STATEC

CONTACT INFORMATION
STATEC-NL email: STATEC@og.umcg.nl
STATEC-NL telephone: 0625649880
Local trial coordination: trialburau@iknl.nl
Monitoring: monitor@iknl.nl
Versie 1 / 31-05-2018
RANDOMISATION WEBSITE
https://online.ctc.ucl.ac.uk/

STATEC Zorgpad

INCLUSION CRITERIA

  • Histologically confirmed high risk apparent FIGO stage I endometrial cancer according to one of the following criteria. Confirmation must be based on either diagnostic endometrial sampling OR hysterectomy and BSO specimen if randomisation occurring after hysterectomy and BSO:
    – FIGO grade 3 endometrioid or mucinous carcinoma
    – High grade serous, clear cell, undifferentiated or dedifferentiated carcinoma or mixed cell adenocarcinoma or carcinosarcoma
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • Age > 16 years
  • Adequate organ and bone marrow function as follows:
    – Absolute neutrophil count > 1.5 x 109/l
    – Platelet count > 100 x 109/l
    – Haemoglobin > 95 g/L
    – Bilirubin < 2 x upper limit of normal
    – AST or ALT < 2 x upper limit of normal
    – Serum creatinine < 1.5 x upper limit of normal
    – Serum urea < 1.5 x upper limit of normal
    – Calculated creatinine clearance (GFR) > 30 ml/min estimated using a validated creatinine clearance calculation e.g. Cockcroft-Gault or Wright formula
  • Written informed consent

EXCLUSION CRITERIA

  • Grossly enlarged node(s) of ³ 10mm short axis on baseline radiological imaging
  • Invasion of the cervical stroma on baseline radiological imaging or obvious cervical disease on clinical examination
  • Involvement of uterine serosa or metastatic disease seen outside the uterus on baseline radiological imaging
  • Small cell carcinoma with neuroendocrine differentiation
  • Concurrent anti-cancer therapy
  • Previous malignancy < 5 years prior to randomisation or concurrent malignant disease with the exception of:
    – carcinoma in situ of cervix
    – non-melanoma skin cancer
    – basal cell carcinoma
  • melanoma in situ
  • Women who are pregnant or lactating

Presentatie kick-off STATEC_general
Presentatie kick-off STATEC_side study
Presentatie kick-off STATEC _praktische uitvoering

UK onderzoeksprotocol v2 dd 13-12-2016
DGOG STATEC group specific appendix – v2 04-12-2017
STATEC Additional guidance for site staff  V1.0 20.03.18
STATEC Adjuvant Treatment Guidance v2.0 – 25jan18
QA Manual versie 1, dd 13-12-2016
Biospecimen Sampling Manual
STATEC – SAE Report Template – v1.1. 01jun18 – adapted for DGOG

Informatiebrief versie 2 MASTERVERSIE, STATEC, dd04-12-17
Informatiebrief SLN substudie versie 2 STATEC dd 04-12-2017
Toestemmingsformulier versie 2 MASTERVERSIE, STATEC, dd10-8-17
Toestemmingsformulier SLN substudie versie 2 MASTERVERSIE, dd 04-12-2017

Vragenlijsten  versie A versie 1 dd24-01-2017
Vragenlijsten versie B versie 1 dd24-01-2017
Vragenlijsten versie C versie 1 dd24-01-2017