TriangleNCT00002546 · CITED IN SOURCE DOCUMENTS
Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2016-02-11
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age: * 21 and over Performance status: * GOG 0-2 Hematopoietic: * WBC at least 3,000/mm3 * Granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 1.5 times normal * SGOT no greater than 3 times normal * Albumin at least 3 g/dL * No acute hepatitis Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 50 mL/min Other: * 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: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior hormonal therapy allowed Radiotherapy: * See Disease Characteristics * No prior radiotherapy Surgery: * See Disease Characteristics Other: * No prior therapy that would preclude study therapy
- healthy Volunteers
- false
- maximum Age
- 120 Years
- minimum Age
- 21 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- interventions
- name
- cisplatin
- type
- DRUG
- name
- ifosfamide
- type
- DRUG
- name
- adjuvant therapy
- type
- PROCEDURE
- name
- radiation therapy
- type
- RADIATION
Study design
- allocation
- RANDOMIZED
- primary Purpose
- TREATMENT
Enrollment
- count
- 216
- type
- ESTIMATED
Registered outcome plans (not posted results)
Full study description
- brief Summary
- 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.
- detailed Description
- OBJECTIVES: * 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.
Source references
- references
- citation
- Wolfson AH, Brady MF, Rocereto T, Mannel RS, Lee YC, Futoran RJ, Cohn DE, Ioffe OB. A gynecologic oncology group randomized phase III trial of whole abdominal irradiation (WAI) vs. cisplatin-ifosfamide and mesna (CIM) as post-surgical therapy in stage I-IV carcinosarcoma (CS) of the uterus. Gynecol Oncol. 2007 Nov;107(2):177-85. doi: 10.1016/j.ygyno.2007.07.070. Epub 2007 Sep 5.
- pmid
- 17822748
- type
- RESULT
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-2475a7c45f9987b0a463
- requested nct id
- NCT00002546
- primary nct id
- NCT00002546
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source file sha256
- 5c4e95734127c7fe3908f56c0336347f44fc40e9ba1ebf39006f988bcc962614
- payload sha256
- 4d5e6af7d10f59297f78d32dbca2cfb591fba059742909e53122e731312f818d
- payload
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-2475a7c45f9987b0a463
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT00002546
- occurrences
- context exact
- sicians have considered the use of adjuvant chemotherapy or radiation therapy.[<a href="#cit/section_4.2">2</a>] Another GOG study (<a href="/clinicaltrials/NCT00002546">GOG-0150</a> [NCT00002546]) addressed radiation therapy versus adjuvant chemotherapy.[<a href="#cit/section_4.3">3</a>]</p><h6 do-not-show="toc">References</h
- end
- 39258
- exact text
- NCT00002546
- start
- 39247
- context exact
- use of adjuvant chemotherapy or radiation therapy.[<a href="#cit/section_4.2">2</a>] Another GOG study (<a href="/clinicaltrials/NCT00002546">GOG-0150</a> [NCT00002546]) addressed radiation therapy versus adjuvant chemotherapy.[<a href="#cit/section_4.3">3</a>]</p><h6 do-not-show="toc">References</h6><ol><li id="section_4.1">
- end
- 39285
- exact text
- NCT00002546
- start
- 39274
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/nci/raw/87e4c91691eba06359.html
- source file sha256
- 5c4e95734127c7fe3908f56c0336347f44fc40e9ba1ebf39006f988bcc962614
- source json pointer
- Source null
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source retrieved at
- 2026-09-09T23:22:25.541847+00:00
- source string basis
- UTF-8_text_with_universal_newline_translation
- source string sha256
- f3035fef0aba3b3ce9c9d3c5d490e12661a22cbc62ca1d1e1c5d234fbe67c618
- source title
- Uterine Sarcoma Treatment (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: December 17, 2024
- datetime
- 2024-12-17T12:00:00Z
- display
- December 17, 2024
Preserved source evidence · Not medical advice