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Different Radiation Dose of Neoadjuvant Chemoradiation for Resectable Thoracic Esophageal Squamous Carcinoma (Neo-DRATEC)

Primary Purpose

Esophageal Carcinoma, Neoadjuvant Chemoradiotherapy, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation
Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Carcinoma focused on measuring Radiation dose

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age:18-70 years

Histologically verified squamous carcinoma of the thoracic esophagus.

Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations.

Tumors should be resectable or potentially resectable and without distant metastasis, as assessed before neoadjuvant CRT, including clinical stage T2-4N0M0 or T1-4N1M0 according to the 6th AJCC system.

Joined the study voluntarily and signed informed consent form

No surgical contraindications

No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥10 g/dL, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≤ 2.5 x ULN, creatinine≤1.5 x ULN

Exclusion Criteria:

Cervical esophageal cancer (The upper end of the lesion is in the esophagus of the cervical segment).

Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy) proven metastatic supraclavicular or celiac nodes are ineligible.

Invasion of the tracheobronchial tree or aorta

Tracheoesophageal fistula

Concurrent pregnancy or lactation

Severe diabetes mellitus with poor blood glucose control

History of a second malignancy

Patients being unable to undergo esophageal reconstruction with gastric tube, due to prior surgery.

Patients undergoing esophageal reconstruction with jejunum.

Patients have allergy reaction or contraindications to taxanes.

Sites / Locations

  • Zhejiang Cancer Hospital
  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation

Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation

Arm Description

Neoadjuvant chemoradiation: RT: 50.4Gy/28F/5.6W; CT: paclitaxel 50mg/m2 d1, qw + CBP AUC2 d1, qw, weekly for 6 wks; Surgery: 4-6 weeks after nCRT

Neoadjuvant chemoradiation: RT: 41.4Gy/23F/4.6W; CT: paclitaxel 50mg/m2 d1, qw + CBP AUC2 d1, qw, weekly for 5 wks; Surgery: 4-6 weeks after nCRT

Outcomes

Primary Outcome Measures

Progression free survival
Time from randomization to tumor progression or any deaths

Secondary Outcome Measures

R0 resection rate in each arm
no cancer cells seen microscopically at the resection margin
Complete pathological response rate
using the Chirieac grading system
Postoperative complications in each study arm
According to the NCI CTC3.0
Treatment failure pattern
including local recurrence or distant metastasis or both
Overall survival
by intention to treat and per protocol analyses in each study arm

Full Information

First Posted
December 18, 2017
Last Updated
March 12, 2022
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03381651
Brief Title
Different Radiation Dose of Neoadjuvant Chemoradiation for Resectable Thoracic Esophageal Squamous Carcinoma
Acronym
Neo-DRATEC
Official Title
Different Radiation Dose of Neoadjuvant Chemoradiation Followed By Surgery in Treating Patients With Locally Advanced, Resectable Thoracic Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
February 22, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Esophageal cancer is one of the most common cancers worldwide, while more than half new cases and deaths occurred in China. Surgery is the main curative treatment for this disease, the 5-year survival of EC remains poor, since most diseases are diagnosed at advanced stages. In last decades, several large clinical trials and meta-analyses have demonstrated that neo-adjuvant chemoradiotherapy followed by surgery can significantly increase the overall survival of patients with EC compared with surgery alone, while no effect of nCRT was apparent on postoperative health-related quality of life . However, the optimal radiation dose and surgery timing are still unknown. The investigators hypothesize that patients who receive higher dose (50.4Gy/28F) of neoadjuvant chemoradiation will have better pathologic response and progress-free survival compared to lower dose (41.4Gy/23F) of chemoradiation followed by surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Carcinoma, Neoadjuvant Chemoradiotherapy, Surgery
Keywords
Radiation dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation
Arm Type
Active Comparator
Arm Description
Neoadjuvant chemoradiation: RT: 50.4Gy/28F/5.6W; CT: paclitaxel 50mg/m2 d1, qw + CBP AUC2 d1, qw, weekly for 6 wks; Surgery: 4-6 weeks after nCRT
Arm Title
Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation
Arm Type
Active Comparator
Arm Description
Neoadjuvant chemoradiation: RT: 41.4Gy/23F/4.6W; CT: paclitaxel 50mg/m2 d1, qw + CBP AUC2 d1, qw, weekly for 5 wks; Surgery: 4-6 weeks after nCRT
Intervention Type
Radiation
Intervention Name(s)
Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation
Intervention Description
50.4Gy/28F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly
Intervention Type
Radiation
Intervention Name(s)
Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation
Intervention Description
41.4Gy/23F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly
Primary Outcome Measure Information:
Title
Progression free survival
Description
Time from randomization to tumor progression or any deaths
Time Frame
2 year
Secondary Outcome Measure Information:
Title
R0 resection rate in each arm
Description
no cancer cells seen microscopically at the resection margin
Time Frame
analysis is completed 4 weeks after surgery
Title
Complete pathological response rate
Description
using the Chirieac grading system
Time Frame
analysis is completed 4 weeks after surgery
Title
Postoperative complications in each study arm
Description
According to the NCI CTC3.0
Time Frame
30 and 90 days after surgery
Title
Treatment failure pattern
Description
including local recurrence or distant metastasis or both
Time Frame
2 year
Title
Overall survival
Description
by intention to treat and per protocol analyses in each study arm
Time Frame
5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age:18-70 years Histologically verified squamous carcinoma of the thoracic esophagus. Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations. Tumors should be resectable or potentially resectable and without distant metastasis, as assessed before neoadjuvant CRT, including clinical stage T2-4N0M0 or T1-4N1M0 according to the 6th AJCC system. Joined the study voluntarily and signed informed consent form No surgical contraindications No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥10 g/dL, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≤ 2.5 x ULN, creatinine≤1.5 x ULN Exclusion Criteria: Cervical esophageal cancer (The upper end of the lesion is in the esophagus of the cervical segment). Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy) proven metastatic supraclavicular or celiac nodes are ineligible. Invasion of the tracheobronchial tree or aorta Tracheoesophageal fistula Concurrent pregnancy or lactation Severe diabetes mellitus with poor blood glucose control History of a second malignancy Patients being unable to undergo esophageal reconstruction with gastric tube, due to prior surgery. Patients undergoing esophageal reconstruction with jejunum. Patients have allergy reaction or contraindications to taxanes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guoqin Qiu, M.D.
Phone
+86-571-88128182
Email
qiugq@zjcc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weimin Mao, M.D.
Organizational Affiliation
Zhejiang Caner Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoqin Qiu, M.D.
Phone
+86-571-88128182
Email
qiugq@zjcc.org.cn
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Yang, M.D
Phone
0571-88128182
Email
xyangyang1987@126.com
First Name & Middle Initial & Last Name & Degree
Danhong Zhang, M.D
Phone
0571-88128182
Email
zhangdh@zjcc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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21684205
Citation
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Different Radiation Dose of Neoadjuvant Chemoradiation for Resectable Thoracic Esophageal Squamous Carcinoma

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