search
Back to results

A Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Esophageal Squamous Cell Carcinoma

Primary Purpose

Esophageal Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Adjuvant radiotherapy
Adjuvant radiotherapy
Paclitaxel and carboplatin
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal cancer;adjuvant therapy;chemotherapy;radiotherapy

Eligibility Criteria

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

Inclusion Criteria:

  1. Histologically documented squamous cell carcinoma of the thoracic esophagus; undergoing radical esophagectomy; the pathological stage is T(primary tumor)1-4 N(regional lymph nodes)1-3 M(distant metastasis)0 (ESOPHAGUS, Union for International Cancer Control(UICC) 2010) ;
  2. Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy);
  3. The expectation of life is more than 6 months;
  4. Age: 18~70 years old;
  5. Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function);
  6. ECOG (Eastern Cooperative Oncology Group) : 0-1;
  7. Able to understand this study and have signed informed consent.

Exclusion Criteria:

  1. Have been treated with chemotherapy, radiotherapy and other anti tumor treatment except surgery;
  2. Known or suspected of allergy to paclitaxel or carboplatin;
  3. Female in pregnancy or lactating;
  4. With significant psychological, family, social and other factors which may affect the ability to understand and sign the informed consent;
  5. Patients with peripheral neuropathy(CTC grade≥2);
  6. With other malignant tumors before the recruitment.
  7. The researchers consider that the patient is not appropriate to enroll the study;
  8. The patient can't be tolerant to postoperative adjuvant radiotherapy and chemotherapy for serious heart/lung/liver/kidney function, the haematopoietic system diseases, the immune system diseases, the nervous system diseases, cachexia and so on.

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

adjuvant chemoradiotherapy

adjuvant radiotherapy

Arm Description

Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.

Adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.

Outcomes

Primary Outcome Measures

The overall survival
To evaluate the 3 years overall survival of two groups.

Secondary Outcome Measures

Disease-free survival
To evaluate the 3 years disease-free survival of two groups.
Adverse Events
Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE) 4.0
Scores of Quality of life
Assess the quality of life based on FACT-E

Full Information

First Posted
October 3, 2015
Last Updated
October 6, 2015
Sponsor
Zhejiang Cancer Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02570893
Brief Title
A Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Esophageal Squamous Cell Carcinoma
Official Title
A Multicenter, Randomized, Open-label, Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Patients Undergoing Radical Esophagectomy for Pathologic Lymph Node Positive Esophageal Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter, randomized, open-label, phase III trail comparing adjuvant chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell carcinoma.
Detailed Description
Patient Population: Age: 18-70y; Thoracic esophageal squamous cell cancer undergoing radical esophagectomy; Clinical stage T1-4, N1-3, M0; Eastern Cooperative Oncology Group (ECOG) score: 0-1; The patients are randomized to 2 arms. Arm A: Adjuvant radiotherapy (50.4gray/28fraction) followed by chemotherapy (Paclitaxel and carboplatin) 4 cycles. Arm B :Adjuvant radiotherapy (50.4gray/28fraction) only

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophageal cancer;adjuvant therapy;chemotherapy;radiotherapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
adjuvant chemoradiotherapy
Arm Type
Experimental
Arm Description
Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.
Arm Title
adjuvant radiotherapy
Arm Type
Experimental
Arm Description
Adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.
Intervention Type
Radiation
Intervention Name(s)
Adjuvant radiotherapy
Intervention Description
Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.
Intervention Type
Radiation
Intervention Name(s)
Adjuvant radiotherapy
Intervention Description
adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel and carboplatin
Primary Outcome Measure Information:
Title
The overall survival
Description
To evaluate the 3 years overall survival of two groups.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Disease-free survival
Description
To evaluate the 3 years disease-free survival of two groups.
Time Frame
3 years
Title
Adverse Events
Description
Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE) 4.0
Time Frame
1 year
Title
Scores of Quality of life
Description
Assess the quality of life based on FACT-E
Time Frame
1 year

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: Histologically documented squamous cell carcinoma of the thoracic esophagus; undergoing radical esophagectomy; the pathological stage is T(primary tumor)1-4 N(regional lymph nodes)1-3 M(distant metastasis)0 (ESOPHAGUS, Union for International Cancer Control(UICC) 2010) ; Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy); The expectation of life is more than 6 months; Age: 18~70 years old; Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function); ECOG (Eastern Cooperative Oncology Group) : 0-1; Able to understand this study and have signed informed consent. Exclusion Criteria: Have been treated with chemotherapy, radiotherapy and other anti tumor treatment except surgery; Known or suspected of allergy to paclitaxel or carboplatin; Female in pregnancy or lactating; With significant psychological, family, social and other factors which may affect the ability to understand and sign the informed consent; Patients with peripheral neuropathy(CTC grade≥2); With other malignant tumors before the recruitment. The researchers consider that the patient is not appropriate to enroll the study; The patient can't be tolerant to postoperative adjuvant radiotherapy and chemotherapy for serious heart/lung/liver/kidney function, the haematopoietic system diseases, the immune system diseases, the nervous system diseases, cachexia and so on.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weimin Mao, MD.
Phone
+86-571-88122032
Email
maowmzj1218@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yaping Xu, MD.
Phone
+86-571-88122082
Email
xuyaping1207@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weimin Mao, MD.
Organizational Affiliation
Zhejiang Cancer 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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimin Mao, MD.
Phone
+86-571-88122032
Email
maowmzj1218@163.com
First Name & Middle Initial & Last Name & Degree
Yaping Xu, MD.
Phone
+86-571-88122082
Email
xuyaping1207@gmail.com

12. IPD Sharing Statement

Learn more about this trial

A Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Esophageal Squamous Cell Carcinoma

We'll reach out to this number within 24 hrs