Comparison of Systematic Surgery Versus Surveillance and Rescue Surgery in Operable Oesophageal Cancer With a Complete Clinical Response to Radiochemotherapy
NCT ID: NCT02551458
Last Updated: 2024-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
188 participants
INTERVENTIONAL
2016-03-14
Brief Summary
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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)).
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Detailed Description
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Conditions
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Study Groups
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Arm A: Systematic surgery
Systematic surgery
Arm B: Surveillance and rescue surgery in cases of resectable
Surveillance and rescue surgery in cases of resectable loco-regional recurrence
Interventions
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Systematic surgery
Surveillance and rescue surgery in cases of resectable loco-regional recurrence
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
18 Years
75 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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CHU Amiens
Amiens, , France
Centre d'oncologie et de radiothérapie du Pays Basque
Bayonne, , France
CH de la Côte Basque
Bayonne, , France
Boulogne Sur Mer
Boulogne-sur-Mer, , France
Infirmerie protestante de Lyon
Caluire-et-Cuire, , France
Hôpitaux civils de Colmar
Colmar, , France
CHU de DIJON
Dijon, , France
Hôpital Michallon (GRENOBLE)
La Tronche, , France
Centre Oscar Lambret
Lille, , France
Hôpital Claude Huriez
Lille, , France
Clinique Chenieux
Limoges, , France
CHU de Limoges
Limoges, , France
CH Saint Joseph Saint Luc
Lyon, , France
Hôpital privé Jean Mermoz
Lyon, , France
Institut Mutualiste MONTSOURIS
Paris, , France
Centre Hospitalier Annecy Genevois
Pringy, , France
CHP Saint Grégoire
Saint-Grégoire, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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Bedenne PHRC N 2013
Identifier Type: -
Identifier Source: org_study_id
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