Trial | NCT00005583  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    doxorubicin epirubicin cisplatin ...

  • Study Participants

    400
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.
Study Started
Jan 31
2000
Study Completion
Jul 31
2010
Last Update
Aug 02
2013
Estimate

Drug cisplatin

Drug doxorubicin hydrochloride

Drug epirubicin hydrochloride

Procedure adjuvant therapy

Procedure conventional surgery

Radiation radiation therapy

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
No Results Posted