Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer

Phase 2

• Conditions: Esophageal Cancer
• Interventions: Other: Neoadjuvant chemoradiotherapy; Other: Adjuvant chemoradiotherapy

• Registration Number: NCT01463501
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Study Timeline

• Study First Submitted: 2011-08-30
• Status Verified: 2011-09
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-29
• Study First Posted: 2011-11-02
• Last Update Submitted: 2013-05-11
• Last Update Posted: 2013-05-14
• Primary Completion: 2013-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoadjuvant Treatment	Neoadjuvant chemoradiotherapy	Preoperative chemotherapy/radiotherapy
Adjuvant Treatment	Adjuvant chemoradiotherapy	Postoperative chemotherapy/radiotherapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Disease-free Survival	3 years	Three years disease free survival will be evaluated.
Overall Survival	3 years	Three years overall survival will be evaluated.

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China