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Moderately Hypofractionated Conformal Radiation Combined With S-1 for Esophageal Squamous Cell Carcinoma

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Moderately hypofractionated conformal radiation combined With S-1
Sponsored by
Sun Yat-sen 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, Hypofractionated Conformal Radiation, S-1

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed esophageal squamous cell carcinoma
  • Inoperable stage II-IVa (UICC 2002; sixth edition), confirmed by contrast enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography.
  • Eastern Cooperative Oncology Group (ECOG) performance status 1-2
  • Estimated life expectancy of at least 12 weeks
  • Charlson comorbidity index.4
  • Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1
  • Adequate renal function: creatinine grade 0 or 1
  • Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase <2 times of the upper normal limit
  • Weight loss.15% during 6 months prior to diagnosis
  • Forced expiratory volume second.1L

Exclusion Criteria:

  • Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ
  • Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy
  • Contraindication for chemotherapy or radiotherapy
  • Malignant pleural or pericardial effusion
  • Women in pregnancy or lactation period
  • Women who has the probability of pregnancy without contraception
  • Weight loss≥15% during 3 months prior to diagnosis
  • In other clinical trials within 30 days
  • Addicted in drugs or alcohol, AIDS patients
  • Uncontrollable seizure or psychotic patients without self-control ability
  • Severe allergy or idiosyncrasy
  • Not suitable for this study judged by researchers

Sites / Locations

  • Hui Liu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experiment

Arm Description

All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV.

Outcomes

Primary Outcome Measures

Progression-Free Survival

Secondary Outcome Measures

Overall Survival
rate of grade 3-4 radiation esophagitis
rate of grade 3-4 radiation pneumonitis

Full Information

First Posted
September 4, 2018
Last Updated
October 25, 2022
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03660449
Brief Title
Moderately Hypofractionated Conformal Radiation Combined With S-1 for Esophageal Squamous Cell Carcinoma
Official Title
A Prospective, Phase Ⅱ Study of S-1 Plus Moderately Hypofractionated Conformal Radiation for Esophageal Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen 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
This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma.
Detailed Description
This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma. All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date on which disease progresses. Progression-free survival will be calculated and compared using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.

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, Hypofractionated Conformal Radiation, S-1

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Experiment
Arm Type
Experimental
Arm Description
All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV.
Intervention Type
Combination Product
Intervention Name(s)
Moderately hypofractionated conformal radiation combined With S-1
Intervention Description
All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV.
Primary Outcome Measure Information:
Title
Progression-Free Survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
3 years
Title
rate of grade 3-4 radiation esophagitis
Time Frame
1 year
Title
rate of grade 3-4 radiation pneumonitis
Time Frame
1 year

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: Histologically confirmed esophageal squamous cell carcinoma Inoperable stage II-IVa (UICC 2002; sixth edition), confirmed by contrast enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography. Eastern Cooperative Oncology Group (ECOG) performance status 1-2 Estimated life expectancy of at least 12 weeks Charlson comorbidity index.4 Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1 Adequate renal function: creatinine grade 0 or 1 Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase <2 times of the upper normal limit Weight loss.15% during 6 months prior to diagnosis Forced expiratory volume second.1L Exclusion Criteria: Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy Contraindication for chemotherapy or radiotherapy Malignant pleural or pericardial effusion Women in pregnancy or lactation period Women who has the probability of pregnancy without contraception Weight loss≥15% during 3 months prior to diagnosis In other clinical trials within 30 days Addicted in drugs or alcohol, AIDS patients Uncontrollable seizure or psychotic patients without self-control ability Severe allergy or idiosyncrasy Not suitable for this study judged by researchers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Ph.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hui Liu
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Moderately Hypofractionated Conformal Radiation Combined With S-1 for Esophageal Squamous Cell Carcinoma

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