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A Pilot Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Carcinosarcoma

Phase 2
18 Years
Open (Enrolling)
Uterine Carcinosarcoma

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Trial Information

A Pilot Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Carcinosarcoma

Uterine carcinosarcomas represent approximately 4% of primary uterine malignancies.
However, our rates in the Bronx are about double the national rate likely due to a number of
factors including the referral patterns and the ethnic and racial diversity of the community
the investigator serve at Montefiore Medical Center. Carcinosarcoma is an aggressive
uterine tumor with a poor prognosis and a recurrence rate of 53%. Sites of failure include
pelvic and extrapelvic with most patients developing extrapelvic disease. Pelvic radiation
decreases the risk of pelvic recurrence, but has not been shown to improve overall survival
secondary to extrapelvic recurrences and the hematogenous route of metastasis. Use of
radiotherapy alone does not control extrapelvic recurrences. Combination chemotherapy has
been shown to provide an improvement in response rate but with increased toxicity. The
investigators have had considerable experience here at Montefiore combining sequenced
radiation therapy sandwiched with chemotherapy before and after radiation therapy for both
carcinosarcoma and uterine papillary serous carcinoma. In our most recent carcinosarcoma
trial, 27 patients with surgical stage 1-4 uterine carcinosarcoma, without evidence of gross
disease, were treated with adjuvant ifosfamide/cisplatin or ifosfamide for three cycles,
then received pelvic external beam radiotherapy and brachytherapy followed by three more
cycles of ifosfamide/cisplatin or ifosfamide. The two year disease free survival for stage
I patients was 18.75 months and for stages II-IV was 15.81 months. Similar to a GOG trial
in the recurrent setting, in our adjuvant trial, toxicity was increased in patients who
received ifosfamide with cisplatin without added efficacy. Thus, in the last cohort of this
trial, the investigators dropped the cisplatin from the regimen because it was adding
toxicity without benefit. In our uterine papillary serous carcinoma "sandwich" trial, 30
patients with surgical stages I-IV, without evidence of gross residual disease received
adjuvant paclitaxel/platinum for three cycles, followed by external beam pelvic radiotherapy
and brachytherapy, and then three more cycles of paclitaxel/platinum. The three year
disease free survival for stage I/II patients was 69% and for stage III/IV patients was 54%.
29 out of the 30 patients completed the protocol with grade 3/4 neutropenia occurring in
42% of cycles. 6 out of 177 cycles were delayed 1 week for neutropenia. Both in-house
trials of sequenced chemotherapy and radiation therapy resulted in higher than expected
survival in the adjuvant setting. Multiple studies have demonstrated a response of
carcinosarcoma to carboplatin and paclitaxel as well as the role of adjuvant radiotherapy in
improvement in local control. Due to the recent reports of efficacy of paclitaxel and
carboplatin in recurrent carcinosarcoma, this pilot protocol is designed to determine the
toxicity and clinical benefit of radiation therapy "sandwiched" between three cycles of
paclitaxel and carboplatin before and after radiation therapy.

Inclusion Criteria:

- Histologically documented uterine carcinosarcoma with no visible residual disease.

- Surgical staging to include total abdominal hysterectomy, bilateral salpingo-
oophorectomy, peritoneal washings, and lymph node samplings.

- Patients must be entered no more than 12 weeks post operatively.

- Age > 18 years.

- ECOG performance status of < 2.

- Written voluntary informed consent.

Exclusion Criteria:

- Patient has impairment of hepatic, renal or hematologic function as defined by the
following baseline laboratory values:

- Serum SGOT and /or SGPT > 2.5 times the institutional upper limit of normal

- Total serum bilirubin > 1.5 mg/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 concurrent medical disease (eg. uncontrolled
diabetes, unstable angina, myocardial infarction within 6 months, congestive heart
failure, etc.)

- Patient 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 the time of study entry.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recurrence-Free Survival

Outcome Description:

Recurrence-free survival is defined as date of entry to date of reappearance of disease. Site(s) and date of relapse will be recorded. Recurrent disease will be defined as pelvic or distant. Pelvic sites will be specified as vaginal or other, and distant sites will be specified as to their anatomic location. Relapse should be confirmed by histologic or cytologic evaluation when possible.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Merieme Klobocista, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2011

Completion Date:

Related Keywords:

  • Uterine Carcinosarcoma
  • Uterine Carcinosarcoma
  • Radiation Therapy
  • Paclitaxel
  • Carboplatin
  • Carcinosarcoma
  • Mixed Tumor, Mullerian
  • Uterine Neoplasms



Montefiore Medical CenterBronx, New York  10467-2490