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Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

radiation

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Esophageal squamous cell carcinoma, postoperative radiotherapy

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≥3x109/L, Neutrophils (ANC )≥1.5x109/L • platelet count (Pt) ≥100x 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

Shanghai Cancer Center
Cancer hospital Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation group

Arm Description

Radiation therapy

Outcomes

Primary Outcome Measures

Local control rate

Secondary Outcome Measures

Overall survival

Safety: Frequencies of treatment-related adverse event categories by NCI-CTC

Frequencies of treatment-related adverse event categories by NCI-CTC including Esophagitis,Pneumonitis/Bronchitis,Skin reaction in radiation fields,Nausea/vomiting,Leucopenia,Thrombocytopenia,Anemia,Fatigue.

Full Information

NCT ID

NCT02384811

First Posted

March 2, 2015

Last Updated

September 4, 2017

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT02384811

Brief Title

Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma

Official Title

Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2014 (Actual)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma.

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, postoperative radiotherapy

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

Radiation group

Arm Type

Experimental

Arm Description

Radiation therapy

Intervention Type

Radiation

Intervention Name(s)

radiation

Intervention Description

A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks. The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes.

Primary Outcome Measure Information:

Title

Local control rate

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

5 year

Title

Safety: Frequencies of treatment-related adverse event categories by NCI-CTC

Description

Time Frame

3 months

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: 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≥3x109/L, Neutrophils (ANC )≥1.5x109/L • platelet count (Pt) ≥100x 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

Jia-qing Xiang, M.M

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200000

Country

China

Facility Name

Cancer hospital Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

34295813

Citation

Zhang X, Ai D, Wang J, Chen Y, Liu Q, Deng J, Yang H, Nie Y, Chen W, Zhao W, Zhao K. The Prognosis and Feasibility of Extensive Clinical Target Volume in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma: A Phase II Clinical Trial. Front Oncol. 2021 Jul 2;11:669575. doi: 10.3389/fonc.2021.669575. eCollection 2021.

Results Reference

derived

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Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma

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