A III Trial Comparing Chemotherapy and Radiotherapy against Radiotherapy alone in patients with High Risk and Advanced Uterus cancer.
- Conditions
- Endometrial carcinomaMedDRA version: 14.1Level: PTClassification code 10014740Term: Endometrial cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10014739Term: Endometrial cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10014738Term: Endometrial cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2007-004917-33-GB
- 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
- 670
1. Histologically confirmed endometrial carcinoma, grade of differentiation determined according to the
FIGO/AFIP criteria, with one of the following postoperative FIGO 2009 stages45 (Appendix B); confirmed
at pathology review (see section 8.1):
a. Stage IA with myometrial invasion, grade 3 with documented lymph-vascular space invasion (LVSI)
b. Stage IB grade 3
c. Stage II
d. Stage IIIA or IIIC; or IIIB if parametrial invasion
e. Stage IA with myometrial invasion, IB, II or IIIA/C with serous or clear cell histology
During the initial years of the trial, FIGO 1988 staging was used (see Appendix B). Criteria using FIGO
1988 staging:
a. Stage IB grade 3 with documented lymph-vascular space invasion (LVSI)
b. Stage IC or IIA grade 3
c. Stage IIB
d. Stage IIIA* or IIIC *IIIA based on peritoneal cytology alone is only eligible if grade 3
e. Stage IB, IC, II or III with serous or clear cell histology
2. Recommended surgery is TAH-BSO (total abdominal hysterectomy and bilateral salpingooophorectomy).
However, for a patient who has had laparoscopic surgery, and/or lymphadenectomy
and/or full surgical staging, and was found after pathology diagnosis to meet the eligibility criteria,
inclusion in the trial is permitted.
3. WHO-performance status 0-2 (Appendix C)
4. WBC = 3.0 x 109/L.
5. Platelets = 100 x 109/L.
6. Bilirubin = 1.5 x UNL
7. ASAT/ALAT = 2.5 x UNL
8. 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 335
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 335
1. Uterine sarcoma
2. Previous malignancy, except for basal cell carcinoma of the skin < 10 years
3. Previous pelvic radiotherapy
4. Hormonal therapy or chemotherapy for this tumor
5. Macroscopic stage IIB for which 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, prohibiting the infusion of large amounts of fluid during cisplatin therapy
10. Peripheral Neuropathy > grade 2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): 1. 5-year actuarial overall survival<br>2. 5-year actuarial failure-free survival. <br>Failure is defined as relapse or death due to endometrial carcinoma or due to treatment complications;Timepoint(s) of evaluation of this end point: 5 years after randomisation;Main Objective: Establish overall survival and failure-free survival of patients with high-risk and advanced stage endometrial carcinoma, treated after surgery with concurrent radiotherapy and chemotherapy, followed by adjuvant chemotherapy, in comparison with patients treated with pelvic radiation alone. ;Secondary Objective: 1. Establish and compare rates of treatment-related toxicity<br>2. Rates of local relapse<br>3. Rates of distant metastases<br>4. Quality of Life
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Relapse free survival, <br>2. Overall locoregional failure<br>3. Overall distant failure;Timepoint(s) of evaluation of this end point: 5 years after randomisation