Brief Title
Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophageal cancer, Resectable, Neoadjuvant chemoradiotherapy, Adjuvant chemoradiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant Treatment
Arm Type
Experimental
Arm Description
Preoperative chemotherapy/radiotherapy
Arm Title
Adjuvant Treatment
Arm Type
Experimental
Arm Description
Postoperative chemotherapy/radiotherapy
Intervention Type
Other
Intervention Name(s)
Neoadjuvant chemoradiotherapy
Other Intervention Name(s)
Neoadjuvant Treatment
Intervention Description
Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.
Intervention Type
Other
Intervention Name(s)
Adjuvant chemoradiotherapy
Other Intervention Name(s)
Adjuvant Treatment
Intervention Description
Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.
Primary Outcome Measure Information:
Title
Scores of Quality of life
Description
Assess the quality of life based on FACT-E.
Time Frame
1 year
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Assess the safety and tolerability based on NCI CTC V4.0
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Disease-free Survival
Description
Three years disease free survival will be evaluated.
Time Frame
3 years
Title
Overall Survival
Description
Three years overall survival will be evaluated.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weimin Mao, MD.
Phone
+86-571-88122032
Email
maowmzj1218@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yaping Xu, MD.
Phone
+86-571-88122082
Email
xuyaping1207@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weimin Mao, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimin Mao, MD.
Phone
+86-571-88122032
Email
maowmzj1218@163.com
First Name & Middle Initial & Last Name & Degree
Yaping Xu, MD
Phone
+86-571-88122082
Email
xuyaping1207@gmail.com
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaping Xu, MD
Phone
+86 0571 88122082
Email
xuyaping1207@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer

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