Randomized Trial of Radiation Therapy With or Without Chemotherapy for Endometrial Cancer
NCT ID: NCT00411138
Last Updated: 2023-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
670 participants
INTERVENTIONAL
2006-11-23
2024-12-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying chemotherapy and radiation therapy to see how well they work compared with radiation therapy alone in treating patients with high-risk, stage I, stage II, or stage III endometrial cancer.
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Detailed Description
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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 adjuvant chemotherapy vs pelvic radiotherapy alone.
Secondary
* Compare the rates of pelvic and distant recurrence, severe (grades 3 and 4) treatment-related toxicity, and quality of life of patients treated with these regimens.
OUTLINE:
This is a multicenter, prospective, open-label, randomized, controlled study. Patients are stratified according to participating group (DGOG vs UK NCRI vs NCIC CTG vs MaNGO vs Unicancer), type of surgery (total abdominal hysterectomy and bilateral salpingo-oophorectomy \[TAH-BSO\] vs TAH-BSO plus lymphadenectomy vs laparoscopic hysterectomy \[TLH-BSO\] vs TLH-BSO plus lymphadenectomy), stage (IA vs IB vs II vs III), and histological type (endometrioid carcinoma vs serous or clear cell carcinoma). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive external-beam pelvic radiotherapy 5 days a week for up to 6 weeks, combined with cisplatin IV days 1 and 22. Patients with cervical involvement undergo vaginal brachytherapy boost. At least 3 weeks after completion of chemoradiotherapy, patients undergo adjuvant chemotherapy comprising paclitaxel IV and carboplatin IV on day 1. Adjuvant chemotherapy repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients undergo external-beam pelvic radiotherapy (and vaginal brachytherapy alone in case of cervical involvement) as in arm I.
Quality of life is assessed at baseline, completion of radiotherapy, completion of chemotherapy, at 6 months, and then once a year for 5 years.
After completion of study therapy, patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: A total of 670 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiation Therapy
Pelvic Radiotherapy alone
Radiation Therapy
External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions) Vaginal brachytherapy boost in case of cervical involvement
Radiation Therapy and Chemotherapy
Pelvic Radiation plus 2 concurrent cycles cisplatin followed by 4 adjuvant cycles carboplatin and paclitaxel
Radiation Therapy
External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions) Vaginal brachytherapy boost in case of cervical involvement
cisplatin
cisplatin 50 mg/m2 i.v., 2 cycles during radiotherapy, 3 wks interval
carboplatin
carboplatin AUC 5, 4 cycles after completion of radiotherapy, 3 wks interval
Paclitaxel
paclitaxel 175 mg/m2, 4 cycles after completion of radiotherapy, 3 wks interval
Interventions
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Radiation Therapy
External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions) Vaginal brachytherapy boost in case of cervical involvement
cisplatin
cisplatin 50 mg/m2 i.v., 2 cycles during radiotherapy, 3 wks interval
carboplatin
carboplatin AUC 5, 4 cycles after completion of radiotherapy, 3 wks interval
Paclitaxel
paclitaxel 175 mg/m2, 4 cycles after completion of radiotherapy, 3 wks interval
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. stage IA with 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 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
* 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
18 Years
90 Years
FEMALE
No
Sponsors
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Cancer Research UK
OTHER
Australia New Zealand Gynaecological Oncology Group
OTHER
NCIC Clinical Trials Group
NETWORK
Mario Negri Institute for Pharmacological Research
OTHER
UNICANCER
OTHER
Leiden University
OTHER
Responsible Party
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Carien Creutzberg
Chief Investigator
Principal Investigators
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Carien L. Creutzberg, MD, PhD
Role: STUDY_CHAIR
Leiden University Medical Center
Locations
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Leiden University Medical Center
Leiden, , Netherlands
Countries
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References
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Jameson MG, McNamara J, Bailey M, Metcalfe PE, Holloway LC, Foo K, Do V, Mileshkin L, Creutzberg CL, Khaw P. 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. Epub 2016 Apr 5.
ANZGOG and PORTEC Group; Blinman P, Mileshkin L, Khaw P, Goss G, Johnson C, Capp A, Brooks S, Wain G, Kolodziej I, Veillard AS, O'Connell R, Creutzberg CL, Stockler MR. Patients' and clinicians' preferences for adjuvant chemotherapy in endometrial cancer: an ANZGOG substudy of the PORTEC-3 intergroup randomised trial. Br J Cancer. 2016 Nov 8;115(10):1179-1185. doi: 10.1038/bjc.2016.323. Epub 2016 Oct 20.
de Boer SM, Wortman BG, Bosse T, Powell ME, Singh N, Hollema H, Wilson G, Chowdhury MN, Mileshkin L, Pyman J, Katsaros D, Carinelli S, Fyles A, McLachlin CM, Haie-Meder C, Duvillard P, Nout RA, Verhoeven-Adema KW, Putter H, Creutzberg CL, Smit VTHBM; for PORTEC Study Group. 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. doi: 10.1093/annonc/mdx753.
de Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger PB, Ledermann JA, Khaw P, Colombo A, Fyles A, Baron MH, Kitchener HC, Nijman HW, Kruitwagen RF, Nout RA, Verhoeven-Adema KW, Smit VT, Putter H, Creutzberg CL; PORTEC study group. 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):1114-1126. doi: 10.1016/S1470-2045(16)30120-6. Epub 2016 Jul 7.
de Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger PB, Ledermann JA, Khaw P, Colombo A, Fyles A, Baron MH, Jurgenliemk-Schulz IM, Kitchener HC, Nijman HW, Wilson G, Brooks S, Carinelli S, Provencher D, Hanzen C, Lutgens LCHW, Smit VTHBM, Singh N, Do V, D'Amico R, Nout RA, Feeney A, Verhoeven-Adema KW, Putter H, Creutzberg CL; PORTEC study group. 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, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger PB, Ledermann JA, Khaw P, D'Amico R, Fyles A, Baron MH, Jurgenliemk-Schulz IM, Kitchener HC, Nijman HW, Wilson G, Brooks S, Gribaudo S, Provencher D, Hanzen C, Kruitwagen RF, Smit VTHBM, Singh N, Do V, Lissoni A, Nout RA, Feeney A, Verhoeven-Adema KW, Putter H, Creutzberg CL; PORTEC Study Group. 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.
Post CCB, de Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger NPB, Ledermann JA, Khaw P, D'Amico R, Fyles A, Baron MH, Kitchener HC, Nijman HW, Lutgens LCHW, Brooks S, Jurgenliemk-Schulz IM, Feeney A, Goss G, Fossati R, Ghatage P, Leary A, Do V, Lissoni AA, McCormack M, Nout RA, Verhoeven-Adema KW, Smit VTHBM, Putter H, Creutzberg CL. 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.
Leon-Castillo A, de Boer SM, Powell ME, Mileshkin LR, Mackay HJ, Leary A, Nijman HW, Singh N, Pollock PM, Bessette P, Fyles A, Haie-Meder C, Smit VTHBM, Edmondson RJ, Putter H, Kitchener HC, Crosbie EJ, de Bruyn M, Nout RA, Horeweg N, Creutzberg CL, Bosse T; TransPORTEC consortium. Molecular Classification of the PORTEC-3 Trial for High-Risk Endometrial Cancer: Impact on Prognosis and Benefit From Adjuvant Therapy. J Clin Oncol. 2020 Oct 10;38(29):3388-3397. doi: 10.1200/JCO.20.00549. Epub 2020 Aug 4.
Post CCB, Stelloo E, Smit VTHBM, Ruano D, Tops CM, Vermij L, Rutten TA, Jurgenliemk-Schulz IM, Lutgens LCHW, Jobsen JJ, Nout RA, Crosbie EJ, Powell ME, Mileshkin L, Leary A, Bessette P, Putter H, de Boer SM, Horeweg N, Nielsen M, Wezel TV, Bosse T, Creutzberg CL. Prevalence and Prognosis of Lynch Syndrome and Sporadic Mismatch Repair Deficiency in Endometrial Cancer. J Natl Cancer Inst. 2021 Sep 4;113(9):1212-1220. doi: 10.1093/jnci/djab029.
Wortman BG, Post CCB, Powell ME, Khaw P, Fyles A, D'Amico R, Haie-Meder C, Jurgenliemk-Schulz IM, McCormack M, Do V, Katsaros D, Bessette P, Baron MH, Nout RA, Whitmarsh K, Mileshkin L, Lutgens LCHW, Kitchener HC, Brooks S, Nijman HW, Astreinidou E, Putter H, Creutzberg CL, de Boer SM. Radiation Therapy Techniques and Treatment-Related Toxicity in the PORTEC-3 Trial: Comparison of 3-Dimensional Conformal Radiation Therapy Versus Intensity-Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. 2022 Feb 1;112(2):390-399. doi: 10.1016/j.ijrobp.2021.09.042. Epub 2021 Oct 2.
Khaw P, Do V, Lim K, Cunninghame J, Dixon J, Vassie J, Bailey M, Johnson C, Kahl K, Gordon C, Cook O, Foo K, Fyles A, Powell M, Haie-Meder C, D'Amico R, Bessette P, Mileshkin L, Creutzberg CL, Moore A. Radiotherapy Quality Assurance in the PORTEC-3 (TROG 08.04) Trial. Clin Oncol (R Coll Radiol). 2022 Mar;34(3):198-204. doi: 10.1016/j.clon.2021.11.015. Epub 2021 Dec 11.
Post CCB, de Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Leary A, Ottevanger PB, McCormack M, Khaw P, D'Amico R, Fyles A, Chargari C, Kitchener HC, Do V, Lissoni A, Provencher D, Genestie C, Nijman HW, Whitmarsh K, Jurgenliemk-Schulz IM, Feeney A, Lutgens LCHW, Bouma J, Leon-Castillo A, Nout RA, Putter H, Bosse T, Creutzberg CL. Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): 10-year clinical outcomes and post-hoc analysis by molecular classification from a randomised phase 3 trial. Lancet Oncol. 2025 Oct;26(10):1370-1381. doi: 10.1016/S1470-2045(25)00379-1. Epub 2025 Sep 5.
Related Links
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Publication on Toxicity and Quality of life outcomes of the PORTEC-3 trial
trial website (with protocol and all documents)
Other Identifiers
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CKTO-2006-04
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ISRCTN14387080
Identifier Type: REGISTRY
Identifier Source: secondary_id
P06.031-PORTEC-3
Identifier Type: OTHER
Identifier Source: secondary_id
2007-004917-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CDR0000521447; P06.031
Identifier Type: -
Identifier Source: org_study_id
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