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

NCT ID: NCT00005583

Last Updated: 2013-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2010-07-31

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.

Conditions

Endometrial Cancer

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cisplatin

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

epirubicin hydrochloride

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

conventional surgery

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: collaborator

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

OTHER

Sponsor Role: lead

Principal Investigators

Gunnar B. Kristensen, MD, PhD

Role: STUDY_CHAIR

Norwegian Radium Hospital

Carlos F. de Oliveira, MD, PhD

Role:

Hospitais da Universidade de Coimbra (HUC)

Locations

Institut Jules Bordet

Brussels, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Cazk Groeninghe - Campus Maria's Voorzienigheid

Kortrijk, , Belgium

U.Z. Gasthuisberg

Leuven, , Belgium

Centre Henri Becquerel

Rouen, , France

Coombe Women's Hospital

Dublin, , Ireland

St. James's Hospital

Dublin, , Ireland

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, , Italy

Azienda Ospedaliera Di Parma

Parma, , Italy

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

Pavia, , Italy

Ospedale di Circolo e Fondazione Macchi

Varese, , Italy

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Medisch Spectrum Twente

Enschede, , Netherlands

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, , Netherlands

Norwegian Radium Hospital

Oslo, , Norway

Medical University of Gdansk

Gdansk, , Poland

Hospitais da Universidade de Coimbra (HUC)

Coimbra, , Portugal

Groote Schuur Hospital

Cape Town, , South Africa

Hospital Universitario San Carlos

Madrid, , Spain

Hospital Universitario Central de Asturias

Oviedo, , Spain

Nottingham City Hospital NHS Trust

Nottingham, England, United Kingdom

Centre for Cancer Research and Cell Biology at Belfast City Hospital

Belfast, Northern Ireland, United Kingdom

Western Infirmary

Glasgow, Scotland, United Kingdom

Countries

Belgium; France; Ireland; Italy; Netherlands; Norway; Poland; Portugal; South Africa; Spain; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 20619634 (View on PubMed)

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.

Reference Type: RESULT

Other Identifiers

CDR0000067646

Identifier Type: REGISTRY

Identifier Source: secondary_id

EORTC-55991

Identifier Type: -

Identifier Source: secondary_id

NSGO-EC9501

Identifier Type: -

Identifier Source: org_study_id