A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma
A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma
RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy (IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with or without chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to the pelvis with or without chemotherapy works in treating patients with endometrial cancer or cervical cancer that has been removed by surgery.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (cervical vs endometrial cancer).
All patients undergo intensity modulated radiotherapy (IMRT) once a day, 5 days a week, for 5.5 weeks. Patients with cervical cancer also receive cisplatin IV over 30-60 minutes on day 1 or 2. Treatment with cisplatin repeats every 7 days for 5 courses (during radiotherapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6 weeks post-IMRT and then every 3 months for 2 years, every 6 months for years 3-5, and then annually for at least 3 years.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Must have undergone a hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal) within 7 weeks prior to study entry
Histologically confirmed diagnosis of 1 of the following:
Endometrial cancer meeting 1 of the following criteria:
Stage IB grade 3, IC grade 1-3, IIA, or IIB disease requiring postoperative pelvic radiotherapy
Unstaged (no lymph node dissection or sampling) stage IB grade 2 disease
Stage IIIC with all of the following:
Cervical cancer meeting 1 of the following criteria:
Post-radical hysterectomy and requires postoperative pelvic radiotherapy due to any of the following:
Positive pelvic nodes (negative para-aortic nodes)
Microscopic parametrial involvement and negative margins
Disease qualified by Sedlis criteria must have 2 of the following risk factors:
Post-simple hysterectomy with negative margins and negative nodes by CT scan, MRI, or positron emission tomography-CT scan
No requirement for extended-field radiotherapy beyond the pelvis
No histologically confirmed papillary serous, clear cell, or neuroendocrine (either large or small cell) disease, endometrial stromal sarcoma, leiomyosarcoma, or malignant müllerian mixed tumor
No evidence of metastatic disease outside of the pelvis
No microscopic involvement of the resection margin (< 3 mm)
PATIENT CHARACTERISTICS:
Zubrod performance status 0-2
WBC (white blood cell count) ≥ 4,000/mm³ (cervical cancer patients only)
Absolute neutrophil count ≥ 1,800/mm³ (cervical cancer patients only)
Platelet count ≥ 100,000/mm³ (cervical cancer patients only)
Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
Serum creatinine ≤ 2.0 mg/dL (cervical cancer patients only)
Creatinine clearance ≥ 50 mL/min (cervical cancer patients only)
AST (aspartate aminotransferase) ≤ 2 times upper limit of normal
Bilirubin ≤ 2 times upper limit of normal
Patients must not exceed the weight and size limits of the treatment table or CT scanner
No active inflammatory bowel disease
No severe, active, concurrent illness, defined as any of the following:
No history of allergy to cisplatin (cervical cancer patients)
No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for ≥ 3 years
PRIOR CONCURRENT THERAPY:
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