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

Conditions

Adenocarcinoma of the Oesogastric Junction (Siewert Type I or II), Adenocarcinoma of the Thoracic Oesophagus or, Epidermoid Carcinoma or, Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0

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)).

Charlène J. van der Zijden, Sjoerd M. Lagarde, Merel Hermus, Leonieke W. Kranenburg, J. Jan B. van Lanschot et al. (24 authors)

BMC Cancer2023-04-1024 citations

10.1186/s12885-023-10747-z

Accuracy of detecting residual disease after neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma (preSINO trial): a prospective multicenter diagnostic cohort study.

Zhang X, Eyck BM, Yang Y, Liu J, Chao YK, Hou MM, Hung TM, Pang Q, Yu ZT, Jiang H, Law S, Wong I, Lam KO, van der Wilk BJ, van der Gaast A, Spaander MCW, Valkema R, Lagarde SM, Wijnhoven BPL, van Lanschot JJB, Li Z, Li Z.

2020-03-0632 citations

10.1186/s12885-020-6669-y

Preoperative image-guided identification of response to neoadjuvant chemoradiotherapy in esophageal cancer (PRIDE): a multicenter observational study.

Borggreve AS, Mook S, Verheij M, Mul VEM, Bergman JJ, Bartels-Rutten A, Ter Beek LC, Beets-Tan RGH, Bennink RJ, van Berge Henegouwen MI, Brosens LAA, Defize IL, van Dieren JM, Dijkstra H, van Hillegersberg R, Hulshof MC, van Laarhoven HWM, Lam MGEH, van Lier ALHMW, Muijs CT, Nagengast WB, Nederveen AJ, Noordzij W, Plukker JTM, van Rossum PSN, Ruurda JP, van Sandick JW, Weusten BLAM, Voncken FEM, Yakar D, Meijer GJ, PRIDE study group.

2018-10-2043 citations

10.1186/s12885-018-4892-6

Interventions

OTHERSystematic surgery

OTHERSurveillance and rescue surgery in cases of resectable loco-regional recurrence

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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)

Design outcomes

Primary

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

Countries

France

Outcome results

None listed