Radiochemotherapy in Elderly Patients With Oesophagus Cancer (Chronos)

Phase II of Radiochemotherapy in Elderly Patients With Oesophagus Cancer

Phase II study of radiochemotherapy for elderly patients with oesophagus cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • previous radiotherapy
  • no fit to treat

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm Cisplatin
Radiotherapy 50 Gy with cisplatin 75 mg/2 Day 1 and day 22 (2)
Arm cisplatin : 75mg/m2, day n*1 and day n*22, And radiotherapy 50 Gy, 2Gy/f
Other Names:
  • Arm Cisplatin
Experimental: Arm Oxaliplatin
Radiotherapy 50Gy Oxaliplatin 85mg/m2 every 2 weeks, (6)
85 mg/m2 every 2 weeks, 6 times And radiotherapy 50 Gy, 2Gy/f
Other Names:
  • Arm Oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of treatment: Number of patients with completed treatment
Time Frame: 6 weeks after end of the radiochemotherapy
number of patient with completed treatment
6 weeks after end of the radiochemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumoral response
Time Frame: 6 weeks after end of the radiochemotherapy
tumoral evaluation at 6 weeks after the treatment
6 weeks after end of the radiochemotherapy
Quality of life
Time Frame: 6 weeks after end of the radiochemotherapy
QLQC30
6 weeks after end of the radiochemotherapy
Quality of life
Time Frame: 6 weeks after end of the radiochemotherapy
ELD14
6 weeks after end of the radiochemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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