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Clinical Trials/NCT02879227
NCT02879227
Completed
Phase 2

Phase II of Radiochemotherapy in Elderly Patients With Oesophagus Cancer

Centre Hospitalier Universitaire de Besancon0 sites23 target enrollmentJanuary 2010

Overview

Phase
Phase 2
Intervention
Cisplatin
Conditions
Esophagus Cancer
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrollment
23
Primary Endpoint
Feasibility of treatment: Number of patients with completed treatment
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
December 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Arm Cisplatin

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

Intervention: Cisplatin

Arm Oxaliplatin

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

Intervention: Oxaliplatin

Outcomes

Primary Outcomes

Feasibility of treatment: Number of patients with completed treatment

Time Frame: 6 weeks after end of the radiochemotherapy

number of patient with completed treatment

Secondary Outcomes

  • Tumoral response(6 weeks after end of the radiochemotherapy)
  • Quality of life(6 weeks after end of the radiochemotherapy)

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