Endometrial cancer is the seventh most common cancer in women and the most common gynaecological malignancy in the developed world. The Dutch PORTEC (Postoperative Radiation Therapy in Endometrial Cancer) and British ASTEC (A Study in the Treatment of Endometrial Cancer; combined with data from the Canadian study EN.5) randomised controlled trials both demonstrated the efficacy of pelvic radiotherapy in significantly reducing the risk of recurrence of stage 1 endometrial cancers within the pelvis, but with no demonstrable effect on overall survival.
The aims of PORTEC 3 trial are:
- To establish overall survival and failure-free survival of patients with high-risk and advanced stage endometrial cancer, treated after surgery with concurrent radiotherapy and chemotherapy, followed by adjuvant chemotherapy compared to patients treated with pelvic radiation alone.
- To compare the rates of treatment-related toxicity, quality of life, and pelvic and distant recurrence.
a. Histologically confirmed endometrial cancer with one of the following
postoperative FIGO 2009 stages and grade:
1. stage IA with myometrial invasion, grade 3 with documented LVSI
2. stage IB grade 3
3. stage II
4. stage IIIA or IIIC; or IIIB if parametrial invasion only
5. stage IA (with myometrial invasion), IB, II, or III with serous or clear cell
b. WHO-performance status 0-2
c. WBC ≥ 3.0 x 109/L.
d. Platelets ≥ 100 x 109/L.
e. Bilirubin ≤ 1.5 x UNL
f. ASAT/ALAT ≤ 2.5 x UNL
g. Written informed consent
- Uterine sarcoma (including carcinosarcoma)
- Previous malignancy (except for non-melanomatous skin cancer) < 10 yrs
- Previous pelvic radiotherapy
- Hormonal therapy or chemotherapy for this tumor
- Macroscopic stage II for which Wertheim type hysterectomy (eligible if stage II grade 3 or stage III at pathology)
- Prior diagnosis of Crohn’s disease or ulcerative colitis
- Residual macroscopic tumor after surgery
- Creatinine clearance ≤ 60 ml/min (Cockroft) or ≤ 50 ml/min (EDTA clearance or measured creatinine clearance)
- Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy
- Peripheral Neuropathy > grade 2
- Hearing impairment > grade 3, or born deaf
Christos Iavazzo MD, MSc, PhD
Senior Clinical Fellow Gynaecological Oncology Department, Royal Surrey County Hospital, Guildford, United Kingdom