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NCT00411138 · CITED IN SOURCE DOCUMENTS

Randomized Trial of Radiation Therapy With or Without Chemotherapy for Endometrial Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
UNKNOWN
Registry last update
2023-10-11

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically confirmed endometrial carcinoma, with one of the following postoperative FIGO 2009 stages and grade: 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: * 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
healthy Volunteers
false
maximum Age
90 Years
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Pelvic Radiotherapy alone
    intervention Names
    1. Radiation: Radiation Therapy
    label
    Radiation Therapy
    type
    ACTIVE_COMPARATOR
  2. description
    Pelvic Radiation plus 2 concurrent cycles cisplatin followed by 4 adjuvant cycles carboplatin and paclitaxel
    intervention Names
    1. Radiation: Radiation Therapy
    2. Drug: cisplatin
    3. Drug: carboplatin
    4. Drug: Paclitaxel
    label
    Radiation Therapy and Chemotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Radiation Therapy
    2. Radiation Therapy and Chemotherapy
    description
    External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions) Vaginal brachytherapy boost in case of cervical involvement
    name
    Radiation Therapy
    other Names
    1. RT
    2. 3D conformal radiotherapy
    3. IMRT
    4. brachytherapy
    type
    RADIATION
  2. arm Group Labels
    1. Radiation Therapy and Chemotherapy
    description
    cisplatin 50 mg/m2 i.v., 2 cycles during radiotherapy, 3 wks interval
    name
    cisplatin
    other Names
    1. Cisplatine
    type
    DRUG
  3. arm Group Labels
    1. Radiation Therapy and Chemotherapy
    description
    carboplatin AUC 5, 4 cycles after completion of radiotherapy, 3 wks interval
    name
    carboplatin
    other Names
    1. Carboplatine
    2. Carbotaxol
    type
    DRUG
  4. arm Group Labels
    1. Radiation Therapy and Chemotherapy
    description
    paclitaxel 175 mg/m2, 4 cycles after completion of radiotherapy, 3 wks interval
    name
    Paclitaxel
    other Names
    1. Taxol
    2. Taxolcarbo
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
670
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    co-primary endpoint
    measure
    Overall survival
    time Frame
    5 years
  2. description
    co-primary endpoint
    measure
    Failure-free survival
    time Frame
    5 years
secondary Outcomes
  1. description
    Health-related overall quality of life and patient-reported symptom measures
    measure
    Quality of life by QLQ-C30 v3.0
    time Frame
    5 years
  2. description
    Acute serious events and SAE and late grade 3-4 complications
    measure
    Severe treatment-related morbidity
    time Frame
    5 years
  3. description
    Both vaginal or pelvic relapse as first failure and total vaginal or pelvic relapse
    measure
    Vaginal or pelvic relapse
    time Frame
    5 years
  4. description
    Both distant relapse as first failure and total distant relapse
    measure
    Distant metastases
    time Frame
    5 years
Full study description
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.
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 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.
Source references
references
  1. citation
    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
    27059658
    type
    BACKGROUND
  2. citation
    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
    27764842
    type
    BACKGROUND
  3. citation
    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
    29190319
    type
    RESULT
  4. citation
    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
    27397040
    type
    RESULT
  5. citation
    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
    29449189
    type
    RESULT
  6. citation
    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
    31345626
    type
    RESULT
  7. citation
    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
    33129910
    type
    RESULT
  8. citation
    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
    32749941
    type
    RESULT
  9. citation
    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
    33693762
    type
    RESULT
  10. citation
    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
    34610387
    type
    RESULT
  11. citation
    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
    34903431
    type
    RESULT
  12. citation
    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
    40921169
    type
    DERIVED
Source notices and limitations
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        1 and 2 with &gt;50% myometrial invasion or grade 3 with &lt;50% myometrial invasion).[<a href="#cit/section_5.33">33</a>]</li><li>The <a href="/clinicaltrials/NCT00411138">PORTEC-2</a> trial (NCT00411138) randomly assigned patients with stage I endometrial cancer who did not undergo lymph node dissection to undergo VBT or EBRT,
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        nvasion or grade 3 with &lt;50% myometrial invasion).[<a href="#cit/section_5.33">33</a>]</li><li>The <a href="/clinicaltrials/NCT00411138">PORTEC-2</a> trial (NCT00411138) randomly assigned patients with stage I endometrial cancer who did not undergo lymph node dissection to undergo VBT or EBRT, with prevention of vaginal recurr
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      source update dates
      1. context
        Updated: May 14, 2025
        datetime
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        display
        May 14, 2025

    Preserved source evidence · Not medical advice