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


Phase 3
N/A
N/A
Open (Enrolling)
Female
Endometrial Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Gunnar B. Kristensen, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Norwegian Radium Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000067646

NCT ID:

NCT00005583

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • stage I endometrial carcinoma
  • stage II endometrial carcinoma
  • endometrial adenocarcinoma
  • endometrial papillary serous carcinoma
  • endometrial clear cell carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

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