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

Conditions: Endometrial carcinoma
MedDRA version: 9.1Level: LLTClassification code 10014738Term: Endometrial cancer stage I
MedDRA version: 9.1Level: LLTClassification code 10014739Term: Endometrial cancer stage II
MedDRA version: 9.1Level: LLTClassification code 10014740Term: Endometrial cancer stage III

Registration Number: EUCTR2007-004917-33-AT

Lead Sponsor: eiden University Medical Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 800

Inclusion Criteria

Histologically confirmed endometrial carcinoma, grade of differentiation determined according to the FIGO/AFIP criteria, with one of the following postoperative FIGO stages and grades:
1. Stage IB grade 3 with documented lymph-vascular space invasion (LVSI)
2. Stage IC or IIA grade 3
3. Stage IIB
4. Stage IIIA* or IIIC *IIIA based on peritoneal cytology alone is only eligible if grade 3
5. Stage IB, IC, II or III with serous or clear cell histology
6. Recommended surgery is TAH-BSO (total abdominal hysterectomy and bilateral salpingo-oophorectomy).
7. WHO-performance status 0-2
8. WBC = 3.0 x 109/L.
9. Platelets = 100 x 109/L.
10. Bilirubin = 1.5 x UNL
11. ASAT/ALAT = 2.5 x UNL
12. Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Uterine sarcoma
2. History of any previous malignancy, except for basal cell carcinoma of the skin, within the last 10 years (and if previous malignancy > 10 years ago there should be no evidence of recurrence)
3. Previous pelvic radiotherapy
4. Hormonal therapy or chemotherapy for this tumor
5. Macroscopic stage IIB for which radical (Wertheim type) hysterectomy has been performed
6. Prior diagnosis of Crohn’s disease or ulcerative colitis
7. Residual macroscopic tumor after surgery
8. Impaired renal function: creatinine clearance = 60 ml/min (calculated according to Cockroft) or = 50 ml/min (EDTA clearance, or measured creatinine clearance)
9. Impaired cardiac function, which in the assessment of the investigator would prohibit the infusion of large amounts of fluid during cisplatin therapy
10. Peripheral Neuropathy > grade 2