Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122772
Status:
COMPLETED
Last Update Posted:
2011-10-14
First Post:
2005-07-19
Brief Title:
CRP on Radiobiological and Clinical Studies on Viral-Induced Cancers Response to Radiotherapy
Sponsor:
International Atomic Energy Agency
Organization:
International Atomic Energy Agency
Study Overview
Official Title:
CRP on Radiobiological and Clinical Studies on Viral-induced Cancers Response to Radiotherapy With Comprehensive Morbidity Assessment
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to study clinical effects of twofour high dose rate HDR brachytherapy applications and teletherapy with or without weekly cisplatin in cervix cancer
Detailed Description:
This study uses 2x2 design to test external beam radiotherapy 46 Gy in 23 daily fractions with and without HDR brachytherapy 2 fractions of 9 Gy versus 4 fractions of 7 Gy with and without weekly Cisplatin 40 mgsqm The overall objective was to test the clinical outcome and toxicity of a resource-sparing schedule of radiotherapy with or without chemotherapy treatment for cervix cancer to detect molecular markers that will predict tumor controlresistance and to establish whether E6 and E7 viral proteins predict cellular radiosensitivity in oxic and hypoxic conditions in vitro and tumor controlresistance in vivo A new component of the CRP was added for which the objective is to optimize the data capture provide more details of normal tissue outcomes following cancer treatments in developing countries and validate this approach using patients participating in the ongoing CRP This will be achieved by exploring data capture using the questionnaire template on a computer in face-to-face interviews active data collection and comparing it with standard data collection obtained from the clinical notes passive data collection during the still ongoing CRP E33024 The method of data collection will be chosen at random for each case stratified by centre The reason for using an ongoing CRP is that it will test the usefulness of the new method and validate it in a multicentre study During the performance of the new CRP the same institutions as for E33024 will be engaged
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None