Know Cancer

forgot password

A Pilot Phase II Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With High-Risk Endometrial Cancer After Standard Surgical Staging

Phase 2
18 Years
Open (Enrolling)
Endometrial Cancer

Thank you

Trial Information

A Pilot Phase II Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With High-Risk Endometrial Cancer After Standard Surgical Staging

- Before chemotherapy, patients will receive extra fluid by IV for 2 hours, and will be
given medicine to prevent side effects from the chemotherapy drugs.

- Chemotherapy treatments will be given intravenously in the outpatient clinic. Patients
will receive IV paclitaxel/carboplatin chemotherapy every 21 days for 3 cycles.

- After 3 cycles of chemotherapy, patients will receive external beam radiotherapy.
Radiation will be delivered to the patient's pelvis at the dose prescribed by the
Radiation Oncologist.

- External radiation will be given once a day, five days a week (Monday-Friday) for 5

- Patients will then receive internal high-dose radiation, which will be given once a
week for three weeks. This type of radiation is given through a vaginal cylinder, a
device that is inserted in the vagina that directs the radiation to your tumor. It is
a procedure that is done with anesthesia.

- The 4th cycle of chemotherapy will overlap with the high dose radiation.

- The remainder of the planned 6 cycles of paclitaxel/carboplatin therapy will continue
to be administered every 21 days.

- Prior to and during the study, tests and procedures will be performed; including
physical examinations, routine blood tests, urine tests, ECG, medical history and vital
signs, radiologic examinations.

- The study treatment will proceed as long as the tumor does not grow and the patient
isn't experiencing any severe side effects.

Inclusion Criteria:

- Histologically-documented high-risk endometrioid adenocarcinoma with no visible
residual disease, defined by the following criteria:

1. Surgical stage I disease with < 50 myometrial invasion and grade 3 tumor (IBG3)
with lymphovascular space involvement;

2. Surgical stage I disease with > 50% myometrial invasion and grade 2 or 3 tumor
(ICG2, ICG3);

3. Any surgical stage II disease (IIA, IIB);

4. Any surgical stage III disease (IIIA, IIIB, IIIC); and

5. Any surgical stage IV disease with no residual macroscopic tumor

- Surgical staging to include total abdominal hysterectomy, bilateral
salpingo-oophorectomy, peritoneal washings, and lymph node samplings as per standard
GOG criteria.

- Age > 18 years.

- ECOG performance status of < 2.

Exclusion Criteria:

- 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).

- Patient has severe or uncontrolled concurrent medical disease (eg Un-controlled
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.

- Patients with any history of cancer with the exception of non-melanoma skin cancer
are excluded if there is any evidence of other malignancy being present within the
past five years.

Type of Study:


Study Design:

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

Outcome Measure:

To assess and document location of disease recurrence (distant vs. local. vs. both) using this treatment regimen.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Dennis Yi-Shin Kuo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2008

Completion Date:

May 2014

Related Keywords:

  • Endometrial Cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



Montefiore Medical Center Bronx, New York  10467-2490