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

This study has been completed.
Sponsor:
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005583
First received: May 2, 2000
Last updated: August 1, 2013
Last verified: November 2006

May 2, 2000
August 1, 2013
January 2000
Not Provided
  • Progression-free survival [ Designated as safety issue: No ]
  • Relapse-free survival [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00005583 on ClinicalTrials.gov Archive Site
Overall survival [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Endometrial Cancer
  • Drug: cisplatin
  • Drug: doxorubicin hydrochloride
  • Drug: epirubicin hydrochloride
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
July 2010
Not Provided

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Ireland,   Italy,   Netherlands,   Norway,   Poland,   Portugal,   South Africa,   Spain,   United Kingdom
 
NCT00005583
NSGO-EC9501, CDR0000067646, EORTC-55991
Not Provided
Not Provided
Nordic Society for Gynaecologic Oncology
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Gunnar B. Kristensen, MD, PhD Norwegian Radium Hospital
Investigator: Carlos F. de Oliveira, MD, PhD Hospitais da Universidade de Coimbra (HUC)
National Cancer Institute (NCI)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP