Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus
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|ClinicalTrials.gov Identifier: NCT00002546|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 11, 2016
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RATIONALE: 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. It is not yet known whether radiation therapy is more effective than combination chemotherapy in treating patients with cancer of the uterus.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to combination chemotherapy in treating patients with cancer of the uterus.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: cisplatin Drug: ifosfamide Procedure: adjuvant therapy Radiation: radiation therapy||Phase 3|
- Compare the survival, progression-free interval, and failure patterns in patients with optimally debulked stage I-IV carcinosarcoma of the uterus treated with whole abdominal radiotherapy vs ifosfamide and cisplatin.
- Compare the incidence and type of acute and late adverse events observed with these treatment regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive whole abdominal radiotherapy 5 days a week for 4 weeks, followed by radiotherapy boost to the pelvis 5 days a week for 2.2 weeks.
- Arm II: Patients receive cisplatin IV followed by ifosfamide IV over 1 hour on days 1-4. Treatment continues every 3 weeks for 3 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 6 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||216 participants|
|Official Title:||A Phase III Randomized Study of Accelerated Hyperfractionated Whole Abdominal Radiotherapy (AHWAR) Versus Combination Ifosfamide-Mesna With Cisplatin in Optimally Debulked Stage I, II, III, or IV Carcinosarcoma (CS) of The Uterus|
|Study Start Date :||December 1993|
|Actual Primary Completion Date :||September 2007|
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|Ages Eligible for Study:||21 Years to 120 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Histologically confirmed primary homologous or heterologous carcinosarcoma of the uterus (corpus and cervix)
- Surgical stage I-IV disease, including positive adnexa, tumor invading the serosa, positive pelvic and/or para-aortic nodes, involvement of the mucosa of the bowel, bladder, or rectum, intra-abdominal metastases, positive pelvic washings, or vaginal involvement within planned radiation port
Prior total abdominal hysterectomy with bilateral salpingo-oophorectomy and maximum tumor resection of all gross intra-abdominal/pelvic disease, including grossly involved pelvic and para-aortic nodes within 8 weeks before study
- No greater than 1 cm residual disease
- Cervical sarcomas also allowed
No metastasis beyond the abdominal cavity at diagnosis, including the following:
- Parenchymal liver metastasis
- Lung metastasis
- Positive inguinal lymph nodes
- Positive scalene nodes
- Radiographic or pathologic evidence of bone or brain metastasis
- 21 and over
- GOG 0-2
- WBC at least 3,000/mm3
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 3 times normal
- Albumin at least 3 g/dL
- No acute hepatitis
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 50 mL/min
- No septicemia
- No severe infection
- No severe gastrointestinal bleeding
- No prior invasive or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
- Not specified
- No prior chemotherapy
- Prior hormonal therapy allowed
- See Disease Characteristics
- No prior radiotherapy
- See Disease Characteristics
- No prior therapy that would preclude study therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002546
|Study Chair:||Aaron H. Wolfson, MD||University of Miami Sylvester Comprehensive Cancer Center|
|Study Chair:||Higinia R. Cardenes, MD, PhD||Indiana University Melvin and Bren Simon Cancer Center|
|Other Study ID Numbers:||
CDR0000063303 ( Other Identifier: NIH )
NCI-2012-02226 ( Other Identifier: NCI )
|First Posted:||January 27, 2003 Key Record Dates|
|Last Update Posted:||February 11, 2016|
|Last Verified:||February 2016|
stage I uterine sarcoma
stage II uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action