Endometrial CancerPhase 3NCT00005583
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
A Phase 3 study testing cisplatin, doxorubicin hydrochloride and epirubicin hydrochloride in people with Endometrial Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 23 sites in 11 countries.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- cisplatin, doxorubicin hydrochloride and epirubicin hydrochloride
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 23 sitesin 11 countries
- Study dates
- Jan 2000to Jul 2010
- 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 confirmed endometrial cancer of 1 of the following types:
- Clear cell carcinoma
- Serous papillary carcinoma
- Undifferentiated (anaplastic) carcinoma
- Poorly differentiated (FIGO grade 3) adenocarcinoma with infiltration to more than half the myometrial thickness
- No small cell carcinoma with neuroendocrine differentiation
- Primary in FIGO surgical stage I or occult stage II
- No spread of disease outside the uterine corpus except to pelvic lymph nodes
- No spread of disease to para-aortic lymph nodes
- Positive peritoneal washings allowed
- No preoperative macroscopic tumor involvement of the cervix
- Microscopic tumor involvement of the cervix on histopathological evaluation of the operative uterine specimen allowed
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Adequate bone marrow function
- WBC at least 3,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Adequate hepatic function
Renal:
- Adequate renal function
- Creatinine no greater than 1.4 mg/dL
Pulmonary:
- Adequate pulmonary function
Other:
- Not pregnant or nursing
- Fit to receive combination chemotherapy
- No other malignancy except basal cell or squamous cell skin cancer
- No uncontrolled or potentially active site of infection (e.g., fistula or abscesses)
- No other concurrent condition that would produce a substantial increase in risk for complications from radiotherapy
- No other concurrent condition that would interfere with adequate follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior preoperative irradiation
Surgery:
- No prior extensive abdominal surgery
Trial locations and contacts
23 sites in 11 countries.
23 sites in 11 countries
Belgium4 sites
Institut Jules Bordet
Brussels, 1000
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, B-8500
U.Z. Gasthuisberg
Leuven, B-3000
Italy4 sites
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, 80131
Azienda Ospedaliera Di Parma
Parma, 43100
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, 27100
Ospedale di Circolo e Fondazione Macchi
Varese, 21100
Netherlands3 sites
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 HA
Medisch Spectrum Twente
Enschede, 7500 KA
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, NL-6500 HB
United Kingdom3 sites
Centre for Cancer Research and Cell Biology at Belfast City Hospital
Belfast, Northern Ireland, BT9 7AB
Western Infirmary
Glasgow, Scotland, G11 6NT
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
Ireland2 sites
Coombe Women's Hospital
Dublin, 8
St. James's Hospital
Dublin, 8
Spain2 sites
Hospital Universitario San Carlos
Madrid, 28040
Hospital Universitario Central de Asturias
Oviedo, 33006
About this study
Official title: A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy with chemotherapy is more effective than radiation therapy alone in treating high-risk endometrial cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy and chemotherapy to see how well they work compared to radiation therapy alone in treating patients with high-risk endometrial cancer.
Read the detailed description
OBJECTIVES:
- Compare relapse-free survival of patients with high-risk endometrial carcinoma treated in the adjuvant setting with either radiotherapy alone or radiotherapy and chemotherapy given sequentially.
- Compare overall survival of this patient population treated with these 2 adjuvant regimens.
- Evaluate the addition of chemotherapy to standard adjuvant radiotherapy, in terms of toxicity, in these patients.
- Study whether the pattern of relapse in these patients is influenced by the addition of chemotherapy to adjuvant radiotherapy.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to center and histologic type (serous papillary and clear cell vs all other types). Patients are randomized to 1 of 2 treatment arms.
All patients undergo hysterectomy with bilateral salpingooophorectomy and extirpation of macroscopic suspicious lymph nodes.
- Arm I: Within 7 weeks after surgery, patients begin radiotherapy.
- Arm II: Patients receive radiotherapy followed by or preceded by chemotherapy*. Patients receive cisplatin IV over 60 minutes and doxorubicin or epirubicin IV over 10-20 minutes on day 1. Treament repeats every 21 days for 4 courses.
NOTE: *If radiotherapy is preceded by chemotherapy, radiotherapy begins within 4 weeks after chemotherapy.
Patients are followed at 3 and 6 months and then every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 5 years.
- Conditions
- Endometrial Cancer
- Being tested
- cisplatin, doxorubicin hydrochloride, epirubicin hydrochloride, adjuvant therapy, conventional surgery
- Keywords
- stage I endometrial carcinoma, stage II endometrial carcinoma, endometrial adenocarcinoma, endometrial papillary serous carcinoma, endometrial clear cell carcinoma
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
epirubicin hydrochlorideDrug
adjuvant therapyProcedure or surgery
conventional surgeryProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Relapse-free survival
Secondary outcomes (1)
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2000
- Study completionJul 2010
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.
