Randomised Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma: PORTEC-3.

Randomised Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25773

Enrollment

500

Registered

2006-07-10

Start date

2006-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial carcinoma

Interventions

Patients are randomised (1:1) to receive external beam pelvic radiotherapy (atandard arm

48.6 Gy in 1.8 Gy fractions), or pelvic radiotherapy with concurrent chemotherapy (2 cycles of cisplatin) followed by adjuvant chemotherapy (4 cycles of carboplatin and paclitaxel

experimental arm).

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed endometrial carcinoma, with one of the following postoperative FIGO 2009 stages and grade: A. Stage IA with myometrial invasion, grade 3 with documented LVSI; B. Stage IB grade 3; C. Stage II; D. Stage IIIA or IIIC; or IIIB if parametrial invasion only; E. Stage IA (with myometrial invasion), IB, II, or III with serous or clear cell histology. 2. WHO-performance status 0-2; 3. WBC >= 3.0 x 109/L; 4. Platelets >= 100 x 109/L; 5. Bilirubin <= 1.5 x UNL; 6. ASAT/ALAT <= 2.5 x UNL; 7. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous malignancy, except for basal cell carcinoma of the skin, = grade 2.

Design outcomes

Primary

Measure	Time frame
5-year actuarial overall suvival 5-year actuarial failure-free survival (with failure defined as relapse or death due to endometrial carcinoma or to treatment complications).	—

Secondary

Measure	Time frame
1. quality of life; 2. severe treatment related morbidity; 3. 5-year rates of vaginal, pelvic and distant relapse;	—

Contacts

Public ContactCarien L. Creutzberg

Leiden University Medical Center (LUMC)

c.l.creutzberg@lumc.nl+31 (0)71 5263027

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)