Clinical trial NCT02551458: Comparison of Systematic Surgery Versus Surveillance and Rescue Surgery in Operable Oesophageal Cancer With a Complete Clinical Response to Radiochemotherapy
Official title: SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
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
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT

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)).


Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of surviving patients
timeFrame: 1 year after randomisation
measure: Disease-free survival
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Bayonne
country: France
facility: Centre d'oncologie et de radiothérapie du Pays Basque
city: Bayonne
country: France
facility: CH de la Côte Basque
city: Boulogne-sur-mer
country: France
facility: Boulogne Sur Mer
city: Caluire et Cuire
country: France
facility: Infirmerie protestante de Lyon
city: Colmar
country: France
facility: Hôpitaux civils de Colmar
city: Dijon
country: France
facility: CHU de DIJON
city: La Tronche
country: France
facility: Hôpital Michallon (GRENOBLE)
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Limoges
country: France
facility: Clinique Chenieux
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: CH Saint Joseph Saint Luc
city: Lyon
country: France
facility: Hôpital privé Jean Mermoz
city: Paris
country: France
facility: Institut Mutualiste MONTSOURIS
city: Pringy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Saint Gregoire
country: France
facility: CHP Saint Grégoire
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: