Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205485
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-12-11
Brief Title:
Neoadjuvant Chemotherapy Excision And Observation vs Chemoradiotherapy For Rectal Cancer
Sponsor:
Canadian Cancer Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy Excision And Observation Versus Chemoradiotherapy For Early Rectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
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:
NEO-RT
Brief Summary:
This study is being done to answer the following questions Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery If radiation therapy is not given is quality of life better
Detailed Description:
This study is being done to find out if this approach is better or worse than the usual approach for early rectal cancer The usual approach is defined as care most people get for early rectal cancer
The usual approach for patients who are not in a study is surgery to remove the rectum or treatment with chemotherapy and radiation therapy followed by surgery There are several chemotherapy drugs approved by Health Canada that are commonly used with radiation therapy For patients who get the usual approach for this cancer about 90 out of 100 are free of cancer after 5 years
If a patient decides to take part in this study they will either get a combination of chemotherapy drugs called FOLFOX or CAPOX for up to 12 weeks or will get chemotherapy with radiation therapy for up to 6 weeks
After finishing treatment and even if treatment is stopped early the study doctor will watch for side effects and determine which type of surgery would be best After surgery patients will be asked to come in every 4 months for 2 years then every 6 months for an additional year Then will be checked every year for 2 years This means seeing the study doctor for up to 5 years after surgery Patients may be seen more often if your study doctor thinks it is necessary
The usual approach for patients who are not in a study is surgery to remove the rectum or treatment with chemotherapy and radiation therapy followed by surgery There are several chemotherapy drugs approved by Health Canada that are commonly used with radiation therapy For patients who get the usual approach for this cancer about 90 out of 100 are free of cancer after 5 years
If a patient decides to take part in this study they will either get a combination of chemotherapy drugs called FOLFOX or CAPOX for up to 12 weeks or will get chemotherapy with radiation therapy for up to 6 weeks
After finishing treatment and even if treatment is stopped early the study doctor will watch for side effects and determine which type of surgery would be best After surgery patients will be asked to come in every 4 months for 2 years then every 6 months for an additional year Then will be checked every year for 2 years This means seeing the study doctor for up to 5 years after surgery Patients may be seen more often if your study doctor thinks it is necessary
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-10515 | OTHER | NCI CTRP | None |
| CCTG-CO32 | OTHER | None | None |