Endometrial CancerPhase 3NCT00002459
Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus
A Phase 3 study testing radiation therapy in people with Endometrial Cancer and Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 28 sites in 10 countries.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether receiving radiation therapy or no further therapy after surgery is more effective for cancer of the uterus. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer, Sarcoma
- What is being tested?
- radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 224 participants
- Where
- 28 sitesin 10 countries
- Study dates
- Apr 1988to Aug 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven high-grade uterine sarcoma Eligible subtypes: Leiomyosarcoma Mixed mesodermal (mullerian) sarcoma Endometrial sarcoma Surgically proven stage I or II (T1-2, N0, M0) disease No leiomyoma with a high mitotic activity index after hormonal therapy (especially estrogen) Mixoid leiomyosarcoma with a low mitotic activity index allowed Completely resected disease Prior abdominal hysterectomy as minimal surgical procedure required
PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix No serious mental disorder
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
Trial locations and contacts
28 sites in 10 countries.
28 sites in 10 countries
Netherlands9 sites
Vrije Universiteit Medisch Centrum
Amsterdam, 1001HV
Antoni van Leeuwenhoekhuis
Amsterdam, 1066 CX
Medisch Spectrum Twente
Enschede, 7500 KA
Atrium Medical Centre
Heerlen, 6419 PC
Academisch Ziekenhuis Maastricht
Maastricht, 6202 AZ
University Medical Center Nijmegen
Nijmegen, NL-6252 HB
University Hospital - Rotterdam Dijkzigt
Rotterdam, 3000 CA
Rotterdam Cancer Institute
Rotterdam, 3075 EA
Academisch Ziekenhuis Utrecht
Utrecht, 3508 GA
Italy8 sites
Spedali Civili
Brescia, 25124
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, 20133
Istituto Scientifico H.S. Raffaele
Milan, 20132
Ospedale San Gerardo
Monza, 20052
Universita di Padova
Padova, 35128
I.R.C.C.S. Policlinico San Matteo
Pavia, 27100
Ospedale di Circolo e Fondazione Macchi
Varese, 21100
Ospedale Civile
Voghera (PV), 27058
Canada2 sites
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Sweden2 sites
University Hospital of Linkoping
Linköping, S-581 85
Karolinska Hospital
Stockholm, S-171 76
United Kingdom2 sites
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
Switzerland1 site
Hopital Cantonal Universitaire de Geneva
Geneva, CH-1211
About this study
Official title: Phase III Randomized Study of Adjuvant Pelvic Radiotherapy Versus Observation Alone in Patients With Completely Resected, Stage I or II, High-Grade Uterine Sarcoma
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether receiving radiation therapy or no further therapy after surgery is more effective for cancer of the uterus.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of no further therapy in treating patients who have stage I or stage II cancer of the uterus that has been surgically removed.
Read the detailed description
OBJECTIVES: I. Compare the rates of pelvic recurrence and development of distant metastases in patients with completely resected, stage I or II, high-grade uterine sarcoma treated with adjuvant pelvic radiotherapy vs observation alone.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, tumor histology (leiomyosarcoma vs mixed mesodermal sarcoma vs endometrial stromal sarcoma), and surgical procedure (total abdominal hysterectomy (TAH) with or without bilateral salpingo-oophorectomy (BSO) vs TAH and BSO with pelvic and para-aortic node sampling and random biopsies). Patients are randomized to 1 of 2 treatment arms. Arm I: Beginning within 6 weeks after surgery, patients undergo pelvic radiotherapy 5 days a week for 5.6 weeks. Arm II: Patients undergo observation alone. Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 3 years.
