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Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)

Primary Purpose

Esophagus Cancer, Esophageal Squamous Cell Carcinoma, Chemoradiotherapy

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Paclitaxel
Carboplatin
Radiotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagus Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Joined the study voluntarily and signed informed consent form;
  • Age 18-75;
  • ECOG 0-2;
  • Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
  • The operative incision healed well;
  • T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);
  • No radiotherapy, chemotherapy or other treatments pre (post) surgery;
  • PS ECOG 0-2;
  • Life expectancy of more than 3 months;
  • Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 109/L;
  • Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL< 1.5 x ULN;
  • Renal function: creatinine < 1.5 x ULN
  • No immuno-deficiency;
  • Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

  • Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis;
  • Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
  • Participation in other interventional clinical trials within 30 days;
  • Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
  • Drug addiction, Alcoholism or AIDS;
  • Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
  • Unsuitable to be enrolled in the trial in the opinion of the investigators.

Sites / Locations

  • Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Concurrent chemoradiotherapy group

Arm Description

Interventions: Chemotherapy: Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw*5 Radiotherapy: A total dose of 50.4Gy will be delivered in 28 fractions at 1.8Gy/fraction, 5 fractions per week in 6 weeks. The CTV encompassed the bilateral supraclavicular, superior mediastinal, and subcarinal regions.

Outcomes

Primary Outcome Measures

Local control rate

Secondary Outcome Measures

Overall survival

Full Information

First Posted
February 19, 2021
Last Updated
August 1, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04764227
Brief Title
Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)
Official Title
Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 30, 2020 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

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
The purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer, Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Radiation Therapy, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Concurrent chemoradiotherapy group
Arm Type
Experimental
Arm Description
Interventions: Chemotherapy: Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw*5 Radiotherapy: A total dose of 50.4Gy will be delivered in 28 fractions at 1.8Gy/fraction, 5 fractions per week in 6 weeks. The CTV encompassed the bilateral supraclavicular, superior mediastinal, and subcarinal regions.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
carboplatin AUC=2, ivgtt, d1, qw*5
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
1.8Gy/d, d1-5/week, 28Fx
Primary Outcome Measure Information:
Title
Local control rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years

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: Joined the study voluntarily and signed informed consent form; Age 18-75; ECOG 0-2; Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection; The operative incision healed well; T3-4N0M0, T1-4N1-3M0 (according to AJCC2009); No radiotherapy, chemotherapy or other treatments pre (post) surgery; PS ECOG 0-2; Life expectancy of more than 3 months; Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 109/L; Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL< 1.5 x ULN; Renal function: creatinine < 1.5 x ULN No immuno-deficiency; Use of an effective contraceptive for adults to prevent pregnancy. Exclusion Criteria: Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis; Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years; Participation in other interventional clinical trials within 30 days; Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives; Drug addiction, Alcoholism or AIDS; Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior; Unsuitable to be enrolled in the trial in the opinion of the investigators.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuaile Zhao
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)

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