Radiochemotherapy in Elderly Patients With Oesophagus Cancer

NCT ID: NCT02879227

Last Updated: 2016-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Esophagus Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm Cisplatin

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

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

Arm cisplatin : 75mg/m2, day n\*1 and day n\*22, And radiotherapy 50 Gy, 2Gy/f

Arm Oxaliplatin

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

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

85 mg/m2 every 2 weeks, 6 times And radiotherapy 50 Gy, 2Gy/f

Interventions

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Cisplatin

Arm cisplatin : 75mg/m2, day n\*1 and day n\*22, And radiotherapy 50 Gy, 2Gy/f

Intervention Type DRUG

Oxaliplatin

85 mg/m2 every 2 weeks, 6 times And radiotherapy 50 Gy, 2Gy/f

Intervention Type DRUG

Other Intervention Names

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Arm Cisplatin Arm Oxaliplatin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* previous radiotherapy
* no fit to treat
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type BACKGROUND
PMID: 19358620 (View on PubMed)

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.

Reference Type RESULT
PMID: 26038198 (View on PubMed)

Other Identifiers

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P/2009/79

Identifier Type: -

Identifier Source: org_study_id

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