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

Inclusie criteria

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.

Exclusie criteria

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

 

Contact gegevens

Coordinating investigator

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

Tel.: 088 2346096; email: Dit e-mailadres wordt beveiligd tegen spambots. JavaScript dient ingeschakeld te zijn om het te bekijken.


Datamanagement and randomisation

IKNL clinical research department

Email: Dit e-mailadres wordt beveiligd tegen spambots. JavaScript dient ingeschakeld te zijn om het te bekijken.

Tel.: 088 234 6500

Controle factsheet: 17 maart 2017


Documenten:

Protocol

patienten informatie

Inclusie en organisatie informatie

Samenvatting

 Informatie over deelnemende centra hier te vinden

 Controle factsheet: 17 maart 2017