Comparison of Systematic Surgery Versus Surveillance and Rescue Surgery in Operable Oesophageal Cancer With a Complete Clinical Response to Radiochemotherapy

Phase 2

Terminated

• Conditions: Adenocarcinoma of the Oesogastric Junction (Siewert Type I or II); Epidermoid Carcinoma or; Adenocarcinoma of the Thoracic Oesophagus or; Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0
• Interventions: Other: Surveillance and rescue surgery in cases of resectable loco-regional recurrence; Other: Systematic surgery

• Registration Number: NCT02551458
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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.

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)).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-16
• Study Start: 2016-03-14
• Primary Completion: 2023-03-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 188

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm B: Surveillance and rescue surgery in cases of resectable	Surveillance and rescue surgery in cases of resectable loco-regional recurrence	-
Arm A: Systematic surgery	Systematic surgery	-

Primary Outcome Measures

Name	Time	Method
Disease-free survival	Up to 5 years
Proportion of surviving patients	1 year after randomisation

Trial Locations

Locations (18)

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 Claude Huriez; 🇫🇷 Lille, France

Hôpital Michallon (GRENOBLE); 🇫🇷 La Tronche, France

Centre Oscar Lambret; 🇫🇷 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 Gregoire, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France