Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT01088802
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2009-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Study Overview
Official Title:
A Phase II Study on Treatment De-Intensification in Favorable Squamous Cell Carcinoma of the Oropharynx
Status:
COMPLETED
Status Verified Date:
2022-10
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:
This research is being done to try to reduce radiation side effects that happen with the standard radiation methods. Generally surgery, radiation therapy, and sometimes chemotherapy are standard treatment for people with squamous cell carcinoma of the oropharynx.
The study will look at giving a slightly smaller dose of radiation (de-intensification) to see if regularly expected late toxicities (two years after receiving treatment) can be reduced. This study will also try to see if the smaller dose of radiation is equally effective at treating the cancer and to see if it improves quality of life. Along with this radiation treatment plan some participants in this study will have surgery on their tumor and or receive chemotherapy (cisplatin or carboplatin). The possible surgery and or chemotherapy will be up to the participant's doctor.
Study participants will be tested for the Human Papillomavirus (HPV). This tissue test is required for this study. Some studies have suggested that HPV-related cancer is biologically and clinically different as compared to non-HPV-related cancer. Some studies have found that patients with HPV-related oropharynx cancer have a better response to treatment. This test will help researchers learn more about HPV-related cancer.
The study will look at giving a slightly smaller dose of radiation (de-intensification) to see if regularly expected late toxicities (two years after receiving treatment) can be reduced. This study will also try to see if the smaller dose of radiation is equally effective at treating the cancer and to see if it improves quality of life. Along with this radiation treatment plan some participants in this study will have surgery on their tumor and or receive chemotherapy (cisplatin or carboplatin). The possible surgery and or chemotherapy will be up to the participant's doctor.
Study participants will be tested for the Human Papillomavirus (HPV). This tissue test is required for this study. Some studies have suggested that HPV-related cancer is biologically and clinically different as compared to non-HPV-related cancer. Some studies have found that patients with HPV-related oropharynx cancer have a better response to treatment. This test will help researchers learn more about HPV-related cancer.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NA_00026771 | OTHER | JHM IRB | View |