ENdometrial cancer SURvivors’ follow-up carE (ENSURE): Less is more?

Randomized controlled trial to evaluate patient satisfaction and cost-effectiveness of a reduced follow-up schedule

Inclusiecriteria

  1. Patients with endometrioïd type endometrial carcinoma with stage 1 (FIGO, 2009) disease, with the following combination of stage, age and grade:
    • Stage 1A, any age, grade 1 or 2;
    • Stage 1B, < 60 years, grade 1 or 2 without LVSI;
  2. Written informed consent;
  3. Sufficient oral and written command of the Dutch language.

Exclusiecriteria

  1. Any other stage and type of endometrial carcinoma
  2. Histological types papillary serous carcinoma or clear cell carcinoma
  3. Uterine sarcoma (including carcinosarcoma)
  4. Radiotherapy for current endometrial carcinoma
  5. Previous malignancy (except for non-melanomatous skin cancer) < 5 yrs
  6. Having metastases of other tumours;
  7. Confirmed Lynch syndrome
  8. Previous pelvic radiotherapy

Randomisatie

Intervention: 4 follow-up visits, after 3, 12, 24 and 36 months

Control: regular follow-up  according to the guideline, 10-13 visits during 5 years

Flowchart

Aanvullende onderzoeken bij randomisatie of tijdens studie

Nee

Contactgegevens

Coordinating investigator

Dr. Nicole Ezendam, Netherlands Comprehensive Cancer Organisation (IKNL), Tilburg University

Tel. 088 2346096; email: n.ezendam@iknl.nl

Datamanagement and randomisation

IKNL clinical research department

E-mail: trialbureau@iknl.nl

Tel. 088 234 6500

Controle factsheet: 17 maart 2017

Documenten

 Informatie over deelnemende centra hier te vinden.