Malignant Mixed Mesodermal Tumor (MMMT) - Early Stage With Postoperative XRT/Chemotherapy
- To test whether the addition of chemotherapy to radiotherapy improves the progression-free survival for patients with stage I, II and IIIa malignant mixed mesodermal tumor (MMMT) of the uterus.
- To determine the acute and late toxicity profiles associated with this treatment regimen.
- To describe the effect of this treatment regimen on the patient's quality of life.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Adjuvant Postoperative Radiation With Cisplatin Followed by Carboplatin/Paclitaxel Chemotherapy Following Total Abdominal Hysterectomy/Bilateral Salpino-Oophorectomy (TAH/BSO) for Patients With Stage I, II and IIIa Malignant Mixed Mesodermal Tumor (MMMT) of the Uterus.|
- Overall Survival [ Time Frame: 7 Years ] [ Designated as safety issue: No ]Survival defined as observed length of life from study entry until death or, for living patients, date of last contact.
|Study Start Date:||February 2002|
|Study Completion Date:||December 2010|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
Experimental: Radiation + Chemotherapy
Radiation with weekly Cisplatin 40 mg/m^2 intravenously (IV) Followed by Carboplatin (AUC 5 IV)/Paclitaxel (135 mg/m^2 IV) Chemotherapy every 28 days
AUC 5 by vein once every 28 Days
Other Name: paraplatinDrug: Cisplatin
40 mg/m^2 by vein (IV) Weekly Over 4 Hours
Other Names:Drug: Paclitaxel
135 mg/m^2 by vein (IV) Once Every 28 Days
Other Name: Taxol
Patients in this study will have an operation to remove their uterus, tubes, and ovaries with biopsies of the omentum and lymph nodes before entering this study.
Before treatment starts, patients will have a chest x-ray, computed tomography (CT) scan, blood tests, and a physical exam. Patients who have a history of hearing loss will have a hearing test.
Within 8 weeks after surgery, patients will receive 5 weeks of combination radiation therapy and cisplatin chemotherapy. Radiation and cisplatin will be given on Day 1 or day 2 of each week followed by 4 days of radiation alone. An additional dose of radiation, directed at the surface of the vagina, will be given either during the last week (Week 5) of treatment or after the radiation and cisplatin chemotherapy is finished.
Three to five weeks after radiation therapy and cisplatin chemotherapy is finished, patients will receive additional chemotherapy. Carboplatin and paclitaxel will be given every 28 days for 4 cycles. All chemotherapy is given into the vein through a catheter (tube).
Patients will be taken off study if their disease gets worse or intolerable side effects occur. Patients will be seen one month after the last cycle of chemotherapy, then every 3-4 months from then on for 2 years. At each visit, patients will have blood tests and a physical exam. Computed tomography (CT) scans will be ordered only if it is suspected that the disease has come back. All patients will be followed for a maximum of 2 years after their therapy is completed.
This is an investigational study. Cisplatin, Carboplatin and Paclitaxel are FDA approved and commercially available. A total of 49 patients will take part in this study. Up to 25 patients may be enrolled at M. D. Anderson Cancer Center in Houston, up to 12 patients will be enrolled at MD Anderson Cancer Center, Orlando, and up to 12 patients will be enrolled at the University of Texas Medical Branch in Galveston.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505492
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Washington|
|University of Washington School of Medicine|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Lois M. Ramondetta, MD||M.D. Anderson Cancer Center|