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

NCT00005583 | Completed Phase 3

• 3 other identifiers: NSGO-EC9501CDR0000067646EORTC-55991
• Study Type: interventional
• Target: 400
• Locations: 11 countries
• Sites: 23

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.

Conditions

Endometrial Cancer

Keywords

stage I endometrial carcinoma; stage II endometrial carcinoma; endometrial adenocarcinoma; endometrial papillary serous carcinoma; endometrial clear cell carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

• Relapse-free survival

Secondary Outcomes (1)

• Overall survival

Interventions

cisplatin DRUG

doxorubicin hydrochloride DRUG

epirubicin hydrochloride DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nordic Society of Gynaecological Oncology - Clinical Trials Unit: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator

Study Sites (23)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Cazk Groeninghe - Campus Maria's Voorzienigheid

Kortrijk, B-8500, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Coombe Women's Hospital

Dublin, 8, Ireland

Location

St. James's Hospital

Dublin, 8, Ireland

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, 80131, Italy

Location

Azienda Ospedaliera Di Parma

Parma, 43100, Italy

Location

Fondazione I.R.C.C.S. Policlinico San Matteo

Pavia, 27100, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Hospitais da Universidade de Coimbra (HUC)

Coimbra, 3049, Portugal

Location

Groote Schuur Hospital

Cape Town, 7925, South Africa

Location

Hospital Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33006, Spain

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Centre for Cancer Research and Cell Biology at Belfast City Hospital

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 20619634 BACKGROUND

• 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.

  RESULT

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Cisplatin; Doxorubicin; Epirubicin; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Gunnar B. Kristensen, MD, PhD

  Norwegian Radium Hospital

  STUDY CHAIR

• Carlos F. de Oliveira, MD, PhD

  Hospitais da Universidade de Coimbra (HUC)

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: January 27, 2003
• Study Start: January 1, 2000
• Study Completion: July 1, 2010
• Last Updated: August 2, 2013

Record last verified: 2006-11

Locations

ZA (1); IE (2); GB (3); PL (1); NL (3); PT (1); BE (4); FR (1); IT (4); ES (2); NO (1)