Detection of Circulating Tumor Tells as The Guidance of the Neoadjuvant Chemotherapy of Esophageal Cancer

NCT03005314 | Unknown DMC

• 1 other identifier: 2016YFC0106005
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Esophageal carcinoma is a common digestive system tumor, with number of deaths ranking No. 4 in malignant tumors. Esophageal squamous cell carcinoma in stage Ⅱ, III is the most common in China. The esophageal cancer during these stages is no longer localized lesions, and cancer will be transferred to other organs of the body through blood transmission, leading to tumor metastasis, which is the main cause of the patients' death. The tumor cells invade the surrounding tissues of primary tumor cells and enter the blood and lymphatic system, thus the circulating tumor cells (CTC) is formed and transported to a distal tissue, then effusing, adapting to the new microenvironment and finally forming metastases through the process of seeding, proliferation and colonization. Recently, the controversy of surgical treatment of esophageal carcinoma is concentrated on the neoadjuvant therapy during perioperative period. NCCN guideline of 2015 recommended that patients with esophageal squamous cell carcinoma in T1b, N + and T2-T4a, N0-N + may consider preoperative neoadjuvant therapy, but its supporting literature (David Cunningham 2006, Marc Ychou 2011 and P. van Hagen, 2013) includes patients with pathology of the type adenocarcinoma. The esophageal cancer treatment guidelines of Japan 2015 adopted the opinion of NCCN Guidelines, and recommended neoadjuvant chemotherapy and radical surgery as the standard treatment for stage II and III esophageal cancer patients based on the results of randomized controlled clinical trial JCOG9907. However, the guidelines also pointed out that the role of neoadjuvant chemotherapy for resectable T1-3N0-1M0 cancers remains unclear according to the results of some meta-analysis. The investigators choose the detection of peripheral venous blood CTCs and the disease-free survival as the main index, to compare the treatment effect of patients, those received neoadjuvant therapy, surgery and those received directly surgery, postoperative chemotherapy with esophageal squamous cell carcinoma in stage Ⅱ, III by means of evidence-based medicine; Define the indication of neoadjuvant chemotherapy in the treatment of esophageal squamous cell carcinoma in stage Ⅱ, III; Draft the solution to evaluate the treatment effect of neoadjuvant chemotherapy to esophageal cancer in stage Ⅱ, III, and the indication of neoadjuvant chemotherapy by test the peripheral venous blood CTCs and join the Chinese clinical guideline.

Conditions

Esophageal Cancer TNM Staging Primary Tumor (T) T3

Outcome Measures

Primary Outcomes (1)

• progression- free survival

  survival without recurrence or metastasis

  through study completion, an average of 2-3 year

Secondary Outcomes (1)

• overall survival

  through study completion, an average of 5 year

Study Arms (2)

Surgery

OTHER

Postoperative chemotherapy group

Procedure: Surgery

Chemotherapy

OTHER

Preoperative chemotherapy group

Procedure: chemotherapy

Interventions

chemotherapy PROCEDURE

chemotherapy before surgery

Chemotherapy

Surgery PROCEDURE

chemotherapy after surgery

Surgery

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically proven squamous cell carcinoma of the thoracic esophagus;clinical stage II or III excluding T4 disease
• resectable disease; ECOG performance status of 0 to 2
• no previous chemo- or radiotherapy for any malignancies
• sufficient organ function.

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead
• Shandong Cancer Hospital and Institute: collaborator
• Wuhan YZY Medical Science and Technology Co., Ltd.: collaborator

Study Sites (1)

The Second Hospital of Shandong University

Jinan, Shandong, 250033, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xiaogang Zhao, Doctor

  The Second Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunpeng Zhao, doctor

CONTACT

+8618766188692; zyp_baggio@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice- director

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: December 29, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)