A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
- Each treatment cycle lasts four weeks during which time participants will receive
oxaliplatin and gemcitabine the first week and the third week. During the second and
fourth week, they will not receive the study medication.
- After three cycles of chemotherapy treatment, participants will then get radiation
therapy five days a week for five weeks.
- At the start of each cycle participants will have a physical exam and be asked
questions about their general health and specific questions about any problems that
they might be having and any medications they may be taking.
- Prior to each chemotherapy treatment they will also have the following: blood tests
and neurology exam. After three cycles of treatment they will have an assessment of
their tumor by x-ray, CT scan, or MRI.
- After the final radiation treatment, CT scans will be done every three months for up to
two years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the feasibility of dual modality therapy described as cytotoxic therapy followed by radiation therapy for the management of Malignant Mixed Mullerian Tumors (MMMTs).
2 years
No
Susana Campos, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Institutional Review Board
06-063
NCT00476086
August 2006
August 2013
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |