Clinical trial NCT00006027: Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Treating Patients With Stage I or Stage II Endometrial Cancer
Official title: A Phase III Study of Adjuvant Postoperative Irradiation With or Without Cisplatin/Taxol Chemotherapy Following TAH/BSO for Patients With Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometrial Cancer
Keywords: stage I endometrial carcinoma
stage II endometrial carcinoma
endometrial adenocarcinoma
endometrial adenosquamous cell carcinoma
endometrial adenoacanthoma
endometrial clear cell carcinoma
endometrial papillary serous carcinoma
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Gynecologic Oncology Group
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without combination chemotherapy for endometrial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without combination chemotherapy following surgery in treating patients who have stage I or stage II endometrial cancer.

Detailed description: OBJECTIVES:

* Compare the relapse-free survival in patients with stage I or II endometrial cancer treated with adjuvant radiotherapy with or without cisplatin and paclitaxel after total abdominal hysterectomy and bilateral salpingo-oophorectomy.
* Compare the patterns of recurrence and the acute and late toxicity profiles associated with these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (IC-IIA vs IIB). Patients are randomized to one of two treatment arms.

* Arm I: Within 8 weeks after surgery, patients receive radiotherapy once daily 5 days a week for 5.5 weeks.
* Arm II: Within 8 weeks after surgery, patients receive radiotherapy as in arm I concurrently with cisplatin IV over 2-4 hours on days 1 and 28. After completion of radiotherapy, patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 2-4 hours on days 56, 84, 112, and 140.

Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 436 patients (218 per treatment arm) will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed uterine confined endometrioid endometrial adenocarcinoma with one of the following:

  * Grade 2 or 3 carcinoma with more than 50% myometrial invasion (stage IC and IIA)
  * Grade 2 or 3 carcinoma with stromal invasion of the cervix (stage IIB)
* No grade I adenocarcinoma
* Less than 50% papillary serous or clear cell histology on pathologic specimen
* Prior hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) and bilateral salpingo-oophorectomy with or without additional surgical staging for endometrial cancer no more than 8 weeks prior to study
* No known metastatic extrauterine metastases, known gross residual disease, positive peritoneal cytology, or distant metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Zubrod 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,800/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL

Hepatic:

* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal

Renal:

* Creatinine no greater than 1.5 mg/dL

Cardiovascular:

* No cardiac dysrhythmias

Other:

* No other malignancy within the past 5 years except nonmelanomatous skin cancer
* No medical contraindications to study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy

Surgery:

* See Disease Characteristics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: Los Gatos
country: United States
facility: Community Hospital of Los Gatos
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
state: California
city: Denver
country: United States
facility: University of Colorado Cancer Center at University of Colorado Health Sciences Center
state: Colorado
city: Honolulu
country: United States
facility: MBCCOP - Hawaii
state: Hawaii
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at University of Iowa
state: Iowa
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
state: Maryland
city: Boston
country: United States
facility: Tufts - New England Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center at University of Missouri - Columbia
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: State University of New York Health Science Center at Brooklyn
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Stony Brook
country: United States
facility: Long Island Cancer Center at Stony Brook University Hospital
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma College of Medicine
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Cancer Institute at Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Brookview Research, Inc.
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Tacoma
country: United States
facility: Tacoma General Hospital
state: Washington
city: Marshfield
country: United States
facility: CCOP - Marshfield Clinic Research Foundation
state: Wisconsin
city: Oslo
country: Norway
facility: Norwegian Radium Hospital
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kathryn M. Greven, MD
role: STUDY_CHAIR
affiliation: Memorial Sloan Kettering Cancer Center
name: Richard R. Barakat, MD
role: STUDY_CHAIR
References: