Uterine Cancer Clinical Trial
Official title:
A Pilot Phase II Trial of Adjuvant Radiation Therapy "Sandwiched" Between Ifosfamide in Patients With Mixed Mesodermal Tumors
NCT number | NCT00231842 |
Other study ID # | 03-02-040 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | February 2003 |
Est. completion date | July 2011 |
Verified date | January 2019 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The optimal sequence and /or modality for adjuvant therapy in the management of Mixed
Mesodermal Tumors (MMT) clearly remains to be established. The rationale for the protocol is
to "sandwich" pelvic radiation with chemotherapy to decrease distant metastasis.
The proposed study will sandwich radiation between the two most active chemotherapeutic
agents for MMT identified to date (ifosfamide/cisplatin). By doing so, we attempt to decrease
both local and distant recurrence, which may translate into an improved progression free
interval and possibly even extend survival.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically documented mixed mesodermal tumor (MMT) of uterus with no visible residual disease. - Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node sampling. - Surgical staging should be completed 6 weeks ± 7 days prior to enrollment. - Age >= 18 years. - Written voluntary informed consent. Exclusion Criteria: - Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values: - Total serum bilirubin >1.5mg/dl - History of chronic or active hepatitis - Serum creatinine >2.0 mg/dl - Platelets <100,000/mm3 - Absolute neutrophil count (ANC) <1500/mm3 - Hemoglobin <8.0 g/dl (the patient may be transfused prior to study entry) - Patient has severe or uncontrolled medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.) - Patient has been treated with myelosuppressive chemotherapy within three weeks prior to study entry. - Patients with any prior chemotherapy or radiotherapy for pelvic malignancy. - Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at time of study entry. - Patient has a uterine sarcoma other then mixed mesodermal tumor (MMT). |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
Einstein MH, Klobocista M, Hou JY, Lee S, Mutyala S, Mehta K, Reimers LL, Kuo DY, Huang GS, Goldberg GL. Phase II trial of adjuvant pelvic radiation "sandwiched" between ifosfamide or ifosfamide plus cisplatin in women with uterine carcinosarcoma. Gynecol — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cycles With Hematologic Toxicities | Out of 162 planned cycles, a total of 138 cycles (85%) were administered. Number of cycles during which participants with grades 3 and 4 experienced hematologic toxicities are reported. Most of the toxicities were self-limiting. | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03285802 -
Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation
|
Phase 2/Phase 3 | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Not yet recruiting |
NCT05998811 -
Insights Into Participating in Studies for Uterine Cancer
|
||
Not yet recruiting |
NCT06369155 -
Azenosertib in Uterine Serous Carcinoma: Biomarker Study
|
Phase 2 | |
Completed |
NCT01399658 -
Image-Guided Gynecologic Brachytherapy
|
Phase 2 | |
Completed |
NCT01432015 -
Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting
|
Phase 4 | |
Recruiting |
NCT02349958 -
Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy
|
Phase 2 | |
Completed |
NCT00581646 -
Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance
|
N/A | |
Completed |
NCT00284427 -
Safety of Antioxidants During GYN Cancer Care
|
Phase 2 | |
Completed |
NCT00147680 -
Uterine Papillary Serous Cancer (UPSC) Trial
|
Phase 2 | |
Recruiting |
NCT05743517 -
Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment)
|
N/A | |
Recruiting |
NCT05916196 -
[18F]FES PET/.CT in Uterine Cancer
|
Phase 2 | |
Withdrawn |
NCT04368130 -
SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care
|
N/A | |
Active, not recruiting |
NCT03668340 -
AZD1775 in Women With Recurrent or Persistent Uterine Serous Carcinoma or Uterine Carcinosarcoma
|
Phase 2 | |
Completed |
NCT00588640 -
Study of D-Methadone in Patients With Chronic Pain
|
Phase 1/Phase 2 | |
Recruiting |
NCT05990426 -
Alternate Day Fasting After Surgery for Patients Undergoing Chemotherapy
|
N/A | |
Completed |
NCT03701529 -
Effect of Anesthetic Agents on Optic Nerve Sheath Diameter
|
N/A | |
Recruiting |
NCT05758688 -
Whole Pelvis Proton Radiation for Gynecologic Cancer
|
N/A | |
Completed |
NCT01953107 -
Oral Iron vs. Placebo in Newly Diagnosed Gynecologic Oncology Patients Who Are Surgical Candidates.
|
Phase 4 |