NCT00411138

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 dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving chemotherapy together with radiation therapy is more effective than giving radiation therapy alone in treating endometrial cancer. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
670

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2006

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2018

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

12 years

First QC Date

December 11, 2006

Last Update Submit

October 10, 2023

Conditions

Endometrial Cancer

Keywords

endometrial clear cell carcinomastage II endometrial carcinomastage IA grade 3 endometrial carcinomastage IB endometrial carcinomastage IIIA endometrial carcinomastage IIIB endometrial carcinomastage IIIC endometrial carcinoma

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    co-primary endpoint

    5 years

  • Failure-free survival

    co-primary endpoint

    5 years

Secondary Outcomes (4)

  • Quality of life by QLQ-C30 v3.0

    5 years

  • Severe treatment-related morbidity

    5 years

  • Vaginal or pelvic relapse

    5 years

  • Distant metastases

    5 years

Study Arms (2)

Radiation Therapy

ACTIVE COMPARATOR

Pelvic Radiotherapy alone

Radiation: Radiation Therapy

Radiation Therapy and Chemotherapy

EXPERIMENTAL

Pelvic Radiation plus 2 concurrent cycles cisplatin followed by 4 adjuvant cycles carboplatin and paclitaxel

Radiation: Radiation TherapyDrug: cisplatinDrug: carboplatinDrug: Paclitaxel

Interventions

Radiation TherapyRADIATION

External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions) Vaginal brachytherapy boost in case of cervical involvement

Also known as: RT, 3D conformal radiotherapy, IMRT, brachytherapy
Radiation TherapyRadiation Therapy and Chemotherapy
cisplatinDRUG

cisplatin 50 mg/m2 i.v., 2 cycles during radiotherapy, 3 wks interval

Also known as: Cisplatine
Radiation Therapy and Chemotherapy
carboplatinDRUG

carboplatin AUC 5, 4 cycles after completion of radiotherapy, 3 wks interval

Also known as: Carboplatine, Carbotaxol
Radiation Therapy and Chemotherapy
PaclitaxelDRUG

paclitaxel 175 mg/m2, 4 cycles after completion of radiotherapy, 3 wks interval

Also known as: Taxol, Taxolcarbo
Radiation Therapy and Chemotherapy

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Related Publications (12)

  • 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.

    PMID: 27059658BACKGROUND

  • 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.

    PMID: 27764842BACKGROUND

  • 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.

    PMID: 29190319RESULT

  • 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.

    PMID: 27397040RESULT

  • 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.

    PMID: 29449189RESULT

  • 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.

    PMID: 31345626RESULT

  • 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.

    PMID: 33129910RESULT

  • 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.

    PMID: 32749941RESULT

  • 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.

    PMID: 33693762RESULT

  • 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.

    PMID: 34610387RESULT

  • 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.

    PMID: 34903431RESULT

  • 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.

    PMID: 40921169DERIVED

Related Links

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

RadiotherapyBrachytherapyCisplatinCarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Carien L. Creutzberg, MD, PhD

    Leiden University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

December 11, 2006

First Posted

December 13, 2006

Study Start

November 23, 2006

Primary Completion

November 29, 2018

Study Completion

December 31, 2024

Last Updated

October 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Sharing of data will be an option after publication of long-term outcomes and after submission of a research plan with is approved by the with international TMG

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Anticipated in 218

Locations

NL(1)