Back to resultsS-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer
Primary Purpose
Esophageal Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
S-1, Nedaplatin
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal Cancer, radiation, s-1, nedaplatin
Eligibility Criteria
Inclusion Criteria:
- Histologic proof of primary squamous cell or adenocarcinoma of the esophagus
- Locoregionally advanced carcinoma of esophagus without systemic metastases
- Zubrod Performance Status 0-1;
- Patients ≥ 18 years of age;
- No hypersensitivity to E. coli -derived products;
- AGC ≥ 1500/mm3, platelets ≥ 150,000/mm3, Hgb ≥ 10 gm%, serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 65 cc/min; serum calcium ≤ 11gm/dl;
- Patients with prior malignancy are eligible if curable non-melanoma skin cancer or cervical cancer in situ or disease free ≥ 5 years;
- No prior chest or upper abdomen radiotherapy; no prior systemic chemotherapy within the past 5 years; no prior esophageal or gastric surgery;
- Written informed consent.
Exclusion Criteria:
- Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- Prior systemic chemotherapy or radiation therapy for esophageal cancer
Sites / Locations
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chemoradiotherapy
Arm Description
Thoracic radiation 60Gy over 30 fractions.Concurrently, nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 was given on Days 1-14,repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.
Outcomes
Primary Outcome Measures
Maximum tolerated dose (MTD) of s-1 in combination with nedaplatin and thoracic radiotherapy
the MTD will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) during treatment.
Secondary Outcome Measures
Objective response rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01175460
Brief Title
S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer
Official Title
Phase I Study of S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with advanced esophageal cancer will receive thoracic radiation therapy 60Gy over 30 fractions,and concurrent with s-1 and nedaplatin.
Detailed Description
Purpose: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 in combination with nedaplatin and thoracic radiotherapy in patients with advanced esophageal Cancer.
Methods: Thoracic radiation therapy was administered in 2Gy fractions five times weekly to a total dose of 60 Gy.Concurrently, nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 was given on Days 1-14,repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
esophageal Cancer, radiation, s-1, nedaplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemoradiotherapy
Arm Type
Experimental
Arm Description
Thoracic radiation 60Gy over 30 fractions.Concurrently, nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 was given on Days 1-14,repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.
Intervention Type
Drug
Intervention Name(s)
S-1, Nedaplatin
Intervention Description
nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 on Days 1-14, repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD) of s-1 in combination with nedaplatin and thoracic radiotherapy
Description
the MTD will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) during treatment.
Time Frame
3 months per patient
Secondary Outcome Measure Information:
Title
Objective response rate
Time Frame
dependent upon results
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:
Histologic proof of primary squamous cell or adenocarcinoma of the esophagus
Locoregionally advanced carcinoma of esophagus without systemic metastases
Zubrod Performance Status 0-1;
Patients ≥ 18 years of age;
No hypersensitivity to E. coli -derived products;
AGC ≥ 1500/mm3, platelets ≥ 150,000/mm3, Hgb ≥ 10 gm%, serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 65 cc/min; serum calcium ≤ 11gm/dl;
Patients with prior malignancy are eligible if curable non-melanoma skin cancer or cervical cancer in situ or disease free ≥ 5 years;
No prior chest or upper abdomen radiotherapy; no prior systemic chemotherapy within the past 5 years; no prior esophageal or gastric surgery;
Written informed consent.
Exclusion Criteria:
Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
Prior systemic chemotherapy or radiation therapy for esophageal cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xianghui Du, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
12. IPD Sharing Statement
Learn more about this trial
S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer
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