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

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0

Adenocarcinoma of the Thoracic Oesophagus or

Adenocarcinoma of the Oesogastric Junction (Siewert Type I or II)

Epidermoid Carcinoma or

Treatments

Other: Surveillance and rescue surgery in cases of resectable loco-regional recurrence

Other: Systematic surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02551458

Bedenne PHRC N 2013

Details and patient eligibility

About

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)).

Enrollment

188 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)