Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:18 PM
Study NCT ID:
NCT07221058
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adaptive Radiation Boost for Rectal Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Study Overview
Official Title:
Adaptive Radiation BOost for Rectal Cancer: a Phase I Dose Escalation Study (ARBOR)
Status:
RECRUITING
Status Verified Date:
2025-12
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:
ARBOR
Brief Summary:
The goal of this clinical trial is to find out if giving extra adaptive radiation therapy after standard chemoradiation treatment is safe and helpful for people with rectal cancer.
The main questions the study aims to answer are:
* Can this approach help target the most aggressive cancer cells more accurately, while protecting nearby healthy tissue?
* Can it reduce the side effects that people may experience during treatment?
Participants will:
* First receive standard treatment: radiation (45 Gy in 25 sessions) along with a chemotherapy pill called capecitabine.
* Then get extra radiation using MRI scans every two weeks to adjust the treatment based on how the tumor responds.
* Use a small balloon during treatment to help aim the radiation and protect healthy areas.
* Finally, receive additional chemotherapy (such as FOLFOX) for four months.
The main questions the study aims to answer are:
* Can this approach help target the most aggressive cancer cells more accurately, while protecting nearby healthy tissue?
* Can it reduce the side effects that people may experience during treatment?
Participants will:
* First receive standard treatment: radiation (45 Gy in 25 sessions) along with a chemotherapy pill called capecitabine.
* Then get extra radiation using MRI scans every two weeks to adjust the treatment based on how the tumor responds.
* Use a small balloon during treatment to help aim the radiation and protect healthy areas.
* Finally, receive additional chemotherapy (such as FOLFOX) for four months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 25-1024 | OTHER | FCCC IRB | View |