Esophagus CancerPhase 2ChronosNCT02879227
Radiochemotherapy in Elderly Patients With Oesophagus Cancer
A Phase 2 study testing Cisplatin and Oxaliplatin in people with Esophagus Cancer, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
Phase II study of radiochemotherapy for elderly patients with oesophagus cancer. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- Cisplatin and Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients aged 75 or more with oesophagus cancer (squamous or adenocarcinoma), fit to treat
Who cannot join
- previous radiotherapy
- no fit to treat
About this study
Official title: Phase II of Radiochemotherapy in Elderly Patients With Oesophagus Cancer
Phase II study of radiochemotherapy for elderly patients with oesophagus cancer.
Read the 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.
- Conditions
- Esophagus Cancer
- Being tested
- Cisplatin, Oxaliplatin
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Arm Cisplatin
Arm cisplatin : 75mg/m2, day n*1 and day n*22, And radiotherapy 50 Gy, 2Gy/f
OxaliplatinDrug
Also called Arm Oxaliplatin
85 mg/m2 every 2 weeks, 6 times And radiotherapy 50 Gy, 2Gy/f
| Study group | Role | What they receive |
|---|---|---|
| Arm Cisplatin | Active comparator | Radiotherapy 50 Gy with cisplatin 75 mg/2 Day 1 and day 22 (2) Receives: Drug: Cisplatin |
| Arm Oxaliplatin | Experimental | Radiotherapy 50Gy Oxaliplatin 85mg/m2 every 2 weeks, (6) Receives: Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of treatment: Number of patients with completed treatment
number of patient with completed treatment
Measured: 6 weeks after end of the radiochemotherapy
Secondary outcomes (3)
Tumoral response
tumoral evaluation at 6 weeks after the treatment
Measured: 6 weeks after end of the radiochemotherapy
Quality of life
QLQC30
Measured: 6 weeks after end of the radiochemotherapy
Quality of life
ELD14
Measured: 6 weeks after end of the radiochemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startJan 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879227
- Sponsor's protocol ID
- P/2009/79
- Acronym
- Chronos
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
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.
PubMed 19358620Servagi-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.
PubMed 26038198
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II of Radiochemotherapy in Elderly Patients With Oesophagus Cancer
- ClinicalTrials.gov ID
- NCT02879227
- Acronym / sponsor ID
- Chronos / P/2009/79
- Conditions
- Esophagus Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Cisplatin | Active comparator | Drug: CisplatinRadiotherapy 50 Gy with cisplatin 75 mg/2 Day 1 and day 22 (2) |
| Arm Oxaliplatin | Experimental | Drug: OxaliplatinRadiotherapy 50Gy Oxaliplatin 85mg/m2 every 2 weeks, (6) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- patients aged 75 or more with oesophagus cancer (squamous or adenocarcinoma), fit to treat
Key exclusion criteria (2 listed)
- previous radiotherapy
- no fit to treat
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinAlso: Arm CisplatinArm cisplatin : 75mg/m2, day n*1 and day n*22, And radiotherapy 50 Gy, 2Gy/f | Drug | Arm Cisplatin |
| OxaliplatinAlso: Arm Oxaliplatin85 mg/m2 every 2 weeks, 6 times And radiotherapy 50 Gy, 2Gy/f | Drug | Arm Oxaliplatin |
Primary outcome
Feasibility of treatment: Number of patients with completed treatment
Time frame: 6 weeks after end of the radiochemotherapy
number of patient with completed treatment
3 secondary outcomes
Tumoral response
Time frame: 6 weeks after end of the radiochemotherapy
Quality of life
Time frame: 6 weeks after end of the radiochemotherapy
Quality of life
Time frame: 6 weeks after end of the radiochemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Background: PubMed 19358620Servagi-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.
- Results publication: PubMed 26038198Servagi-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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin and Oxaliplatin in people with Esophagus Cancer, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of treatment: Number of patients with completed treatment (time frame: 6 weeks after end of the radiochemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02879227, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.