- 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
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials Unit
- Sponsor type
- University, hospital or other
- Investigators
- Gunnar B. Kristensen, MD, PhD, Study chair, Norwegian Radium HospitalCarlos F. de Oliveira, MD, PhD, Hospitais da Universidade de Coimbra (HUC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005583
- Sponsor's protocol ID
- NSGO-EC9501
- Other IDs
- CDR0000067646, EORTC-55991
- Status last verified
- Nov 2006
- First submitted
- 2 May 2000
- Last updated
- 2 Aug 2013
- Results posted
- No
Publications
Hogberg T, Signorelli M, de Oliveira CF, Fossati R, Lissoni AA, Sorbe B, Andersson H, Grenman S, Lundgren C, Rosenberg P, Boman K, Tholander B, Scambia G, Reed N, Cormio G, Tognon G, Clarke J, Sawicki T, Zola P, Kristensen G. Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer--results from two randomised studies. Eur J Cancer. 2010 Sep;46(13):2422-31. doi: 10.1016/j.ejca.2010.06.002. Epub 2010 Jul 7.
PubMed 20619634Hogberg T, Rosenberg P, Kristensen G, et al.: A randomized phase-III study on adjuvant treatment with radiation (RT) ± chemotherapy (CT) in early-stage high-risk endometrial cancer (NSGO-EC-9501/EORTC 55991). [Abstract] J Clin Oncol 25 (Suppl 18): A-5503, 274s, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT00005583
- Acronym / sponsor ID
- NSGO-EC9501
- Conditions
- Endometrial Cancer
- Keywords
- stage I endometrial carcinoma, stage II endometrial carcinoma, endometrial adenocarcinoma, endometrial papillary serous carcinoma, endometrial clear cell carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials UnitUniversity, hospital or other
- Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC
- Study start
- Jan 2000
- Study completion
- Jul 2010 (actual)
- First posted
- 27 Jan 2003 (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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy with chemotherapy is more effective than radiation therapy alone in treating high-risk endometrial cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy and chemotherapy to see how well they work compared to radiation therapy alone in treating patients with high-risk endometrial cancer.
Detailed description
OBJECTIVES:
- Compare relapse-free survival of patients with high-risk endometrial carcinoma treated in the adjuvant setting with either radiotherapy alone or radiotherapy and chemotherapy given sequentially.
- Compare overall survival of this patient population treated with these 2 adjuvant regimens.
- Evaluate the addition of chemotherapy to standard adjuvant radiotherapy, in terms of toxicity, in these patients.
- Study whether the pattern of relapse in these patients is influenced by the addition of chemotherapy to adjuvant radiotherapy.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to center and histologic type (serous papillary and clear cell vs all other types). Patients are randomized to 1 of 2 treatment arms.
All patients undergo hysterectomy with bilateral salpingooophorectomy and extirpation of macroscopic suspicious lymph nodes.
- Arm I: Within 7 weeks after surgery, patients begin radiotherapy.
- Arm II: Patients receive radiotherapy followed by or preceded by chemotherapy*. Patients receive cisplatin IV over 60 minutes and doxorubicin or epirubicin IV over 10-20 minutes on day 1. Treament repeats every 21 days for 4 courses.
NOTE: *If radiotherapy is preceded by chemotherapy, radiotherapy begins within 4 weeks after chemotherapy.
Patients are followed at 3 and 6 months and then every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
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 |
|---|---|---|
| cisplatin | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| epirubicin hydrochloride | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Progression-free survival
Relapse-free survival
1 secondary outcome
Overall survival
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 2 Aug 2013.
- Background: PubMed 20619634Hogberg T, Signorelli M, de Oliveira CF, Fossati R, Lissoni AA, Sorbe B, Andersson H, Grenman S, Lundgren C, Rosenberg P, Boman K, Tholander B, Scambia G, Reed N, Cormio G, Tognon G, Clarke J, Sawicki T, Zola P, Kristensen G. Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer--results from two randomised studies. Eur J Cancer. 2010 Sep;46(13):2422-31. doi: 10.1016/j.ejca.2010.06.002. Epub 2010 Jul 7.
- Results publicationHogberg T, Rosenberg P, Kristensen G, et al.: A randomized phase-III study on adjuvant treatment with radiation (RT) ± chemotherapy (CT) in early-stage high-risk endometrial cancer (NSGO-EC-9501/EORTC 55991). [Abstract] J Clin Oncol 25 (Suppl 18): A-5503, 274s, 2007.
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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.
Gunnar B. Kristensen, MD, PhD study chair
Norwegian Radium Hospital
Carlos F. de Oliveira, MD, PhD
Hospitais da Universidade de Coimbra (HUC)
23 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cisplatin, doxorubicin hydrochloride and epirubicin hydrochloride in people with Endometrial Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 23 sites in 11 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 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Belgium, Italy, Netherlands, United Kingdom, Ireland and 6 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.
What does the primary outcome measure?
Progression-free survival. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005583, 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 2 Aug 2013.