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

Endometrial Cancer Clinical Trial

Official title:

A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005583
• Other study ID #: NSGO-EC9501
• Secondary ID: CDR0000067646EOR
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2000
• Last updated: August 1, 2013
• Start date: January 2000
• Est. completion date: July 2010

Study information

• Verified date: November 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer

Intervention

Drug:
• cisplatin

• doxorubicin hydrochloride

• epirubicin hydrochloride

Procedure:
• adjuvant therapy

• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Cazk Groeninghe - Campus Maria's Voorzienigheid	Kortrijk
Belgium	U.Z. Gasthuisberg	Leuven
France	Centre Henri Becquerel	Rouen
Ireland	Coombe Women's Hospital	Dublin
Ireland	St. James's Hospital	Dublin
Italy	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
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Universitair Medisch Centrum St. Radboud - Nijmegen	Nijmegen
Norway	Norwegian Radium Hospital	Oslo
Poland	Medical University of Gdansk	Gdansk
Portugal	Hospitais da Universidade de Coimbra (HUC)	Coimbra
South Africa	Groote Schuur Hospital	Cape Town
Spain	Hospital Universitario San Carlos	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo
United Kingdom	Centre for Cancer Research and Cell Biology at Belfast City Hospital	Belfast	Northern Ireland
United Kingdom	Western Infirmary	Glasgow	Scotland
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England

Sponsors (2)

Lead Sponsor	Collaborator
Nordic Society for Gynaecologic Oncology	European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

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

References & Publications (2)

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,

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival			No
Primary	Relapse-free survival			No
Secondary	Overall survival			No