NCT02448979

Brief Summary

Esophageal carcinoma is an aggressive malignant disease with poor prognosis. Surgical resection remains the most effective method for this malignancy. Although different approaches have been studied for the surgical resection of thoracic esophageal cancer, little evidence has been achieved due to lack of large scale multicenter randomized trials with regard to this issue: whether left transthoracic approach or right transthoracic approach is the optimal surgical approach for treating middle and lower thoracic esophageal cancer without upper mediastinal lymph node metastasis. The purpose of this study is to compare the postoperative local recurrence rate and long-term outcome of esophagectomy through left and right transthoracic approach in the middle and lower thoracic esophageal cancer patients without preoperative upper mediastinal lymph node metastasis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

2.9 years

First QC Date

May 8, 2015

Last Update Submit

May 17, 2015

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Long term survival

    5 years

Secondary Outcomes (3)

  • Disease free survival

    5 years

  • Degree of lymph node dissection

    3 years

  • Postoperative complications

    3 years

Study Arms (2)

Left thoracotomy

ACTIVE COMPARATOR

Esophagectomy through left side transthoracic approach, with esophagogastric anastomosis above aortic arch and two-field lymphadenectomy (thoracic and abdominal lymph node)

Procedure: Left thoracotomy

Right thoracotomy

ACTIVE COMPARATOR

Esophagectomy through right side transthoracic approach, with esophagogastric anastomosis above azygos vain arch or on the top of chest cavity and two-field lymphadenectomy (thoracic and abdominal lymph node)

Procedure: Right thoracotomy

Interventions

Left thoracotomyPROCEDURE

Transthoracic approach is the surgical procedure including the open and minimally invasive thoracotomy.

Left thoracotomy
Right thoracotomyPROCEDURE

Transthoracic approach is the surgical procedure including the open and minimally invasive thoracotomy.

Right thoracotomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically proved squamous cell esophageal cancer without any previous anti-tumor therapy;
  • The preoperative clinical TNM stage: cT1b-3N0-1M0;
  • Adequate function of heart, lung, liver, brain and kidney, which can tolerate esophagectomy either through left or right thoracotomy;
  • Without any preoperative distant metastases confirmed by preoperative examination such as chest and abdominal CT, brain MRI and bone scan or PET-CT;
  • No evidence showing suspicious upper mediastinal lymph node metastasis (short diameter of LN \<0.8cm or shortest diameter / longest diameter \<0.65) by the thoracic and abdominal CT and endoscopic ultrasonography(EUS).
  • Willing to participate the clinical trial and sign informed consent before being enrolled into clinical trail.

You may not qualify if:

  • Non-squamous cell esophageal carcinoma or has any previous anti-cancer therapy before surgery;
  • The preoperative clinical TNM stage reaches: N2-3 or M1;
  • Inadequate cardiopulmonary, liver, brain and kidney function for tolerating the esophagectomy ;
  • Previous history of malignancy;
  • Unwilling to participate the clinical trial and refuse to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

  • Mao YS, Gao SG, Li Y, Hao AL, Liu JF, Li XF, Rong TH, Fu JH, Ma JQ, Xu MQ, Zhang RQ, Xiao GM, Fu XN, Chen KN, Mao WM, Liu YY, Liu HX, Zhang ZR, Fang Y, Fu DH, Wei XD, Yuan LG, Muhammad S, Wei WQ, Chiu PW, Lloyd S, Schlottmann F, Meredith K, Pimiento JM, Gao YB, He J. Efficacy and safety of esophagectomy via left thoracic approach versus via right thoracic approach for middle and lower thoracic esophageal cancer: a multicenter randomized clinical trial (NST1501). Ann Transl Med. 2022 Aug;10(16):904. doi: 10.21037/atm-22-3810.

    PMID: 36111056DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 20, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2019

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

CN(1)