Status:
UNKNOWN
Randomized Trial of Radiation Therapy With or Without Chemotherapy for Endometrial Cancer
Lead Sponsor:
Leiden University
Collaborating Sponsors:
Cancer Research UK
Australia New Zealand Gynaecological Oncology Group
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18-90 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from di...
Detailed Description
OBJECTIVES: Primary * Compare the overall survival and failure-free survival of patients with high-risk stage IB-III endometrial carcinoma treated with concurrent chemoradiotherapy followed by adjuv...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed endometrial carcinoma, with one of the following postoperative FIGO 2009 stages and grade:
- stage IA with invasion, grade 3 with documented LVSI
- stage IB grade 3
- stage II
- stage IIIA or IIIC; or IIIB if parametrial invasion only
- stage IA (with invasion), IB, II, or III with serous or clear cell histology
- WHO-performance status 0-2
- WBC ≥ 3.0 x 109/L.
- Platelets ≥ 100 x 109/L.
- Bilirubin ≤ 1.5 x UNL
- ASAT/ALAT ≤ 2.5 x UNL
- Written informed consent
- Exclusion criteria:
- 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 \> or = grade 2
- Hearing impairment \> or = grade 3, or born deaf
Exclusion
Key Trial Info
Start Date :
November 23 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT00411138
Start Date
November 23 2006
End Date
December 31 2024
Last Update
October 11 2023
Active Locations (1)
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1
Leiden University Medical Center
Leiden, Netherlands, 2300 RC