Content - Prodige 32

Prodige 32 - Surgery or very close follow-up checks for patients with advanced oesophageal cancer

In this trial, patients with advanced oesophageal cancer who show no further signs of a tumor following chemotherapy and radiotherapy, either undergo surgery as usual or receive very close follow-up checks. If the patients who did not undergo surgery experience a local tumor recurrence, they will also receive surgery.

Patients with locally advanced oesophageal cancer usually undergo surgery following the standard treatment with chemotherapy and radiotherapy. During this operation, the oesophagus is almost completely removed and replaced by a gastric pull-up. After this highly demanding operation, which has a very high rate of complications, eating will be more difficult than before. Patients can often only eat their meals in small portions, at least in the first two years after the operation.

In this trial, we are examining whether when surgery is delayed and close follow-up checks made, the risk of recurrence is small enough compared with direct surgery to warrant further investigation of this therapy option. This is aimed at preventing potential overtreatment. 

Studychair:

PD Dr. med. Thomas Ruhstaller, Cantonal Hospital of St.Gallen, +41 71 494 20 82

  • Contacts at the hospitals

  • Inclusion criteria

    • Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic oesophagus or gastroesophageal junction adenocarcinoma (Siewert type I or II),

    • Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0 following a full assessment

    • Patient deemed operable curative-intent and programmed for first chemoradiotherapy following multidisciplinary meeting

    • Age ≥ 18 years < 75 years

    • Patient affiliated to a social security scheme and who has signed the informed consent form for clinical and biological studies.

  • Exclusion criteria

    • Cancer of the cervical esophagus (15 to 19 cm from the dental arches)

    • Weight loss at registration > 15 % without recovery after nutritional care

    • Severe comorbidity threatening short-term life prognosis

    • Contraindication to chemoradiation

    • Other malignant disease uncured in the previous 5 years (except carcinoma in situ of the cervix and non-melanoma treated skin cancers)

    • Lack of effective contraception in patients (male or female) of reproductive age, pregnant or nursing women,

    • Impossibility of monitoring the trial

    • Legal incapacity (Persons deprived of liberty or under guardianship)

Locations for this trial:

Kantonsspital Baden
Im Ergel 1
4600 Baden
Universitätsspital Basel
Petersgraben 4
0 4031 Basel
Istituto Oncologico della Svizzera Italiana IOSI
Via Ospedale
0 6500 Bellinzona
Kantonsspital Graubünden
Loëstrasse 170
7000 Chur
Hôpital Fribourgeois HFR
Chemin des Pensionnats 2
1708 1708 Fribourg
Hôpitaux Universitaires de Genève HUG
Rue Gabrielle-Perret-Gentil 4
0 1205 Genève
Kantonsspital Luzern
Spitalstrasse
0 6000 Luzern
Kantonsspital St. Gallen
Rorschacher Strasse 95
0 9007 St. Gallen
Kantonsspital Winterthur
Brauerstrasse 15
0 8401 Winterthur
Stadtspital Triemli
Birmensdorferstrasse 497
0 8063 Zürich