Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01463501
• Other study ID #: ZhejiangCH09
• Status: Recruiting
• Phase: Phase 2
• First received: August 30, 2011
• Last updated: May 11, 2013
• Start date: October 2011
• Est. completion date: December 2016

Study information

• Verified date: September 2011
• Source: Zhejiang Cancer Hospital
• Contact: Weimin Mao, MD.
• Phone: +86-571-88122032
• Email: maowmzj1218[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Other:
• Neoadjuvant chemoradiotherapy
Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.
• Adjuvant chemoradiotherapy
Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores of Quality of life	Assess the quality of life based on FACT-E.	1 year	No
Primary	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	No
Secondary	Disease-free Survival	Three years disease free survival will be evaluated.	3 years	No
Secondary	Overall Survival	Three years overall survival will be evaluated.	3 years	Yes