Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Paclitaxel plus Cisplatin with radiotherapy
S1 plus Cisplatin with radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Pathologically proven squamous cell carcinoma of esophagus .
- Locally advanced esophageal cancer , with no operation indication
- M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer
- Subjects haven't been given neither radiotherapy nor chemotherapy before
- Age of 18-70
- PS ≦2
- Hemogram : WBC≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl
- With no difficulty in eating
- Expected lifetime ≧3 months
Exclusion Criteria:
- Invasion to surrounding organ ( T4 disease ) .
- Distant metastasis , except M1a disease .
- Complete obstruction of the esophagus, or patients who have the potential to develop perforation
- Women in status of pregnancy
Patients who have complications exist as following:
- Uncontrolled angina and heart failure, have a history of hospitalization in 3 months
- A history of myocardial infarction in the past 6 months
- There is a need for antibiotic treatment of acute bacterial or fungal infection
- Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization
- Drug addiction, alcoholism and AIDS disease or long-term virus carriers
- Uncontrollable seizures, or loss of insight because of mental illness
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Paclitaxel plus Cisplatin with radiotherapy
S1 plus Cisplatin with radiotherapy
Arm Description
patients will receive concurrent chemoradiotherapy with drug Paclitaxel plus Cisplatin
patients will receive concurrent chemoradiotherapy with drug S1 plus Cisplatin
Outcomes
Primary Outcome Measures
Overall survival (OS)
Secondary Outcome Measures
Progression-free survival (PFS)
Full Information
NCT ID
NCT02586753
First Posted
October 19, 2015
Last Updated
October 23, 2015
Sponsor
Mianyang Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02586753
Brief Title
Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
Official Title
A Phase II Study to Compare Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mianyang Central Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine which regimen is better for esophageal squamous carcinoma in concurrent chemoradiation(CCRT),paclitaxel or S1 plus cisplatin.
Detailed Description
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles or PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel plus Cisplatin with radiotherapy
Arm Type
Experimental
Arm Description
patients will receive concurrent chemoradiotherapy with drug Paclitaxel plus Cisplatin
Arm Title
S1 plus Cisplatin with radiotherapy
Arm Type
Experimental
Arm Description
patients will receive concurrent chemoradiotherapy with drug S1 plus Cisplatin
Intervention Type
Other
Intervention Name(s)
Paclitaxel plus Cisplatin with radiotherapy
Intervention Description
we want to compare which regime is better with radiotherapy, PT regime (paclitaxel and cisplatine ) Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.
Radiotherapy:Patients will be conducted CT simulation, and Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Intervention Type
Other
Intervention Name(s)
S1 plus Cisplatin with radiotherapy
Intervention Description
we want to compare which regime is better with radiotherapy,SP regime (Tegafur Gimeracil Oteracil Potassium Capsule and cisplatine).
Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.
Radiotherapy:Patients will be conducted CT simulation, and Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Primary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
five years after enrollment
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
five years after enrollment
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:
Pathologically proven squamous cell carcinoma of esophagus .
Locally advanced esophageal cancer , with no operation indication
M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer
Subjects haven't been given neither radiotherapy nor chemotherapy before
Age of 18-70
PS ≦2
Hemogram : WBC≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl
With no difficulty in eating
Expected lifetime ≧3 months
Exclusion Criteria:
Invasion to surrounding organ ( T4 disease ) .
Distant metastasis , except M1a disease .
Complete obstruction of the esophagus, or patients who have the potential to develop perforation
Women in status of pregnancy
Patients who have complications exist as following:
Uncontrolled angina and heart failure, have a history of hospitalization in 3 months
A history of myocardial infarction in the past 6 months
There is a need for antibiotic treatment of acute bacterial or fungal infection
Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization
Drug addiction, alcoholism and AIDS disease or long-term virus carriers
Uncontrollable seizures, or loss of insight because of mental illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Gao, Doctor
Phone
+8618681630773
Email
edna_9999@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bo X Du, Doctor
Phone
+8613550822229
Email
duxiaobo2005@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo X Du, Doctor
Organizational Affiliation
Mianyang Central Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20940718
Citation
Conroy T, Yataghene Y, Etienne PL, Michel P, Senellart H, Raoul JL, Mineur L, Rives M, Mirabel X, Lamezec B, Rio E, Le Prise E, Peiffert D, Adenis A. Phase II randomised trial of chemoradiotherapy with FOLFOX4 or cisplatin plus fluorouracil in oesophageal cancer. Br J Cancer. 2010 Oct 26;103(9):1349-55. doi: 10.1038/sj.bjc.6605943. Epub 2010 Oct 12.
Results Reference
background
Links:
URL
http://www.bjcancer.com
Description
Click here for more information about this study: Phase II randomised trial of chemoradiotherapy with FOLFOX4 or cisplatin plus fluorouracil in oesophageal cancer
Learn more about this trial
Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
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