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Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cisplatin
doxorubicin hydrochloride
epirubicin hydrochloride
adjuvant therapy
conventional surgery
radiation therapy
Sponsored by
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring stage I endometrial carcinoma, stage II endometrial carcinoma, endometrial adenocarcinoma, endometrial papillary serous carcinoma, endometrial clear cell carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Jules Bordet
  • Universitair Ziekenhuis Antwerpen
  • Cazk Groeninghe - Campus Maria's Voorzienigheid
  • U.Z. Gasthuisberg
  • Centre Henri Becquerel
  • Coombe Women's Hospital
  • St. James's Hospital
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • Azienda Ospedaliera Di Parma
  • Fondazione I.R.C.C.S. Policlinico San Matteo
  • Ospedale di Circolo e Fondazione Macchi
  • Onze Lieve Vrouwe Gasthuis
  • Medisch Spectrum Twente
  • Universitair Medisch Centrum St. Radboud - Nijmegen
  • Norwegian Radium Hospital
  • Medical University of Gdansk
  • Hospitais da Universidade de Coimbra (HUC)
  • Groote Schuur Hospital
  • Hospital Universitario San Carlos
  • Hospital Universitario Central de Asturias
  • Nottingham City Hospital NHS Trust
  • Centre for Cancer Research and Cell Biology at Belfast City Hospital
  • Western Infirmary

Outcomes

Primary Outcome Measures

Progression-free survival
Relapse-free survival

Secondary Outcome Measures

Overall survival

Full Information

First Posted
May 2, 2000
Last Updated
August 1, 2013
Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00005583
Brief Title
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
Official Title
A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
stage I endometrial carcinoma, stage II endometrial carcinoma, endometrial adenocarcinoma, endometrial papillary serous carcinoma, endometrial clear cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Progression-free survival
Title
Relapse-free survival
Secondary Outcome Measure Information:
Title
Overall survival

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar B. Kristensen, MD, PhD
Organizational Affiliation
Norwegian Radium Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlos F. de Oliveira, MD, PhD
Organizational Affiliation
Hospitais da Universidade de Coimbra (HUC)
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Cazk Groeninghe - Campus Maria's Voorzienigheid
City
Kortrijk
ZIP/Postal Code
B-8500
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Coombe Women's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
St. James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera Di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Fondazione I.R.C.C.S. Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 HA
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7500 KA
Country
Netherlands
Facility Name
Universitair Medisch Centrum St. Radboud - Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway
Facility Name
Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Hospitais da Universidade de Coimbra (HUC)
City
Coimbra
ZIP/Postal Code
3049
Country
Portugal
Facility Name
Groote Schuur Hospital
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Hospital Universitario San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Centre for Cancer Research and Cell Biology at Belfast City Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Western Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20619634
Citation
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.
Results Reference
background
Citation
Hogberg 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.
Results Reference
result

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Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer

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