- Conditions
- Endometrial Cancer, Sarcoma
- Being tested
- radiation therapy
- Keywords
- stage I uterine sarcoma, stage II uterine sarcoma, uterine carcinosarcoma, uterine leiomyosarcoma, endometrial stromal sarcoma
- Medical subject headings
- Endometrial Neoplasms, Sarcoma, Sarcoma, Endometrial Stromal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2004 (estimated)
- Study startApr 1988
- Primary completionAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- NCIC Clinical Trials Group
- Responsible party
- Sponsor
- Investigators
- Sergio L. Pecorelli, MD, Study chair, Spedali Civili di BresciaGavin C.E. Stuart, MD, Study chair, Tom Baker Cancer Centre - Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002459
- Sponsor's protocol ID
- EORTC-55874
- Other IDs
- EORTC-55874, CAN-NCIC-EN4
- Status last verified
- Sep 2012
- First submitted
- 1 Nov 1999
- Last updated
- 24 Sep 2012
- Results posted
- No
Publications
Reed NS, Mangioni C, Malmstrom H, Scarfone G, Poveda A, Pecorelli S, Tateo S, Franchi M, Jobsen JJ, Coens C, Teodorovic I, Vergote I, Vermorken JB; European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group. Phase III randomised study to evaluate the role of adjuvant pelvic radiotherapy in the treatment of uterine sarcomas stages I and II: an European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study (protocol 55874). Eur J Cancer. 2008 Apr;44(6):808-18. doi: 10.1016/j.ejca.2008.01.019. Epub 2008 Apr 2.
PubMed 18378136Reed NS, Mangioni C, Malmstrom H, et al.: First results of a randomised trial comparing radiotherapy versus observation post operatively in patients with uterine sarcomas. An EORTC-GCG study. [Abstract] Int J Gynecol Cancer 13 (Suppl 1): A-PL12, 4, 2003.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of Adjuvant Pelvic Radiotherapy Versus Observation Alone in Patients With Completely Resected, Stage I or II, High-Grade Uterine Sarcoma
- ClinicalTrials.gov ID
- NCT00002459
- Acronym / sponsor ID
- EORTC-55874
- Conditions
- Endometrial Cancer, Sarcoma
- Keywords
- stage I uterine sarcoma, stage II uterine sarcoma, uterine carcinosarcoma, uterine leiomyosarcoma, endometrial stromal sarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- NCIC Clinical Trials Group
- Study start
- Apr 1988
- Primary completion
- Aug 2001 (actual)
- First posted
- 11 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether receiving radiation therapy or no further therapy after surgery is more effective for cancer of the uterus.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of no further therapy in treating patients who have stage I or stage II cancer of the uterus that has been surgically removed.
Detailed description
OBJECTIVES: I. Compare the rates of pelvic recurrence and development of distant metastases in patients with completely resected, stage I or II, high-grade uterine sarcoma treated with adjuvant pelvic radiotherapy vs observation alone.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, tumor histology (leiomyosarcoma vs mixed mesodermal sarcoma vs endometrial stromal sarcoma), and surgical procedure (total abdominal hysterectomy (TAH) with or without bilateral salpingo-oophorectomy (BSO) vs TAH and BSO with pelvic and para-aortic node sampling and random biopsies). Patients are randomized to 1 of 2 treatment arms. Arm I: Beginning within 6 weeks after surgery, patients undergo pelvic radiotherapy 5 days a week for 5.6 weeks. Arm II: Patients undergo observation alone. Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
- Results publication: PubMed 18378136Reed NS, Mangioni C, Malmstrom H, Scarfone G, Poveda A, Pecorelli S, Tateo S, Franchi M, Jobsen JJ, Coens C, Teodorovic I, Vergote I, Vermorken JB; European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group. Phase III randomised study to evaluate the role of adjuvant pelvic radiotherapy in the treatment of uterine sarcomas stages I and II: an European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study (protocol 55874). Eur J Cancer. 2008 Apr;44(6):808-18. doi: 10.1016/j.ejca.2008.01.019. Epub 2008 Apr 2.
- Results publicationReed NS, Mangioni C, Malmstrom H, et al.: First results of a randomised trial comparing radiotherapy versus observation post operatively in patients with uterine sarcomas. An EORTC-GCG study. [Abstract] Int J Gynecol Cancer 13 (Suppl 1): A-PL12, 4, 2003.
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio L. Pecorelli, MD study chair
Spedali Civili di Brescia
Gavin C.E. Stuart, MD study chair
Tom Baker Cancer Centre - Calgary
28 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiation therapy in people with Endometrial Cancer and Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 28 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Netherlands, Italy, Canada, Sweden, United Kingdom and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002459, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.