Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-30 @ 7:23 AM
Study NCT ID:
NCT01047969
Status:
UNKNOWN
Last Update Posted:
2019-06-13
First Post:
2010-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Avoiding Surgery in Rectal Cancer After Pre-Operative Therapy
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Study Overview
Official Title:
Non-Operative Treatment for Rectal Cancer Following Complete Response to Neo-Adjuvant Therapy
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 objective of Timing and Deferral of Rectal Surgery Following a Continued Response to Pre-operative CRT study is to establish the time to maximum tumour response following CRT, and to investigate whether surgery can be safely avoided within the tight framework of the trial follow-up protocol in a small group of patients where the cancer becomes undetectable by imaging modalities.
Detailed Description:
The study uses MRI in combination with FDG-PET CT and clinical examination (tri-modality assessment) to assess for a continued incremental response to CRT. Surgery is NOT withheld from patients entering this study. Indeed, surgery is an option at each stage of patient follow-up and is a crucial component of a patient's treatment pathway should no further regression of disease be detected through stringent follow-up. If a status of 'no detectable disease' by serial MRI, CT-PET and clinical assessment is achieved and the patient wishes not to have surgery, they will continue to be carefully monitored within the framework of the trial follow-up protocol.
Study Oversight
Has Oversight DMC:
False
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?: