Randomised phase III trial comparing concurrent chemoradiation and adjuvant chemotherapy with pelvic radiation alone in high risk and advanced stage endometrial carcinoma: PORTEC-3

Phase 3

Active, not recruiting

• Conditions: Endometrial carcinoma; Cancer - Womb (Uterine or endometrial cancer)

• Registration Number: ACTRN12609000369224
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-27
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 680

Inclusion Criteria

1. Histologically confirmed endometrial carcinoma, with one of the following postoperative International Federation of Gynecology and Obstetrics (FIGO) stages and grade:
a. Stage IB grade 3 with documented Lymphatic Vascular Space Invasion (LVSI)
b. Stage 1C grade 3
c. Stage II grade 3
d. Stage IIIA or IIIC (IIIA based on peritoneal cytology alone is only eligible if grade 3)
e. Stage IB or IC, stage II or stage III with serous or clear cell histology
2. World Health Organisation (WHO) performance status zero to two
3. White Blood Cells (WBC) greater than or equal to 3.0 x 10^9/L
4. Platelets greater than or equal to 100 x 10^9/L
5. Bilirubin less than or equal to 1.5 x Upper Normalised Limit (UNL)
6. Aspartate Aminotransferase (ASAT)/Alanine Aminotreansferase (ALAT) less than or equal to 2.5 x UNL
7. Written informed consent

Exclusion Criteria

1. Previous malignancy, except for basal cell carcinoma of the skin, less than ten years
2. Previous pelvic radiotherapy
3. Hormonal therapy or chemotherapy for this tumor
4. Macroscopic stage IIB for which Wertheim type hysterectomy
5. Prior diagnosis of Crohn's disease or ulcerative colitis
6. Residual macroscopic tumor after surgery
7. Creatinine clearance less than or equal to 60 ml/min (calculated according to Cockroft) or less than or equal to 50 ml/min (EthyleneDiamineTetraacetic Acid [EDTA] clearance, or measured creatinine clearance)
8. Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy
9. Peripheral Neuropathy more than or equal to grade two

Study & Design

• Study Type: Interventional
• Study Design: Not specified