Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Nordic Society for Gynaecologic Oncology
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: April 30, 2011
Last verified: November 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma |
Resource links provided by NLM:
Drug Information available for:
Cisplatin
Doxorubicin
Doxorubicin hydrochloride
Epirubicin hydrochloride
Epirubicin
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Progression-free survival [ Designated as safety issue: No ]
- Relapse-free survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | January 2000 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005583
Locations
| Belgium | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Cazk Groeninghe - Campus Maria's Voorzienigheid | |
| Kortrijk, Belgium, B-8500 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| France | |
| Centre Henri Becquerel | |
| Rouen, France, 76038 | |
| Ireland | |
| Coombe Women's Hospital | |
| Dublin, Ireland, 8 | |
| St. James's Hospital | |
| Dublin, Ireland, 8 | |
| Italy | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |
| Naples, Italy, 80131 | |
| Azienda Ospedaliera Di Parma | |
| Parma, Italy, 43100 | |
| Fondazione I.R.C.C.S. Policlinico San Matteo | |
| Pavia, Italy, 27100 | |
| Ospedale di Circolo e Fondazione Macchi | |
| Varese, Italy, 21100 | |
| Netherlands | |
| Onze Lieve Vrouwe Gasthuis | |
| Amsterdam, Netherlands, 1091 HA | |
| Medisch Spectrum Twente | |
| Enschede, Netherlands, 7500 KA | |
| Universitair Medisch Centrum St. Radboud - Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Norway | |
| Norwegian Radium Hospital | |
| Oslo, Norway, N-0310 | |
| Poland | |
| Medical University of Gdansk | |
| Gdansk, Poland, 80-211 | |
| Portugal | |
| Hospitais da Universidade de Coimbra (HUC) | |
| Coimbra, Portugal, 3049 | |
| South Africa | |
| Groote Schuur Hospital | |
| Cape Town, South Africa, 7925 | |
| Spain | |
| Hospital Universitario San Carlos | |
| Madrid, Spain, 28040 | |
| Hospital Universitario Central de Asturias | |
| Oviedo, Spain, 33006 | |
| United Kingdom | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Centre for Cancer Research and Cell Biology at Belfast City Hospital | |
| Belfast, Northern Ireland, United Kingdom, BT9 7AB | |
| Western Infirmary | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
Sponsors and Collaborators
Nordic Society for Gynaecologic Oncology
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Study Chair: | Gunnar B. Kristensen, MD, PhD | Norwegian Radium Hospital |
| Investigator: | Carlos F. de Oliveira, MD, PhD | Hospitais da Universidade de Coimbra (HUC) |
More Information
Additional Information:
Publications:
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.
| ClinicalTrials.gov Identifier: | NCT00005583 History of Changes |
| Other Study ID Numbers: | CDR0000067646, NSGO-EC9501, EORTC-55991 |
| Study First Received: | May 2, 2000 |
| Last Updated: | April 30, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I endometrial carcinoma stage II endometrial carcinoma endometrial adenocarcinoma endometrial papillary serous carcinoma endometrial clear cell carcinoma |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue |
Endometrial Stromal Tumors Neoplasms, Glandular and Epithelial Adjuvants, Immunologic Cisplatin Doxorubicin Epirubicin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on May 19, 2013