- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02879227
Radiochemotherapy in Elderly Patients With Oesophagus Cancer (Chronos)
August 22, 2016 updated by: Centre Hospitalier Universitaire de Besancon
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:
|
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:
|
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.
General Publications
- 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.
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P/2009/79
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.
Clinical Trials on Esophagus Cancer
-
Mayo ClinicFred Hutchinson Cancer CenterCompletedBarrett's Esophagus With High Grade Dsyplasia | Early Esophageal CancerUnited States
-
University of Alabama at BirminghamAventis Pharmaceuticals; Pharmacia and UpjohnCompletedEsophageal Cancer | Cancer of the Esophagus | Esophageal Neoplasm | Esophagus Cancer | Cancer of EsophagusUnited States
-
University Hospitals, LeicesterNational Institute for Health Research, United Kingdom; University of LeicesterCompletedBarretts Esophagus | Esophageal High-Grade Intraepithelial Neoplasia | Esophageal Cancer Stage IUnited Kingdom
-
University Medical Center GroningenCompletedEsophageal Cancer | Barrett Esophagus | Dysplasia in Barrett EsophagusNetherlands
-
Johns Hopkins UniversityAmerican Society for Gastrointestinal Endoscopy; Pentax Medical CorporationCompletedBarrett's Esophagus, Esophageal Intraepithelial NeoplasiaUnited States, Germany
-
Academisch Medisch Centrum - Universiteit van Amsterdam...University Medical Center Groningen; UMC Utrecht; Erasmus Medical Center; Catharina... and other collaboratorsNot yet recruitingEsophageal Cancer | Barrett Adenocarcinoma | Barretts Esophagus With Dysplasia
-
Mayo ClinicWithdrawnEsophageal Cancer | Cancer of the Esophagus | Esophagus Cancer | Cancer of Esophagus | Esophagus Neoplasm | Neoplasms, EsophagealUnited States
-
Pentax MedicalCompletedEsophageal Cancer | Barrett's EsophagusUnited States, Netherlands
-
University of Colorado, DenverUniversity of California, Los Angeles; H. Lee Moffitt Cancer Center and Research... and other collaboratorsRecruitingTREAT-BE Study (Treatment With Resection and Endoscopic Ablation Techniques for Barrett's Esophagus)Esophageal Cancer | Barrett's EsophagusUnited States
-
Capsulomics, Inc.Active, not recruitingEsophageal Cancer | Barrett EsophagusUnited States
Clinical Trials on Cisplatin
-
West China Second University HospitalRecruitingNeoadjuvant Chemotherapy | Epithelial Carcinoma, OvarianChina
-
Privo TechnologiesNational Cancer Institute (NCI)CompletedOral Squamous Cell CarcinomaUnited States
-
Insmed IncorporatedCompletedOsteosarcoma MetastaticUnited States
-
Cedars-Sinai Medical CenterRecruitingHPV Positive Oropharyngeal Squamous Cell CarcinomaUnited States
-
Korea Cancer Center HospitalCompletedCervical CancersKorea, Republic of
-
Samsung Medical CenterUnknownNasophayngeal Carcinoma Between Stage II and IVbKorea, Republic of
-
Sun Yat-sen UniversityActive, not recruitingNasopharyngeal CarcinomaChina
-
Lawson Health Research InstituteRecruitingLocally Advanced Head and Neck Squamous Cell CarcinomaCanada
-
Taiho Oncology, Inc.Quintiles, Inc.Completed
-
Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University; Guangdong Provincial People... and other collaboratorsActive, not recruitingNasopharyngeal Carcinoma | Nasopharyngeal Neoplasms | Nasopharyngeal Diseases | Head and Neck NeoplasmChina