Endometrial carcinoma
Conditions
Interventions
Patients are randomized to receive external beam pelvic radiotherapy (standard arm: 46 Gy in 2 Gy fractions in 5 weeks) or vaginal brachytherapy (study arm: HDR 21 Gy in 3 fractions of 7 Gy, each 1 we
or MDR 28 Gy in one session
or LDR 30 Gy in one session).
Sponsors
Leiden University Medical Center,
Department of Clinical Oncology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Endometrial carcinoma, with one of the following combinations of postoperative FIGO stage and age: a. Stage 1C grade 1 or 2 and age 60 or over; b. Stage 1B grade 3 and age 60 or over; c. Stage 2A, any age, grade 1 or 2; d. Stage 2A, any age, grade 3 with < ½ myometrial invasion; 2. Surgery consisted of a total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH-BSO); 3. Histologically proven adenocarcinoma; grade of differentiation determined according to the FIGO/AFIP criteria; depth of myometrial invasion documented; 4. WHO-performance status 0-2; 5. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. One of the following combinations of FIGO stage and age: a. Stage 2B, 3 or 4; b. Stage 2A and grade 3 with 50% or greater myometrial invasion; c. Stage IA or IB grade 1 or 2; d. Stage 1B grade 3 and age below 60; e. Stage 1C grade 1 or 2 and age below 60; f. Stage IC grade 3, any age; 2. Histological subtypes papillary serous carcinoma or clear cell carcinoma; 3. Routine staging lymphadenectomy; 4. Interval between the operation and start of radiotherapy exceeding 8 weeks; 5. History of any previous malignancy, except for basal cell carcinoma of the skin; 6. Previous pelvic radiotherapy; 7. Hormonal therapy or chemotherapy for this tumour; 8. Prior diagnosis of Crohn’s disease or ulcerative colitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year actuarial vaginal relapse. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 5-year overall survival and cancer-specific survival; 2. quality of life and treatment related morbidity; 3. 5-year rates of pelvic and distant relapse; 4. Local control and survival after relapse. | — |
Contacts
Public ContactC.L. Creutzberg
Leiden University Medical Center (LUMC), Department of Clinical Oncology, P.O. Box 9600
Outcome results
None listed