Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569368
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
A Phase II Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if adding metronidazole to standard therapy can decrease populations of Fusobacterium nucleatum F nucleatum and other anaerobes small organisms that cause infections in participants with rectal cancer receiving neoadjuvant therapy compared to neoadjuvant therapy alone
Detailed Description:
Primary Objectives Quantify the ability of a standard course of metronidazole to decrease populations of anaerobic bacteria from within rectal cancers in participants receiving neoadjuvant therapy
Secondary Objectives To observe and record augmented anti-tumor activity of metronidazole in combination with standard of care therapies Although the clinical benefit of thisthese drugs has not yet been established the intent of offering this treatment is to provide a possible therapeutic benefit and thus the patient will be carefully monitored for tumor response in addition to safety and tolerability
As part of the therapeutic efficacy of metronidazole in combination with standard of care therapies overall survival and recurrence free survival will be assessed among participants enrolled in the study over the two years following study completion
Quantify differential rates of pathologic response of tumors treated with metronidazole in combination with standard neoadjuvant therapy compared against historic controls Those participants undergoing watch and wait protocols will not have the pathologic response and will not be included in the pathologic response assessment
Exploratory analysis of immune and microbial infiltrates between participant matched pre and post treatment tissues when available This will include bacterial taxal populations along with populations of various immune cell populations
Secondary Objectives To observe and record augmented anti-tumor activity of metronidazole in combination with standard of care therapies Although the clinical benefit of thisthese drugs has not yet been established the intent of offering this treatment is to provide a possible therapeutic benefit and thus the patient will be carefully monitored for tumor response in addition to safety and tolerability
As part of the therapeutic efficacy of metronidazole in combination with standard of care therapies overall survival and recurrence free survival will be assessed among participants enrolled in the study over the two years following study completion
Quantify differential rates of pathologic response of tumors treated with metronidazole in combination with standard neoadjuvant therapy compared against historic controls Those participants undergoing watch and wait protocols will not have the pathologic response and will not be included in the pathologic response assessment
Exploratory analysis of immune and microbial infiltrates between participant matched pre and post treatment tissues when available This will include bacterial taxal populations along with populations of various immune cell populations
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