Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity (WAR)
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|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Recruitment Status : Withdrawn (PI decision due to under accrual.)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|
|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|
- Drug: Cisplatin
PLATINOL®-AQ (cisplatin injection) is a clear, colorless, sterile aqueous solution, each mL containing 1 mg cisplatin and 9 mg Sodium Chloride, USP. HCl and/or Sodium Hydroxide is added to adjust pH of the solution. The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula PtCl2H6N2, and a molecular weight of 300.1. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207°C.Other Name: Cisplatin, PLATINOL®-AQ
- Radiation: Whole Abdomen Radiotherapy
Whole abdominal radiotherapy will be delivered with an open-field anterior-posterior/posterior-anterior technique. Radiation will be administered in a dose escalating fashion to determine toxicity. The maximal dose of radiation will be defined as a mean midplane dose to the abdomen of 3,000 Gy through parallel-opposed single ports with a 1-cm margin that will cover the entire abdomen including the diaphragm.Other Name: radiation therapy
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|