Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer
• Intervention / Treatment: Other: Neoadjuvant chemoradiotherapy; Other: Adjuvant chemoradiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Yaping Xu, MD; Phone Number: +86 0571 88122082; Email: xuyaping1207@gmail.com
    • Hangzhou, Zhejiang, China, 310022
      • Not yet recruiting
      • Zhejiang Cancer Hospital
      • Contact: Weimin Mao, MD.; Phone Number: +86-571-88122032; Email: maowmzj1218@163.com
      • Contact: Yaping Xu, MD; Phone Number: +86-571-88122082; Email: xuyaping1207@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Adjuvant Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores of Quality of life	Assess the quality of life based on FACT-E.	1 year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Assess the safety and tolerability based on NCI CTC V4.0	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival	Three years disease free survival will be evaluated.	3 years
Overall Survival	Three years overall survival will be evaluated.	3 years

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Weimin Mao, MD, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 30, 2011
• First Submitted That Met QC Criteria: October 29, 2011
• First Posted (Estimate): November 2, 2011

Study Record Updates

• Last Update Posted (Estimate): May 14, 2013
• Last Update Submitted That Met QC Criteria: May 11, 2013
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Resectable; Esophageal cancer; Adjuvant chemoradiotherapy; Neoadjuvant chemoradiotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: ZhejiangCH09