Radiochemotherapy in Elderly Patients With Oesophagus Cancer

Phase 2

Completed

• Conditions: Esophagus Cancer
• Interventions: Drug: Cisplatin; Drug: Oxaliplatin

• Registration Number: NCT02879227
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-08
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-22
• Last Update Submitted: 2016-08-22
• Study First Posted: 2016-08-25
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

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

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Exclusion Criteria

• previous radiotherapy
• no fit to treat

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm Cisplatin	Cisplatin	Radiotherapy 50 Gy with cisplatin 75 mg/2 Day 1 and day 22 (2)
Arm Oxaliplatin	Oxaliplatin	Radiotherapy 50Gy Oxaliplatin 85mg/m2 every 2 weeks, (6)

Primary Outcome Measures

Name	Time	Method
Feasibility of treatment: Number of patients with completed treatment	6 weeks after end of the radiochemotherapy	number of patient with completed treatment

Secondary Outcome Measures

Name	Time	Method
Tumoral response	6 weeks after end of the radiochemotherapy	tumoral evaluation at 6 weeks after the treatment
Quality of life	6 weeks after end of the radiochemotherapy	ELD14