Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
Study NCT ID:
NCT06569368
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2024-08-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy
Sponsor:
M.D. Anderson Cancer Center
Organization:
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:
2025-10
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:
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 \[this/these\] drug(s) 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 \[this/these\] drug(s) 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:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-07395 | OTHER | NCI-CTRP Clinical Registry | View |