Uterine Cancer Clinical Trial
Official title:
A Pilot Phase II Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma
NCT number | NCT00231868 |
Other study ID # | 01-09-227 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | December 2001 |
Est. completion date | July 2011 |
Verified date | August 2020 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Combination chemo/radiotherapy trials in advanced/recurrent endometrial cancer are ongoing.
The optimal radiation modality, chemotherapeutic agents, and sequence of these regimens for
the treatment of UPSC are yet to be established. A retrospective review of 16 patients
treated at our institution with the sequential use of radiation "sandwiched" between
paclitaxel/platinum chemotherapy found only one patient to have recurred at 16 months with a
median follow-up of 15 months (range 6-33 months). The regimen was well tolerated. Eight of
the sixteen patients (50%) developed grade 3 neutropenia following cycle 4 of chemotherapy,
two of which required a 1 week treatment delay. There were no cases of grade 3 or 4
thrombocytopenia noted. There was no febrile neutropenia and no hospital admissions for
toxicity. There were no observed grade 3 or 4 non-hematologic toxicities. With the median
follow up of 15 months, we have not observed late toxicities.
Given these favorable preliminary findings, supported by recently published data documenting
efficacy of the "sandwich" multimodality technique in other difficult uterine malignancies
(malignant mixed mullerian tumors), we propose to study this combination of chemotherapy and
radiation prospectively. Our aim is to better evaluate patterns of recurrence and possible
benefits in progression-free and overall survival.
Status | Completed |
Enrollment | 81 |
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: 1. Histologically documented uterine papillary serous carcinoma (UPSC) with no visible residual disease. 2. Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings. 3. Age > 18 years. 4. ECOG performance status of < 2. 5. Written voluntary informed consent. Exclusion Criteria: 1. Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values: 1. Serum SGOT and /or SGPT > 2.5 times the institutional upper limit of normal 2. Total serum bilirubin > 1.5 mg/dl 3. History of chronic or active hepatitis 4. Serum creatinine > 2.0 mg/dl 5. Platelets < 100,000/mm3 6. Absolute neutrophil count (ANC) < 1500/mm3 7. Hemoglobin < 8.0 g/dl (the patient may be transfused prior to study entry) 2. Patient has severe or uncontrolled concurrent medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.) 3. Patient has been treated with myelosuppressive chemotherapy within three weeks prior to study entry. 4. Patient with any prior chemotherapy or radiotherapy for pelvic malignancy. 5. Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry. |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
Einstein MH, Frimer M, Kuo DY, Reimers LL, Mehta K, Mutyala S, Huang GS, Hou JY, Goldberg GL. Phase II trial of adjuvant pelvic radiation "sandwiched" between combination paclitaxel and carboplatin in women with uterine papillary serous carcinoma. Gynecol — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To Evaluate the Toxicity and Tolerability of Pelvic Radiation "Sandwiched" Between Cycles of Paclitaxel/Carboplatin Chemotherapy in Patients With UPSC | Overall survival analysis of early stage (stage 1 & 2) and late stage (stage 3 & 4)UPSC patients who were prescribed radiation "sanwhiched" between three cycles of paclitaxel/platinum chemotherapy before and after RT. Outcome measures were Progression Free Survival (PFS) and Overall Survival (OS). | Up to 7 years |
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