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Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903) (HCHTOG1903)

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Paclitaxel, Cisplatin
neoadjuvant chemoradiation therapy
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring esophageal squamous cell carcinoma, neoadjuvant chemotherapy, neoadjuvant chemoradiation therapy, randomized controlled, survival

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • cT2-T4aN+M0 or cT3-4aN0M0 (8th TNM staging system) thoracic esophageal squamous cell carcinoma
  • No metastatic cervical lymph node
  • No anti-cancer treatment
  • No contraindication for esophagectomy
  • No contraindication for chemotherapy or chemoradiation therapy
  • PS score 0-1
  • Written consent is obtained

Exclusion Criteria:

  • Previous cancer treatment history
  • Concurrent cancer disease in other site
  • Tumor length ≥8cm
  • Tumor width ≥5cm
  • Need continuous steroid treatment
  • Cardiac infarction in 6 months
  • Psychotic patient
  • Can not achieve R0 resection
  • Gastric tube can not be used for reconstruction after esophagectomy
  • Pregnant woman

Sites / Locations

  • Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chemotherapy group

Chemoradiation group

Arm Description

Patients in this group will receive neoadjuvant chemotherapy.

Patients in this group will receive neoadjuvant chemoradiation therapy.

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

disease-free survival
pathological complete response
adverse events
postoperative complications

Full Information

First Posted
October 20, 2019
Last Updated
August 8, 2022
Sponsor
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04138212
Brief Title
Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)
Acronym
HCHTOG1903
Official Title
Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Controlled Clinical Trial (HCHTOG1903)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2019 (Actual)
Primary Completion Date
December 21, 2023 (Anticipated)
Study Completion Date
December 21, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Multimodal treatment combining surgery with chemotherapy and/or radiotherapy is necessary to improve the chances of survival in patients with locally advanced thoracic esophageal cancer. However, there is no consensus about the neoadjuvant treatment for resectable locally advanced esophageal squamous cell carcinoma. The aim of current randomized controlled clinical trail is to investigate the impact of neoadjuvant chemotherapy plus surgery and neoadjuvant chemoradiation therapy plus surgery on overall survival for patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 456 patients with locally advanced esophageal squamous cell carcinoma in 3 years. Eligible patients will be randomized into neoadjuvant chemotherapy group (paclitaxel 175mg/m2 plus cisplatin 75mg/m2, q21d, 2 cycles) or neoadjuvant chemoradiation group (41.4Gy, 1.8Gy*23d plus paclitaxel 50mg/m2 plus carboplatin AUC=2, q1w, 5 cycles). The primary endpoint is 5 year overall survival and the secondary endpoints include 5 year disease-free survival, adverse events, pathologic complete response, postoperative complications, quality of life. The biomarkers predicting the sensitivity of neoadjuvant therapy will be explored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
esophageal squamous cell carcinoma, neoadjuvant chemotherapy, neoadjuvant chemoradiation therapy, randomized controlled, survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
456 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive neoadjuvant chemotherapy.
Arm Title
Chemoradiation group
Arm Type
Experimental
Arm Description
Patients in this group will receive neoadjuvant chemoradiation therapy.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel, Cisplatin
Intervention Description
Paclitaxel 175mg/m2 plus Cisplatin 75mg/m2, q21d, 2 cycles
Intervention Type
Radiation
Intervention Name(s)
neoadjuvant chemoradiation therapy
Intervention Description
Paclitaxel 50mg/m2 plus Carboplatin AUC=2, q1w, 5 cycles; 41.4Gy, 1.8Gy/d*23
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5 year
Secondary Outcome Measure Information:
Title
disease-free survival
Time Frame
5 year
Title
pathological complete response
Time Frame
3 months
Title
adverse events
Time Frame
3 months
Title
postoperative complications
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cT2-T4aN+M0 or cT3-4aN0M0 (8th TNM staging system) thoracic esophageal squamous cell carcinoma No metastatic cervical lymph node No anti-cancer treatment No contraindication for esophagectomy No contraindication for chemotherapy or chemoradiation therapy PS score 0-1 Written consent is obtained Exclusion Criteria: Previous cancer treatment history Concurrent cancer disease in other site Tumor length ≥8cm Tumor width ≥5cm Need continuous steroid treatment Cardiac infarction in 6 months Psychotic patient Can not achieve R0 resection Gastric tube can not be used for reconstruction after esophagectomy Pregnant woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haibo Sun
Phone
+8615188301091
Email
sunny-haipo@hotmail.com
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haibo Sun
Phone
+8615188301091
Email
sunny-haipo@hotmail.com
First Name & Middle Initial & Last Name & Degree
Haibo Sun

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)

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