Epidermoid Carcinoma orPhase 2/3EsostrateNCT02551458
Comparison of Systematic Surgery Versus Surveillance and Rescue Surgery in Operable Oesophageal Cancer With a Complete Clinical Response to Radiochemotherapy
A Phase 2/3 study testing Systematic surgery and Surveillance and rescue surgery in cases of resectable loco-regional recurrence in people with Epidermoid Carcinoma or and Adenocarcinoma of the Thoracic Oesophagus or, run by Centre Hospitalier Universitaire Dijon at 18 sites in France.
Trial summary
Step 1: Inclusion of eligible patients to carry out a translational search for prognostic and predictive markers of Complete Clinical Response and Pathologic Complete Response (using blood samples and diagnostic biopsies) and to collect data on radiochemotherapy and its toxicity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epidermoid Carcinoma or, Adenocarcinoma of the Thoracic Oesophagus or, Adenocarcinoma of the Oesogastric Junction (Siewert Type I or II)
- What is being tested?
- Systematic surgery and Surveillance and rescue surgery in cases of resectable loco-regional recurrence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 18 sitesFrance
- Study dates
- 14 Mar 2016to 15 Mar 2023
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Epidermoid carcinoma (EC) or adenocarcinoma of the thoracic oesophagus or adenocarcinoma of the oesogastric junction (Siewert type I or II) proven histologically
- Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0 after a full investigation
- Patient considered operable with a curative intent and scheduled to undergo first-line radiochemotherapy in a multidisciplinary meeting
- Age ≥ 18 years < 75 years
- Patient with national health insurance cover and who has provided written informed consent for the clinical and biological studies.
Who cannot join
- Cancer of the cervical oesophagus (15 to 19 cm from the dental arches)
- Weight loss > 15% at the recruitment with no improvement after nutritional support
- Serious comorbidity threatening survival in the short term
- Contra-indication for radiochemotherapy
- Other uncured malignant disease in the 5 previous years (except for in situ cervical carcinoma and treated non-melanotic skin cancers)
- Absence of effective contraception in patients (men or women) able to procreate, pregnant or breast-feeding women
- Impossibility to follow the trial
- Legal disqualification (patients in custody or under guardianship)
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
CHU Amiens
Amiens, 80054
Centre d'oncologie et de radiothérapie du Pays Basque
Bayonne, 64100
CH de la Côte Basque
Bayonne, 64109
Boulogne Sur Mer
Boulogne-sur-Mer, 62200
Infirmerie protestante de Lyon
Caluire-et-Cuire, 69300
Hôpitaux civils de Colmar
Colmar, 68024
CHU de DIJON
Dijon, 21079
Hôpital Michallon (GRENOBLE)
La Tronche, 38700
Centre Oscar Lambret
Lille, 59000
Hôpital Claude Huriez
Lille, 59000
Clinique Chenieux
Limoges, 87039
CHU de Limoges
Limoges, 87042
CH Saint Joseph Saint Luc
Lyon, 69007
Hôpital privé Jean Mermoz
Lyon, 69008
Institut Mutualiste MONTSOURIS
Paris, 75014
Centre Hospitalier Annecy Genevois
Pringy, 74374
CHP Saint Grégoire
Saint-Grégoire, 35760
Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY
Step 1: Inclusion of eligible patients to carry out a translational search for prognostic and predictive markers of Complete Clinical Response and Pathologic Complete Response (using blood samples and diagnostic biopsies) and to collect data on radiochemotherapy and its toxicity.
The trial will evaluate strategies after neoadjuvant treatment and not RCT protocols. The RCT will thus be chosen by the investigator from published effective schemes in a pre-operative setting or in patients not undergoing surgery.
Read more
Evaluation of the response 5 to 6 weeks after the RCT.
Step 2: Randomisation in patients with a complete clinical response:
Arm A: Systematic surgery Arm B: Surveillance and rescue surgery in cases with resectable loco-regional recurrence
Patients not eligible for randomisation will have the possibility to participate in a specific study (information can be obtained from the SAKK group (Switzerland Group Clinical Research on Cancer)).
