Adenocarcinoma of the Oesogastric Junction (Siewert Type I or II) Clinical Trial
— EsostrateOfficial title:
SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY
| NCT number | NCT02551458 |
| Other study ID # | Bedenne PHRC N 2013 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 2/Phase 3 |
| First received | |
| Last updated | |
| Start date | March 14, 2016 |
| Verified date | March 2024 |
| Source | Centre Hospitalier Universitaire Dijon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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)).
| Status | Terminated |
| Enrollment | 188 |
| Est. completion date | |
| Est. primary completion date | March 15, 2023 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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) |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 | CHU de Limoges | Limoges | |
| France | Clinique Chenieux | 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 Gregoire | |
| France | Institut Gustave Roussy | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of surviving patients | 1 year after randomisation | ||
| Primary | Disease-free survival | Up to 5 years |