Back to resultsS-1 and Radiotherapy for Elderly Esophageal Cancer Patients
Primary Purpose
Esophageal Cancer, S-1, Radiotherapy
Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S-1
radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal cancer, Radiotherapy, elder, S-1
Eligibility Criteria
Inclusion Criteria:
- Cytologically or histologically confirmed esophageal carcinoma;
- ECOG performance status: 0-1;
- No treatments prior to enrollment;
- At least one measurable lesion on CT, MRI or esophageal barium exam;
- Normal functions of heart, lung, liver, kidney and bone marrow;
- Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL;
- Informed consent signed.
Exclusion Criteria:
- Prior treatments of chemotherapy or irradiation;
- Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
- Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
- Participating in other clinical trials;
- Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
- The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
Sites / Locations
- Zhejiang Provincial People's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiotherapy and S-1 arm
Arm Description
Radiotherapy will be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy. Preplanned concurrent S-1 (70mg/m²/day) will be administered on Day 1 for 14 days, every 3 weeks. After dCRT, maintenance S-1 will be given up to two cycles.
Outcomes
Primary Outcome Measures
response rate
Response rate will be done after 4 weeks following the last radiotherapy session.
Secondary Outcome Measures
Progression-free survival
Progression-free survival (PFS) will be calculated from the date of CCRT initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining.
Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)
Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).
Overall survival
Overall survival (OS) wiil be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.
Full Information
NCT ID
NCT02716688
First Posted
February 11, 2016
Last Updated
September 20, 2023
Sponsor
Zhejiang Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02716688
Brief Title
S-1 and Radiotherapy for Elderly Esophageal Cancer Patients
Official Title
A Phase Ⅱ Study of S-1 With Concurrent Radiotherapy in Elderly Esophageal Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No patients enrolled.
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Provincial People's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the efficacy and toxicity of S-1 with concurrent radiotherapy in older patients with esophageal cancer.
Detailed Description
Older patients with esophageal cancer have been correlated with poor prognosis because of having little chance to receive aggressive local therapy, including concurrent chemoradiotherapy. In this phase II trial, the efficacy and toxicity of S-1 with concurrent radiotherapy will be investigated in this setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, S-1, Radiotherapy
Keywords
Esophageal cancer, Radiotherapy, elder, 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
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy and S-1 arm
Arm Type
Experimental
Arm Description
Radiotherapy will be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy. Preplanned concurrent S-1 (70mg/m²/day) will be administered on Day 1 for 14 days, every 3 weeks. After dCRT, maintenance S-1 will be given up to two cycles.
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
S-1 will be administered orally twice daily for 14 days at a dose of 70 mg/m2/day with concurrent radiotherapy for 2 cycles. Patients who showed a response greater than that of stable disease underwent additional S-1 until disease progression, serious adverse events, or patient refusal up to four cycles.
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Other Intervention Name(s)
Irradiation
Intervention Description
Radiotherapy wiil be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy.
Primary Outcome Measure Information:
Title
response rate
Description
Response rate will be done after 4 weeks following the last radiotherapy session.
Time Frame
week 4
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Progression-free survival (PFS) will be calculated from the date of CCRT initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining.
Time Frame
year 0 - year 2
Title
Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)
Description
Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).
Time Frame
year 0 - year 1
Title
Overall survival
Description
Overall survival (OS) wiil be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.
Time Frame
year 0 - year 2
Other Pre-specified Outcome Measures:
Title
Dysphagia score
Description
Dysphagia score was measured according to the following scale: 0, able to consume a normal diet; 1, able to swallow certain solid foods; 2, able to swallow only semisolid foods; 3, able to swallow liquids only; and 4, unable to swallow anything.
Time Frame
month 0 - month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cytologically or histologically confirmed esophageal carcinoma;
ECOG performance status: 0-1;
No treatments prior to enrollment;
At least one measurable lesion on CT, MRI or esophageal barium exam;
Normal functions of heart, lung, liver, kidney and bone marrow;
Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL;
Informed consent signed.
Exclusion Criteria:
Prior treatments of chemotherapy or irradiation;
Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
Participating in other clinical trials;
Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
Facility Information:
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
12. IPD Sharing Statement
Learn more about this trial
S-1 and Radiotherapy for Elderly Esophageal Cancer Patients
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