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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
Mianyang Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pathologically proven squamous cell carcinoma of esophagus .
  2. Locally advanced esophageal cancer , with no operation indication
  3. M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer
  4. Subjects haven't been given neither radiotherapy nor chemotherapy before
  5. Age of 18-70
  6. PS ≦2
  7. 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
  8. With no difficulty in eating
  9. Expected lifetime ≧3 months

Exclusion Criteria:

  1. Invasion to surrounding organ ( T4 disease ) .
  2. Distant metastasis , except M1a disease .
  3. Complete obstruction of the esophagus, or patients who have the potential to develop perforation
  4. Women in status of pregnancy

  5. 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

    First Posted
    October 19, 2015
    Last Updated
    October 23, 2015
    Sponsor
    Mianyang Central Hospital
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    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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