Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity (WAR)
|ClinicalTrials.gov Identifier: NCT00942838|
Recruitment Status : Withdrawn (PI decision due to under accrual.)
First Posted : July 21, 2009
Last Update Posted : July 24, 2013
The proposed study is a prospective cohort study incorporating patients with first recurrence ovarian or primary peritoneal cancer who will receive intraperitoneal chemotherapy in conjunction with whole abdomen radiation. The primary end point of this investigator initiated research study is to determine the toxicity associated with whole abdomen radiation in combination with intraperitoneal chemotherapy.
- Determine the maximum tolerated dose (MTD) of whole abdomen radiation in conjunction with intraperitoneal cisplatin chemotherapy in the treatment of women with small volume (< 1 cm) recurrent ovarian cancer confined to the abdominal peritoneal cavity.
- Quality of Life assessment.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Ovarian Carcinoma||Drug: Cisplatin Radiation: Whole Abdomen Radiotherapy||Phase 1|
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DESIGN: This is an open label, single arm, dose finding study.
STUDY PROCEDURES: Patients will receive chemotherapy and radiation for four weeks, and we will check for any problems from the treatment for 3 months. We would like to collect information from the patients regular doctor for 1 year after this treatment.
Pre-screening If patients decide to participate in this study the doctor will evaluate if they have met all the criteria to be eligible. To participate the cancer cannot have spread outside the abdomen and patients must have had only one type of chemotherapy for their cancer. If there any of their previous scans or blood tests show that the cancer has spread outside the abdominal cavity, patients will not be able to participate in this study. Patients will also not be able to participate in this study if it is determined that their cancer has come back less than six months after they completed their first treatment of chemotherapy. If these criteria are met, the standard next step for treatment is to have a second surgery to remove all or most of the cancer from the abdominal cavity. This will involve a similar surgery to what patients had when their cancer was first diagnosed. During this surgery we will place a special catheter or tube within the abdominal cavity so that we can administer chemotherapy into the abdomen directly and deliver it to the remaining cancer.
The following screening tests, exams and procedures will be done:
- Recording of medical history, physical exam (including vital signs, height & weight assessment, pelvic examination)
- Blood tests (approximately 2-3 teaspoons will be drawn)
- Urine tests
- Quality of life questionnaire
- If patients have a history of hearing loss, they will have a hearing test because cisplatin can affect hearing.
Chemotherapy and Radiation Treatment:
- Chemotherapy (Cisplatin) will be given to after recovery from surgery. It will be given once per week at the same time as patients begin receiving the radiation treatment for the first 4 weeks. The chemotherapy will be given through the catheter (tube) that was placed under the skin during surgery and will not be visible. Patients will receive medication prior to the chemotherapy to prevent nausea, vomiting, and possible allergic reaction. Each infusion of chemotherapy will take approximately 60 minutes. After patients receive the drug we will ask to change positions to ensure that the drug comes in contact with all parts of the abdomen.
- Radiation therapy will be administered for four weeks. Radiation treatments will be given every day (Monday through Friday) for approximately four weeks.
- Weekly blood tests will be taken before patients receive the chemotherapy (approximately 2-3 teaspoons) to monitor the effects of the drug on the body.
- The study doctor will evaluate patients weekly with a physical exam and review their blood tests for any side effects they might be having from the chemotherapy or radiation treatments.
- Complete a quality of life questionnaire each week.
At the end of treatment (beginning of week 5) AND approximately 90 days after the completion of treatment patients will have a physical exam, blood tests evaluation of the side effects, and will complete a quality of life questionnaire.
At the end of treatment, patients will likely undergo additional standard chemotherapy treatment. We would like to collect and review the information about their progress and care for 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity: A Phase I Trial|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
U.S. FDA Resources
- Determine the maximum tolerated dose (MTD) of whole abdomen radiation in conjunction with intraperitoneal cisplatin chemotherapy in the treatment of women with small volume (< 1 cm) recurrent ovarian cancer confined to the abdominal peritoneal cavity [ Time Frame: 2 years after study start ]
- Quality of Life assessment [ Time Frame: 2 years after study start ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942838
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Andrew P. Soisson||Huntsman Cancer Institute|