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| Sponsor: | University of Utah |
|---|---|
| Information provided by: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT00942838 |
Purpose
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.
Primary Objective:
Secondary Objective:
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Ovarian Carcinoma |
Drug: Cisplatin Radiation: Whole Abdomen Radiotherapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment |
| 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 |
| Estimated Enrollment: | 25 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
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.
Screening Procedures:
The following screening tests, exams and procedures will be done:
Chemotherapy and Radiation Treatment:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Suzanne Dodd | 801-587-9834 | suzanne.dodd@hci.utah.edu |
| Contact: Jessica Moehle | 801-587-4438 | jessica.moehle@hci.utah.edu |
| United States, Utah | |
| Huntsman Cancer Institute | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Principal Investigator: | Andrew P. Soisson | Huntsman Cancer Institute |
More Information
| Responsible Party: | Huntsman Cancer Institute ( Andrew Soisson, MD ) |
| Study ID Numbers: | HCI 28777 |
| Study First Received: | July 17, 2009 |
| Last Updated: | January 8, 2010 |
| ClinicalTrials.gov Identifier: | NCT00942838 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Recurrent Ovarian Carcinoma Cancer |
|
Disease Attributes Ovarian Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Pharmacologic Actions Recurrence |
Carcinoma Adnexal Diseases Genital Diseases, Female Neoplasms Pathologic Processes Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Therapeutic Uses Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |