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

Completed

Conditions: Endometrial carcinoma

Registration Number: NL-OMON25773

Lead Sponsor: eiden University Medical Center (LUMC), Department of Clinical Oncology

Brief Summary: Wortman BG, Post CCB, Powell ME, et al. Radiotherapy Techniques and Treatment-Related Toxicity in the PORTEC-3 Trial: Comparison of Three-Dimensional Conformal Radiotherapy versus Intensity-Modulated Radiotherapy. Int J Radiat Oncol Biol Phys. 2021, in press. Post CCB, de Boer SM, Powell ME, et al. Long-Term Toxicity and Health-Related Quality of Life After Adjuvant Chemoradiation Therapy or Radiation Therapy Alone for High-Risk Endometrial Cancer in the Randomized PORTEC-3 Trial. Int J Radiat Oncol Biol Phys. 2021 Mar 15;109(4):975-986. doi: 10.1016/j.ijrobp.2020.10.030. Epub 2020 Oct 28. De Boer SM, Powell ME, Mileshkin L, et al. Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): patterns of recurrence and post-hoc survival analysis of a randomised phase 3 trial. Lancet Oncol. 2019 Sep;20(9):1273-1285. doi: 10.1016/S1470-2045(19)30395-X. Epub 2019 Jul 22. PMID: 31345626 De Boer SM, Powell ME, Mileshkin L, et al. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Mar;19(3):295-309. doi: 10.1016/S1470-2045(18)30079-2. Epub 2018 Feb 12 De Boer SM, Wortman BG, Bosse T, et al. Clinical consequences of upfront pathology review in the randomised PORTEC-3 trial for high-risk endometrial cancer. Ann Oncol. 2018 Feb 1;29(2):424-430 De Boer SM, Powell ME, Mileshkin L, et al. Toxicity and quality of life after adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1114-26. doi: 10.1016/S1470-2045(16)30120-6. Blinman P, Mileshkin L, Khaw P, et al. Patients' and clinicians' preferences for adjuvant chemotherapy in endometrial cancer: an ANZGOG substudy of the PORTEC-3 intergroup randomised trial. ANZGOG and PORTEC Group. Br J Cancer. 2016 Nov 8;115(10):1179-1185. doi: 10.1038/bjc.2016.323 Jameson MG, McNamara J, Bailey M, et al. Results of the Australasian (Trans-Tasman Oncology Group) radiotherapy benchmarking exercise in preparation for participation in the PORTEC-3 trial. J Med Imaging Radiat Oncol. 2016 Aug;60(4):554-9. doi: 10.1111/1754-9485.12447.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 500

Inclusion Criteria

1. Histologically confirmed endometrial carcinoma, with one of the following postoperative FIGO 2009 stages and grade:

A. Stage IA with myometrial invasion, grade 3 with documented LVSI;

Exclusion Criteria

1. Previous malignancy, except for basal cell carcinoma of the skin, < 10 yrs;
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 <= 60 ml/min (calculated according to Cockroft) or <= 50 ml/min (EDTA clearance, or measured creatinine clearance);
8. Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy;
9. Peripheral Neuropathy >= grade 2.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5-year actuarial overall suvival <br>5-year actuarial failure-free survival (with failure defined as relapse or death due to endometrial carcinoma or to treatment complications).

Secondary Outcome Measures