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

Phase 3

Completed

• Conditions: Endometrial carcinoma; Cancer

• Registration Number: ISRCTN14387080
• Lead Sponsor: eiden University Medical Center (LUMC) (The Netherlands)

Brief Summary

2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27397040 results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29190319 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31345626 results (added 30/07/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32749941/ results of correlation between molecular subgroup and prognosis (added 05/03/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34903431/ Radiotherapy Quality Assurance (added 21/04/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-28
• Study Completion: 2020-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 686

Inclusion Criteria

1. Histologically confirmed endometrial carcinoma, with one of the following postoperative International Federation of Gynecology and Obstetrics (FIGO 1988) stages and grade:
1.1. Stage IB grade 3 with documented Lymphatic Vascular Space Invasion (LVSI)
1.2. Stage 1C grade 3
1.3. Stage II grade 3
1.4. Stage IIIA or IIIC (IIIA based on peritoneal cytology alone is only eligible if grade 3)
1.5. 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) more than or equal to 3.0 x 10^9/L
4. Platelets more 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

As of 11/02/2011 the criteria has been updated to also include the new FIGO 2009 staging system:
Histologically confirmed endometrial carcinoma, 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 histology

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