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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

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

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

NCT ID

NCT03381651

First Posted

December 18, 2017

Last Updated

March 12, 2022

Sponsor

Zhejiang Cancer Hospital

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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

xyangyang1987@126.com

First Name & Middle Initial & Last Name & Degree

Danhong Zhang, M.D

Phone

0571-88128182

zhangdh@zjcc.org.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

21684205

Citation

Sjoquist KM, Burmeister BH, Smithers BM, Zalcberg JR, Simes RJ, Barbour A, Gebski V; Australasian Gastro-Intestinal Trials Group. Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol. 2011 Jul;12(7):681-92. doi: 10.1016/S1470-2045(11)70142-5. Epub 2011 Jun 16.

Results Reference

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PubMed Identifier

26254683

Citation

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Citation

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PubMed Identifier

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Citation

Gebski V, Burmeister B, Smithers BM, Foo K, Zalcberg J, Simes J; Australasian Gastro-Intestinal Trials Group. Survival benefits from neoadjuvant chemoradiotherapy or chemotherapy in oesophageal carcinoma: a meta-analysis. Lancet Oncol. 2007 Mar;8(3):226-34. doi: 10.1016/S1470-2045(07)70039-6.

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PubMed Identifier

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Citation

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Citation

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Different Radiation Dose of Neoadjuvant Chemoradiation for Resectable Thoracic Esophageal Squamous Carcinoma

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