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Radiochemotherapy in Elderly Patients With Oesophagus Cancer (Chronos)

Primary Purpose

Esophagus Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cisplatin
Oxaliplatin
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagus Cancer

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients aged 75 or more with oesophagus cancer (squamous or adenocarcinoma), fit to treat

Exclusion Criteria:

  • previous radiotherapy
  • no fit to treat

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Arm Cisplatin

    Arm Oxaliplatin

    Arm Description

    Radiotherapy 50 Gy with cisplatin 75 mg/2 Day 1 and day 22 (2)

    Radiotherapy 50Gy Oxaliplatin 85mg/m2 every 2 weeks, (6)

    Outcomes

    Primary Outcome Measures

    Feasibility of treatment: Number of patients with completed treatment
    number of patient with completed treatment

    Secondary Outcome Measures

    Tumoral response
    tumoral evaluation at 6 weeks after the treatment
    Quality of life
    QLQC30
    Quality of life
    ELD14

    Full Information

    First Posted
    August 3, 2016
    Last Updated
    August 22, 2016
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02879227
    Brief Title
    Radiochemotherapy in Elderly Patients With Oesophagus Cancer
    Acronym
    Chronos
    Official Title
    Phase II of Radiochemotherapy in Elderly Patients With Oesophagus Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Phase II study of radiochemotherapy for elderly patients with oesophagus cancer.
    Detailed Description
    Phase II study of radiochemotherapy for elderly patients with oesophagus cancer with Radiotherapy = 50 Gy, 2Gy/f ans chemotherapy with 2 arms arm Cisplatin = Cisplatin 75mg/m2 J1J22 or arm Oxaliplatine = oxaliplatine 85mg/m2 every 2 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophagus Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm Cisplatin
    Arm Type
    Active Comparator
    Arm Description
    Radiotherapy 50 Gy with cisplatin 75 mg/2 Day 1 and day 22 (2)
    Arm Title
    Arm Oxaliplatin
    Arm Type
    Experimental
    Arm Description
    Radiotherapy 50Gy Oxaliplatin 85mg/m2 every 2 weeks, (6)
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Other Intervention Name(s)
    Arm Cisplatin
    Intervention Description
    Arm cisplatin : 75mg/m2, day n*1 and day n*22, And radiotherapy 50 Gy, 2Gy/f
    Intervention Type
    Drug
    Intervention Name(s)
    Oxaliplatin
    Other Intervention Name(s)
    Arm Oxaliplatin
    Intervention Description
    85 mg/m2 every 2 weeks, 6 times And radiotherapy 50 Gy, 2Gy/f
    Primary Outcome Measure Information:
    Title
    Feasibility of treatment: Number of patients with completed treatment
    Description
    number of patient with completed treatment
    Time Frame
    6 weeks after end of the radiochemotherapy
    Secondary Outcome Measure Information:
    Title
    Tumoral response
    Description
    tumoral evaluation at 6 weeks after the treatment
    Time Frame
    6 weeks after end of the radiochemotherapy
    Title
    Quality of life
    Description
    QLQC30
    Time Frame
    6 weeks after end of the radiochemotherapy
    Title
    Quality of life
    Description
    ELD14
    Time Frame
    6 weeks after end of the radiochemotherapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients aged 75 or more with oesophagus cancer (squamous or adenocarcinoma), fit to treat Exclusion Criteria: previous radiotherapy no fit to treat

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    19358620
    Citation
    Servagi-Vernat S, Bosset M, Crehange G, Buffet-Miny J, Puyraveau M, Maingon P, Mercier M, Bosset JF. Feasibility of chemoradiotherapy for oesophageal cancer in elderly patients aged >or=75 years: a prospective, single-arm phase II study. Drugs Aging. 2009;26(3):255-62. doi: 10.2165/00002512-200926030-00006.
    Results Reference
    background
    PubMed Identifier
    26038198
    Citation
    Servagi-Vernat S, Crehange G, Roullet B, Guimas V, Maingon P, Puyraveau M, Bosset JF. Phase II Study of a Platinum-Based Adapted Chemotherapy Regimen Combined with Radiotherapy in Patients 75 Years and Older with Esophageal Cancer. Drugs Aging. 2015 Jun;32(6):487-93. doi: 10.1007/s40266-015-0275-8.
    Results Reference
    result

    Learn more about this trial

    Radiochemotherapy in Elderly Patients With Oesophagus Cancer

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