External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer (PORTEC-2)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

RATIONALE: External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving external-beam radiation therapy or implant radiation therapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether radiation therapy is more effective than observation when given after surgery in treating stage I endometrial cancer.

PURPOSE: This randomized phase III trial is studying external-beam radiation therapy or implant radiation therapy to see how well they work compared with observation in treating patients who have undergone surgery for stage I endometrial cancer.

Condition or disease	Intervention/treatment	Phase
Endometrial Cancer	Radiation: External Beam Radiation Therapy; Radiation: Vaginal Brachytherapy	Phase 3

Detailed Description:

OBJECTIVES:

• Compare the rate of 5-year locoregional relapse in patients undergoing external-beam radiotherapy or vaginal brachytherapy vs observation only after surgery for stage I endometrial cancer.
• Compare 5-year rate of distant metastases in these patients.
• Determine overall survival rate in these patients.
• Determine prognostic factors for relapse and morbidity.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo either vaginal brachytherapy or external-beam radiotherapy.
• Arm II: Patients are observed and undergo no further treatment. After completion of study treatment, patients are followed for approximately 83 days.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	427 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Exterbal beam radiation therapy versus vaginal brachytherapy
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy
Study Start Date :	May 2002
Actual Primary Completion Date :	May 2009
Actual Study Completion Date :	April 2016

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: External Beam Radiation Therapy; Postoperative pelvic radiotherapy	Radiation: External Beam Radiation Therapy; Other Name: pelvic radiotherapy
Experimental: Vaginal Brachytherapy; Postoperative vaginal brachytherapy	Radiation: Vaginal Brachytherapy; Other Name: internal radiation

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Vaginal relapse [ Time Frame: 5 years ]
   total vaginal relapse and vaginal relapse as first failure

Secondary Outcome Measures :

1. Rate of distant metastases [ Time Frame: 5 years ]
   total distant relapse and distant relapse as first failure
2. Overall survival [ Time Frame: 5 years ]
   all-cause survival (and cancer-related survival)
3. Adverse effects [ Time Frame: 5 years ]
   Types and severity graded according to EORTC-RTOG grading system
4. Health-related quality of life [ Time Frame: 5 years ]
   Cancer-specific quality of life (EORTC QLQ C-30); patient reported symptoms
5. Pelvic relapse [ Time Frame: 5 years ]
   total pelvic relapse and pelvic relapse as first failure

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

• Diagnosis of FIGO 1988 stage I-IIA endometrial cancer, meeting 1 of the following criteria:

  • Age ≥60, stage IC grade 1 or 2 with deep (≥ 50%) myometrial invasion
  • Age ≥60, stage IB grade 2 or 3 (with < 50% myometrial invasion)
  • Stage IIA, any age
• No grade 3 endometrial carcinoma with deep myometrial invasion
• Total abdominal hysterectomy and bilateral salpingo-oophorectomy required prior to randomisation
• WHO performance status 0-2

EXCLUSION CRITERIA:

• Serous or clear cell histology or uterine sarcoma
• staging lymphadenectomy
• interval between surgery and radiotherapy > 8 weeks
• history of previous malignant disease (except basal cell carcinoma of skin)
• previous radiotherapy, hormonal therapy or chemotherapy
• diagnosis of Chrohn's disease or ulcerative colitis

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300 RC

Sponsors and Collaborators

Leiden University Medical Center

Dutch Cancer Society

Investigators

Study Chair:	Carien L. Creutzberg, MD, PhD	Leiden University Medical Center

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ&#174; database 

Publications of Results:

Nout RA, Putter H, Jürgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Stenfert Kroese MC, Nijman HW, van de Poll-Franse LV, Creutzberg CL. Five-year quality of life of endometrial cancer patients treated in the randomised Post Operative Radiation Therapy in Endometrial Cancer (PORTEC-2) trial and comparison with norm data. Eur J Cancer. 2012 Jul;48(11):1638-48. doi: 10.1016/j.ejca.2011.11.014. Epub 2011 Dec 14.

Nout RA, Putter H, Jürgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Stenfert Kroese MC, van Bunningen BN, Smit VT, Nijman HW, van den Tol PP, Creutzberg CL. Quality of life after pelvic radiotherapy or vaginal brachytherapy for endometrial cancer: first results of the randomized PORTEC-2 trial. J Clin Oncol. 2009 Jul 20;27(21):3547-56. doi: 10.1200/JCO.2008.20.2424. Epub 2009 Jun 22.

Nout RA, Putter H, Jürgenliemk-Schulz IM, et al.: Vaginal brachytherapy versus external beam pelvic radiotherapy for high-intermediate risk endometrial cancer: Results of the randomized PORTEC-2 trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA5503, 2008.

Nout RA, Smit VT, Putter H, Jürgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Kroese MC, van Bunningen BN, Ansink AC, van Putten WL, Creutzberg CL; PORTEC Study Group. Vaginal brachytherapy versus pelvic external beam radiotherapy for patients with endometrial cancer of high-intermediate risk (PORTEC-2): an open-label, non-inferiority, randomised trial. Lancet. 2010 Mar 6;375(9717):816-23. doi: 10.1016/S0140-6736(09)62163-2.

de Boer SM, Nout RA, Jürgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Stenfert Kroese MC, Oerlemans S, Putter H, Verhoeven-Adema KW, Nijman HW, Creutzberg CL. Long-Term Impact of Endometrial Cancer Diagnosis and Treatment on Health-Related Quality of Life and Cancer Survivorship: Results From the Randomized PORTEC-2 Trial. Int J Radiat Oncol Biol Phys. 2015 Nov 15;93(4):797-809. doi: 10.1016/j.ijrobp.2015.08.023. Epub 2015 Aug 18.

Other Publications:

McCloskey SA, Tchabo NE, Malhotra HK, Odunsi K, Rodabaugh K, Singhal P, Lele S, Jaggernauth W. Adjuvant vaginal brachytherapy alone for high risk localized endometrial cancer as defined by the three major randomized trials of adjuvant pelvic radiation. Gynecol Oncol. 2010 Mar;116(3):404-7. doi: 10.1016/j.ygyno.2009.06.027. Epub 2009 Nov 27.

Responsible Party:	Carien Creutzberg, Professor of Radiation Oncology, Chief investigator, Leiden University Medical Center
ClinicalTrials.gov Identifier:	NCT00376844 History of Changes
Other Study ID Numbers:	CDR0000502033; CKTO-2001-04 ( Other Grant/Funding Number: Dutch Cancer Society ); P01.146 ( Other Identifier: LUMC Ethics Committee ); ISRCTN16228756 ( Registry Identifier: ISRCTN )
First Posted:	September 15, 2006
Last Update Posted:	February 27, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	Will be decided late 2016

Keywords provided by Carien Creutzberg, Leiden University Medical Center:

stage I endometrial carcinoma

Additional relevant MeSH terms:

Endometrial Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms	Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female