- Conditions
- Epidermoid Carcinoma or, Adenocarcinoma of the Thoracic Oesophagus or, Adenocarcinoma of the Oesogastric Junction (Siewert Type I or II), Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0
- Being tested
- Systematic surgery, Surveillance and rescue surgery in cases of resectable loco-regional recurrence
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic surgeryOther
Surveillance and rescue surgery in cases of resectable loco-regional recurrenceOther
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Systematic surgery | Experimental | Not described Receives: Other: Systematic surgery |
| Arm B: Surveillance and rescue surgery in cases of resectable | Experimental | Not described Receives: Other: Surveillance and rescue surgery in cases of resectable loco-regional recurrence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of surviving patients
Measured: 1 year after randomisation
Disease-free survival
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start14 Mar 2016
- Primary completion15 Mar 2023
Why it stopped: sub-optimal inclusion rate, additional 9 years to finalize inclusion and follow-up of all patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermoid Carcinoma orStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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 2/3
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551458
- Sponsor's protocol ID
- Bedenne PHRC N 2013
- Acronym
- Esostrate
- Status last verified
- Mar 2024
- First submitted
- 20 Aug 2015
- Last updated
- 7 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY
- ClinicalTrials.gov ID
- NCT02551458
- Acronym / sponsor ID
- Esostrate / Bedenne PHRC N 2013
- Conditions
- Epidermoid Carcinoma or, Adenocarcinoma of the Thoracic Oesophagus or, Adenocarcinoma of the Oesogastric Junction (Siewert Type I or II), Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sub-optimal inclusion rate, additional 9 years to finalize inclusion and follow-up of all patients.
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 14 Mar 2016 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- First posted
- 16 Sep 2015 (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.
Step 1: Inclusion of eligible patients to carry out a translational search for prognostic and predictive markers of Complete Clinical Response and Pathologic Complete Response (using blood samples and diagnostic biopsies) and to collect data on radiochemotherapy and its toxicity.
The trial will evaluate strategies after neoadjuvant treatment and not RCT protocols. The RCT will thus be chosen by the investigator from published effective schemes in a pre-operative setting or in patients not undergoing surgery.
Evaluation of the response 5 to 6 weeks after the RCT.
Step 2: Randomisation in patients with a complete clinical response:
Arm A: Systematic surgery Arm B: Surveillance and rescue surgery in cases with resectable loco-regional recurrence
Patients not eligible for randomisation will have the possibility to participate in a specific study (information can be obtained from the SAKK group (Switzerland Group Clinical Research on Cancer)).
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Systematic surgery | Experimental | Other: Systematic surgery |
| Arm B: Surveillance and rescue surgery in cases of resectable | Experimental | Other: Surveillance and rescue surgery in cases of resectable loco-regional recurrence |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Epidermoid carcinoma (EC) or adenocarcinoma of the thoracic oesophagus or adenocarcinoma of the oesogastric junction (Siewert type I or II) proven histologically
- Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0 after a full investigation
- Patient considered operable with a curative intent and scheduled to undergo first-line radiochemotherapy in a multidisciplinary meeting
- Age ≥ 18 years < 75 years
- Patient with national health insurance cover and who has provided written informed consent for the clinical and biological studies.
Key exclusion criteria (8 listed)
- Cancer of the cervical oesophagus (15 to 19 cm from the dental arches)
- Weight loss > 15% at the recruitment with no improvement after nutritional support
- Serious comorbidity threatening survival in the short term
- Contra-indication for radiochemotherapy
- Other uncured malignant disease in the 5 previous years (except for in situ cervical carcinoma and treated non-melanotic skin cancers)
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 |
|---|---|---|
| Systematic surgery | Other | Arm A: Systematic surgery |
| Surveillance and rescue surgery in cases of resectable loco-regional recurrence | Other | Arm B: Surveillance and rescue surgery in cases of resectable |
Primary outcome
Proportion of surviving patients
Time frame: 1 year after randomisation
Disease-free survival
Time frame: Up to 5 years
Results and safety
The study was stopped early (reason given: sub-optimal inclusion rate, additional 9 years to finalize inclusion and follow-up of all patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Systematic surgery and Surveillance and rescue surgery in cases of resectable loco-regional recurrence in people with Epidermoid Carcinoma or and Adenocarcinoma of the Thoracic Oesophagus or, run by Centre Hospitalier Universitaire Dijon at 18 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: sub-optimal inclusion rate, additional 9 years to finalize inclusion and follow-up of all patients.). Results are not available in the source record.
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?
Proportion of surviving patients (time frame: 1 year after randomisation). 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 7 Mar 2024.