Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Condition: Endometrial Adenocarcinoma; Endometrial Adenosquamous Carcinoma; Endometrial Clear Cell Adenocarcinoma; Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation; Endometrial Serous Adenocarcinoma; Stage III Uterine Corpus Cancer
MeSH terms: Carcinoma; Adenocarcinoma; Cystadenocarcinoma, Serous; Carcinoma, Endometrioid; Adenocarcinoma, Clear Cell; Carcinoma, Adenosquamous
Intervention: Doxorubicin Hydrochloride; Cisplatin; Filgrastim; Pegfilgrastim; Paclitaxel
Intervention description: Given IV; Given IV; Given SC; Given SC; Given IV
Intervention MeSH terms: Paclitaxel; Doxorubicin; Liposomal doxorubicin; Lenograstim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 659.0
Sex: Female
Healthy volunteers: No

Summary:

      Randomized phase III trial to compare the effectiveness of two combination chemotherapy
      regimens plus radiation therapy in treating patients who have stage III or stage IV
      endometrial cancer. 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. Combining more than one chemotherapy drug with radiation therapy may kill
      more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation
      therapy is more effective for endometrial cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed advanced endometrial carcinoma with any histology, including:

               -  Clear cell and serous papillary carcinoma

          -  Surgical stage III disease, including:

               -  Positive adnexa

               -  Tumor invading the serosa

               -  Positive pelvic and/or paraaortic nodes

               -  Involvement of bowel mucosa

               -  Intraabdominal metastases

               -  Positive pelvic washings

               -  Vaginal involvement within the radiation port

          -  Must have had prior surgery, including hysterectomy and bilateral
             salpingo-oophorectomy

               -  Tumor maximally debulked to a maximum residual diameter of no greater than 2 cm

               -  Paraaortic lymph node sampling allowed

                    -  If positive, must have negative chest CT scan

          -  No recurrent disease

          -  No parenchymal liver metastases

          -  No disease outside the abdomen

          -  Performance status - GOG 0-2

          -  At least 3 months

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Bilirubin no greater than 1.5 times normal

          -  SGOT/SGPT no greater than 3 times normal

          -  Alkaline phosphatase no greater than 3 times normal

          -  Creatinine no greater than 1.6 mg/dL

          -  LVEF at least 50% within 6 months of study entry

          -  No other prior or concurrent malignancy within the past 5 years except adequately
             treated nonmelanoma skin cancer

          -  No serious comorbid illness that would preclude study participation

          -  No prior chemotherapy

          -  See Disease Characteristics

          -  No prior pelvic or abdominal radiotherapy

          -  No prior radiotherapy for prior malignancy

          -  See Disease Characteristics