NCT02879227

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

4.9 years

First QC Date

August 3, 2016

Last Update Submit

August 22, 2016

Conditions

Esophagus Cancer

Outcome Measures

Primary Outcomes (1)

  • Feasibility of treatment: Number of patients with completed treatment

    number of patient with completed treatment

    6 weeks after end of the radiochemotherapy

Secondary Outcomes (3)

  • Tumoral response

    6 weeks after end of the radiochemotherapy

  • Quality of life

    6 weeks after end of the radiochemotherapy

  • Quality of life

    6 weeks after end of the radiochemotherapy

Study Arms (2)

Arm Cisplatin

ACTIVE COMPARATOR

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

Drug: Cisplatin

Arm Oxaliplatin

EXPERIMENTAL

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

Drug: Oxaliplatin

Interventions

CisplatinDRUG

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

Also known as: Arm Cisplatin
Arm Cisplatin
OxaliplatinDRUG

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

Also known as: Arm Oxaliplatin
Arm Oxaliplatin

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • previous radiotherapy
  • no fit to treat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 19358620BACKGROUND

  • 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.

    PMID: 26038198RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

CisplatinOxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCoordination ComplexesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 25, 2016

Study Start

January 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 25, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share