Brief Title
External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer
Official Title
PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy
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.
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 Phase
Phase 3
Study Type
Interventional
Primary Outcome
Vaginal relapse
Secondary Outcome
Rate of distant metastases
Condition
Endometrial Cancer
Intervention
External Beam Radiation Therapy
Study Arms / Comparison Groups
External Beam Radiation Therapy
Description: Postoperative pelvic radiotherapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
427
Start Date
May 2002
Completion Date
April 2016
Primary Completion Date
May 2009
Eligibility 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Carien L. Creutzberg, MD, PhD, ,
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT00376844
Organization ID
CDR0000502033
Secondary IDs
CKTO-2001-04
Responsible Party
Principal Investigator
Study Sponsor
Leiden University Medical Center
Collaborators
Dutch Cancer Society
Study Sponsor
Carien L. Creutzberg, MD, PhD, Study Chair, Leiden University Medical Center
Verification Date
February 2018