Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity
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|ClinicalTrials.gov Identifier: NCT01163552|
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : June 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pleural Metastases Breast Cancer Colon Cancer Ovarian Cancer Uterine Cancer Renal Cell Cancer Thymic Cancer||Procedure: Surgical debulking and Intrathoracic Hyperthermic Chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Surgical Cytoreduction Followed by Intraoperative Intrathoracic Hyperthermic Chemotherapy Perfusion for the Management of Disseminated Pleural Malignancies|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Experimental: Surgical Debulking and Intrathoracic Hyperthermic Chemotherapy
Patients in this trial will undergo surgical debulking followed by intrathoracic hyperthermic chemotherapy perfusion.
Procedure: Surgical debulking and Intrathoracic Hyperthermic Chemotherapy
Surgical debulking of intrathoracic metastases will be performed, followed by perfusion of the chest with heated Cisplatin for 60 minutes.
- Time to disease progression [ Time Frame: 1 year ]Most cancers that have spread to the chest cavity have limited survival. Response to systemic chemotherapy and radiation therapy is short-lived. This end point will determine the time to disease progression of this experimental treatment modality.
- Survival [ Time Frame: 1 year ]Most cancers that have spread to the chest cavity have limited survival. Response to systemic chemotherapy and radiation therapy is short-lived. This end point will determine the overall survival period following treatment with this experimental modality.
- Systemic drug absorption [ Time Frame: 1 month ]By perfusing the chest cavity with chemotherapy, higher doses can be safely administered as less drug is absorbed systemically and therefore toxicity should be lower. This end point will assess drug toxicity due to intrathoracic perfusion.
- Complications [ Time Frame: 1 month ]Patients will undergo surgical debulking prior to intrathoracic chemotherapy perfusion. Complications from the surgery as well as inhibited wound healing from chemotherapy will be monitored as a secondary end point.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163552
|United States, New York|
|St. Luke's-Roosevelt Hospital Center|
|New York, New York, United States, 10019|
|Principal Investigator:||Cliff P Connery, MD||St. Luke's-Roosevelt Hospital Center, Division of Thoracic Surgery|