Esophageal CancerPhase 4COLNCT00911092
Predictive Proteomic Factors of the Response to Concomitant Radiochemotherapy in Esophageal Cancer
A Phase 4 study testing Blood sampling, Radiation and Chemotherapy (Fluorouracil and Cisplatin) in people with Esophageal Cancer, run by Centre Oscar Lambret at 6 sites in France.
Trial summary
The scope of the trial is to predict the early complete clinical response to exclusive concomitant radiochemotherapy in esophageal cancer by the study of the pre- and per- therapeutic proteomic profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Blood sampling, Radiation and Chemotherapy (Fluorouracil and Cisplatin)
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 6 sitesFrance
- Study dates
- Oct 2007to Dec 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasive esophageal carcinoma at any stage (all T, N0 or N1, M0 or M1a), histologically proven
- Treated by exclusive concomitant radiochemotherapy
- Written informed consent
Who cannot join
- Presence of a second uncontrolled cancer
- Metastatic carcinoma
- Metastatic disease, except cervical lymphnodes... (M1a)
- In situ carcinoma
- Eso-gastric junction cancer (Siewert II ou III)
- Inclusion in a clinical trial with an experimental drug during the study and until 15 weeks after the end of radiotherapy)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Paul Papin
Angers, 49933
Centre Hospitalier Universitaire
Brest, 29200
Centre François BACLESSE
Caen, 14046
Centre Oscar Lambret
Lille, 59020
Centre Eugène Marquis
Rennes, 35042
CHU - Hopital Charles Nicolle
Rouen, 76031
About this study
Official title: Study of Predictive Proteomic Factors of the Response to Exclusive Concomitant Radiochemotherapy in Oesophageal Cancer
The scope of the trial is to predict the early complete clinical response to exclusive concomitant radiochemotherapy in esophageal cancer by the study of the pre- and per- therapeutic proteomic profile.
Read the detailed description
Further informations will be provided by Centre Oscar Lambret.
- Conditions
- Esophageal Cancer
- Being tested
- Blood sampling, Radiation, Chemotherapy (Fluorouracil and Cisplatin)
- Keywords
- Oesophageal cancer, exclusive concomitant radiochemotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Before any study treatment, 14 days after radiotherapy, 15 weeks after radiotherapy
RadiationRadiation
Week 1 to week 5-6 1.8-2 Gys/fraction, 5 days a week for a total of 5 to 6 weeks
Chemotherapy (Fluorouracil and Cisplatin)Drug
At weeks 1, 5, 8 and 11
- Day 1 to day 4: Fluorouracil 1 gr/m²/day
- Day 1 or 2: Cisplatin 75 mg/m²
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomic analysis by Protein-Chip Technology of Ciphergen and mass spectrometry
Measured: 15 weeks after the end of irradiation
Initial complete clinical response
Measured: 15 weeks after the end of irradiation
Secondary outcomes (1)
Prolonged clinical response at one year
Measured: One year after the end of irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startOct 2007
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ADENIS Antoine, MD, PhD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911092
- Sponsor's protocol ID
- COL-0613
- Other IDs
- 2006-A00568-43
- Acronym
- COL
- Status last verified
- Sep 2026
- First submitted
- 29 May 2009
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Predictive Proteomic Factors of the Response to Exclusive Concomitant Radiochemotherapy in Oesophageal Cancer
- ClinicalTrials.gov ID
- NCT00911092
- Acronym / sponsor ID
- COL / COL-0613
- Conditions
- Esophageal Cancer
- Keywords
- Oesophageal cancer, exclusive concomitant radiochemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Jun 2009 (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.
The scope of the trial is to predict the early complete clinical response to exclusive concomitant radiochemotherapy in esophageal cancer by the study of the pre- and per- therapeutic proteomic profile.
Detailed description
Further informations will be provided by Centre Oscar Lambret.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Invasive esophageal carcinoma at any stage (all T, N0 or N1, M0 or M1a), histologically proven
- Treated by exclusive concomitant radiochemotherapy
- Written informed consent
Key exclusion criteria (6 listed)
- Presence of a second uncontrolled cancer
- Metastatic carcinoma
- Metastatic disease, except cervical lymphnodes... (M1a)
- In situ carcinoma
- Eso-gastric junction cancer (Siewert II ou III)
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 |
|---|---|---|
| Blood samplingBefore any study treatment, 14 days after radiotherapy, 15 weeks after radiotherapy | Procedure or surgery | – |
| RadiationWeek 1 to week 5-6 1.8-2 Gys/fraction, 5 days a week for a total of 5 to 6 weeks | Radiation | – |
| Chemotherapy (Fluorouracil and Cisplatin)At weeks 1, 5, 8 and 11 * Day 1 to day 4: Fluorouracil 1 gr/m²/day * Day 1 or 2: Cisplatin 75 mg/m² | Drug | – |
Primary outcome
Proteomic analysis by Protein-Chip Technology of Ciphergen and mass spectrometry
Time frame: 15 weeks after the end of irradiation
Initial complete clinical response
Time frame: 15 weeks after the end of irradiation
1 secondary outcome
Prolonged clinical response at one year
Time frame: One year after the end of irradiation
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 17 Sep 2026.
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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.
ADENIS Antoine, MD, PhD principal investigator
Centre Oscar Lambret
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood sampling, Radiation and Chemotherapy (Fluorouracil and Cisplatin) in people with Esophageal Cancer, run by Centre Oscar Lambret at 6 sites in France.
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 3 inclusion and 6 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proteomic analysis by Protein-Chip Technology of Ciphergen and mass spectrometry (time frame: 15 weeks after the end of irradiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.