Radiation With Chemotherapy and a Study Drug to the Para-Aortic Nodes in Cervical Cancer
|First Received Date ICMJE||August 26, 2005|
|Last Updated Date||January 23, 2013|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The primary objective is to determine the maximum tolerated dose (MTD) of external beam radiation to the para-aortic lymph nodes using IMRT and amifostine.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00137358 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||The secondary endpoints include local-regional control, overall survival and toxicity.|
|Original Secondary Outcome Measures ICMJE
||The secondary endpoints include local-regional control, overall survival and toxicity|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Radiation With Chemotherapy and a Study Drug to the Para-Aortic Nodes in Cervical Cancer|
|Official Title ICMJE||Phase I Trial of Dose Escalated IMRT to the Para-aortic Nodes With Concurrent Cisplatin and Amifostine in Locally Advanced Cervical Cancer|
Investigator has since decided not to pursue this protocol further. No patients were enrolled.
This study is to determine the maximum tolerated dose of external beam radiation to the para-aortic lymph nodes using intensity modulated radiation therapy (IMRT).
This protocol will test the hypothesis that the use of IMRT and amifostine will decrease GI toxicity and therefore allow the radiation dose to the para-aortic lymph nodes to be safely escalated.
This is a Phase I open-label multi-institutional study that will enroll a minimum of 27 and up to 42 patients with locally advanced cervical cancer (a minimum of 27 will be entered if all dose levels are explored without reaching a dose limiting toxicity at any level). The primary objective is to determine the maximum tolerated dose (MTD) of external beam radiation to the para-aortic lymph nodes using IMRT and amifostine. Patients will be stratified according to gross tumor volume (GTV) prior to dose escalation.
Within each GTV stratum, the dose escalation will be determined as follows: Accrue 3 patients in the first dose level based on the determined stratum. A Dose Limiting Toxicity is defined as the development of > Grade 3 acute GI toxicity, per the RTOG acute toxicity scale. If no DLT is observed at the first dose level, 3 patients will be enrolled at the next dose level. If one patient experiences DLT at a given dose level, 3 additional patients will be enrolled at that dose level. If 0 of these 3 additional patients experience DLT, dosing of the next dose level is begun. If 1 or more of these 3 additional patients experience DLT at the highest dose level below the maximally administered dose, this dose becomes the recommended dose. At least 6 patients must be entered at this recommended dose. The Maximum Tolerated Dose (MTD) is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Cervical Cancer|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||19 Years and older|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00137358|
|Other Study ID Numbers ICMJE||ETH175-04D|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Jennifer F. De Los Santos, University of Alabama at Birmingham|
|Study Sponsor ICMJE||University of Alabama at Birmingham|
|Collaborators ICMJE||MedImmune LLC|
|Information Provided By||University of Alabama at Birmingham|
|Verification Date||January 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP