Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometria… (NCT01672892) | Clinical Trial Compass
CompletedPhase 3
Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer
United States289 participantsStarted 2012-11
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial and cervical cancer after surgery.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Pathologically proven diagnosis of endometrial or cervical cancer.
✓. Patients must have undergone a hysterectomy (total abdominal hysterectomy, vaginal hysterectomy or radical hysterectomy or total laparoscopic hysterectomy) for carcinoma of the cervix or endometrium within 49 days prior to registration. Performance of a bilateral salpingooophorectomy will be at the treating surgeon's discretion.
✓. Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
✓. Zubrod Performance Status 0-2
✓. Age ≥ 18;
✓. Complete blood count (CBC)/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows:
✓. For patients receiving chemotherapy:
✓.1 Within 14 days prior to registration, serum creatinine ≤ 1.5 mg/dL and calculated creatinine clearance ≥ 50 cc/min. Both tests must be within these limits. The creatinine clearance should be calculated using the Cockcroft-Gault formula: (See Section 7.3.1) 7.2 Aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN) 7.3 Bilirubin ≤ 2 x ULN 7.4 Alkaline phosphatase, Mg, blood urea nitrogen (BUN) and electrolytes must be obtained and recorded 8 Endometrial Cancer: 8.1 Patients with the following histologic features are eligible for pelvic radiation therapy without weekly cisplatin:
Exclusion criteria
✕. Patients with para-aortic nodal disease or who require extended field radiotherapy beyond the pelvis.
What they're measuring
1
Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation
✕. Patients with histology consisting of endometrial stromal sarcoma, leiomyosarcoma or malignant mixed mullerian mixed tumor (MMMT or carcinosarcoma)
✕. Patients who exceed the weight/size limits of the treatment table or CT scanner.
✕. Mental status changes or bladder control problems that make the patient unable to comply with bladder-filling instructions.
✕. Patients with evidence of metastatic disease outside of the pelvis.
✕. Patients with positive or close (\< 3 mm) resection margins
✕. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.