Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
A Phase II Study to Compare Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
1 other identifier
interventional
2
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2015
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 26, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 26, 2015
October 1, 2015
9 months
October 19, 2015
October 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
five years after enrollment
Secondary Outcomes (1)
Progression-free survival (PFS)
five years after enrollment
Study Arms (2)
Paclitaxel plus Cisplatin with radiotherapy
EXPERIMENTALpatients will receive concurrent chemoradiotherapy with drug Paclitaxel plus Cisplatin
S1 plus Cisplatin with radiotherapy
EXPERIMENTALpatients will receive concurrent chemoradiotherapy with drug S1 plus Cisplatin
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 20940718BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bo X Du, Doctor
Mianyang Central Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 26, 2015
Study Start
December 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
October 26, 2015
Record last verified: 2015-10