search
Back to results

Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)

Primary Purpose

Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Survival

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Paclitaxel plus carboplatin
radiotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring esophageal squamous cell carcinoma, elderly patients, chemoradiotherapy, definitive radiotherapy, survival

Eligibility Criteria

76 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Indicates no limit on eligibility based on the sex of participants
  • The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study.
  • Esophageal squamous cell carcinoma confirmed by pathology
  • No radiotherapy, chemotherapy or other treatments prior to enrollment
  • Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th)
  • Use of an effective contraceptive for adults to prevent pregnancy
  • No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function
  • No immunodeficiency
  • ECOG 0-1.
  • Life expectancy of more than 3 months.

Exclusion Criteria:

  • Total radiotherapy dose cannot reach 61.2Gy/34Fx
  • Esophageal perforation, or hematemesis
  • History of radiotherapy or chemotherapy for esophageal cancer
  • History of surgery within 28 days before Day 1
  • History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years)
  • Participation in other interventional clinical trials within 30 days
  • Pregnant or breast-feeding women or fertile patients
  • Drug addiction,
  • alcoholism or AIDS
  • Uncontrolled seizures or psychiatric disorders

Sites / Locations

  • Jiangsu Cancer HospitalRecruiting
  • Huadong HospitalRecruiting
  • Fudan Universtiy Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

chemoradiotherapy

radiotherapy

Arm Description

50.4Gy/28Fx; Paclitaxel plus carboplatin

61.2Gy/34Fx

Outcomes

Primary Outcome Measures

overall survival difference of definitive radiotherapy and chemoradiotherapy groups
The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.

Secondary Outcome Measures

difference of quality of life between different groups
Assess the quality of life through life quality questionnaire.
radiation side effects
Record the radiation side effects including acute and late side effects.
cancer specific survival
The time between the start of the study treatment (Day 1) and death from tumor or last follow-up for patients alive at the end of the study.

Full Information

First Posted
August 12, 2020
Last Updated
October 31, 2021
Sponsor
Fudan University
Collaborators
Huadong Hospital, Jiangsu Cancer Institute & Hospital, Gansu Cancer Hospital, The First Affiliated Hospital of Xiamen University, Fujian Cancer Hospital, Taihe Hospital, Wuxi No. 4 People's Hospital, Ningbo No.2 Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04519905
Brief Title
Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Official Title
Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fudan University
Collaborators
Huadong Hospital, Jiangsu Cancer Institute & Hospital, Gansu Cancer Hospital, The First Affiliated Hospital of Xiamen University, Fujian Cancer Hospital, Taihe Hospital, Wuxi No. 4 People's Hospital, Ningbo No.2 Hospital

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
So far, there is no specific clinical guideline for elderly patients (>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.
Detailed Description
Up to now, definitive radiotherapy was major treatment plan for elderly ESCC patients. However, whether elective elderly patients can obtain survival benefits through chemoradiotherapy is not clear. Thus we design the clinical trail to answer the question. Three hundred and twenty elderly patients with ESCC would be recruited. There are two stratification factors including 80 years old and lymph node metastasis. The patients in the chemoradiotherapy group were treated with paclitaxel (45mg/m2) and carboplatin (AUC=2) one cycle per week for five cycles.The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival. The life quality questionnaire included QlQ-C30 and OES-18.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Survival
Keywords
esophageal squamous cell carcinoma, elderly patients, chemoradiotherapy, definitive radiotherapy, survival

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
chemoradiotherapy
Arm Type
Experimental
Arm Description
50.4Gy/28Fx; Paclitaxel plus carboplatin
Arm Title
radiotherapy
Arm Type
Active Comparator
Arm Description
61.2Gy/34Fx
Intervention Type
Drug
Intervention Name(s)
Paclitaxel plus carboplatin
Intervention Description
Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
Different radiotherapy dose in different groups.
Primary Outcome Measure Information:
Title
overall survival difference of definitive radiotherapy and chemoradiotherapy groups
Description
The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.
Time Frame
3-year
Secondary Outcome Measure Information:
Title
difference of quality of life between different groups
Description
Assess the quality of life through life quality questionnaire.
Time Frame
the period of treatment within 7 weeks and follow up time with an average of 3months
Title
radiation side effects
Description
Record the radiation side effects including acute and late side effects.
Time Frame
acute side effects within 3 months, late side effects for 3 months later
Title
cancer specific survival
Description
The time between the start of the study treatment (Day 1) and death from tumor or last follow-up for patients alive at the end of the study.
Time Frame
3-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indicates no limit on eligibility based on the sex of participants The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study. Esophageal squamous cell carcinoma confirmed by pathology No radiotherapy, chemotherapy or other treatments prior to enrollment Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th) Use of an effective contraceptive for adults to prevent pregnancy No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function No immunodeficiency ECOG 0-1. Life expectancy of more than 3 months. Exclusion Criteria: Total radiotherapy dose cannot reach 61.2Gy/34Fx Esophageal perforation, or hematemesis History of radiotherapy or chemotherapy for esophageal cancer History of surgery within 28 days before Day 1 History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years) Participation in other interventional clinical trials within 30 days Pregnant or breast-feeding women or fertile patients Drug addiction, alcoholism or AIDS Uncontrolled seizures or psychiatric disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuaile Zhao, doctor
Phone
18017312534
Ext
021-64175590
Email
kuaile_z@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
ying jia Deng, doctor
Phone
18017312829
Email
dengjiaying3@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuaile Zhao, doctor
Organizational Affiliation
Fudan University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xiangpeng Zheng, doctor
Organizational Affiliation
Huadong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinjun C Ye, M.D.
Phone
13585175433
Ext
13585175433
Email
jjye2004@163.com
First Name & Middle Initial & Last Name & Degree
Jinjun C Ye, M.D.
Facility Name
Huadong Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangpeng Zheng, M.D.
Phone
8621-62483180
Ext
862162483180
Email
zhengxp@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiangpeng Zheng
Phone
862162483180
Ext
862162483180
Email
zhengxp@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiangpeng Zheng
Facility Name
Fudan Universtiy Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuaile Zhao, MD
Phone
18017312534
Email
kuaile_z@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)

We'll reach out to this number within 24 hrs