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

Endometrial Cancer Clinical Trial

— PORTEC-2  

Official title:

PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376844
• Other study ID #: CDR0000502033
• Secondary ID: CKTO-2001-04P01.
• Status: Completed
• Phase: Phase 3
• Start date: May 2002
• Est. completion date: April 2016

Study information

• Verified date: April 2022
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 427
• Est. completion date: April 2016
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Radiation:
• External Beam Radiation Therapy

• Vaginal Brachytherapy

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

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 Tre — View Citation

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. — View Citation

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, 200

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 random — View Citation

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 brach — View Citation

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 bea — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal relapse	total vaginal relapse and vaginal relapse as first failure	5 years
Secondary	Rate of distant metastases	total distant relapse and distant relapse as first failure	5 years
Secondary	Overall survival	all-cause survival (and cancer-related survival)	5 years
Secondary	Adverse effects	Types and severity graded according to EORTC-RTOG grading system	5 years
Secondary	Health-related quality of life	Cancer-specific quality of life (EORTC QLQ C-30); patient reported symptoms	5 years
Secondary	Pelvic relapse	total pelvic relapse and pelvic relapse as first failure	5 years

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database