External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer - Full Text View

Purpose

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	Intervention	Phase
Endometrial Cancer	Radiation: External Beam Radiation Therapy Radiation: Vaginal Brachytherapy	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:

Rate of vaginal relapse [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of distant metastases [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Adverse effects [ Time Frame: 5 years ] [ Designated as safety issue: No ]
health-related quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Pelvic relapse [ Time Frame: 5 years ] [ Designated as safety issue: No ]


Enrollment:	427
Study Start Date:	May 2002
Study Completion Date:	April 2016
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	up to 120 Years (Child, Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of stage I endometrial cancer meeting 1 of the following criteria:
- Grade 1 or 2 with deep (≥ 50%) myometrial invasion (stage IC)
- Grade 2 or 3 with superficial (< 50%) myometrial invasion (stage IB)
No grade 3 endometrial carcinoma with deep myometrial invasion
Total abdominal hysterectomy and bilateral salpingo-oophorectomy required prior to randomization

PATIENT CHARACTERISTICS:

Menopausal status not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376844

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

Publications:

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.

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 EU-20508
Study First Received:	September 13, 2006
Last Updated:	April 24, 2016
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)
Individual Participant Data
Plan to Share IPD:	Undecided
Plan Description:	Will be decided late 2016

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2016

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