Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06167291
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2023-12-04
Brief Title:
Phase II Randomized-registry Embedded Study of Lymphoscintigraphy for Oropharyngeal Neoplasms to Enable Risk-adapted Nodal Guidance for Robotic Surgery andor Radiotherapy LONE-RANGR2
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Randomized-registry Embedded Study of Lymphoscintigraphy for Oropharyngeal Neoplasms to Enable Risk-adapted Nodal Guidance for Robotic Surgery andor Radiotherapy LONE-RANGR2
Status:
RECRUITING
Status Verified Date:
2024-04
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 test a new radiation treatment design based on where your cancer is located Most participants with oropharyngeal cancer are treated with radiation to both sides of the neck However for participants with oropharyngeal cancer on one side of the neck receiving radiation to both sides of the neck may result in increased side effects and radiation exposure This study is testing the safety and effectiveness of an approach that involves radiation to only one side of the neck in an effort to reduce the overall amount of radiation given and decrease the amount of side effects you may experience
Detailed Description:
Primary Objectives
To determine whether
1 Omission of the contralateral neck cancer treatment is safe and toxicity-sparing for participants with well lateralized oropharyngeal HNSCC undergoing definitive or PORT radiation This will be demonstrated by acceptably low contralateral neck failures 15
Secondary Objectives
To determine
1 the relative difference in symptom burden as measured by the MDASI_HN area-under-the-toxicity curve AUC for initial surgical and initial non-surgical therapy cohorts
2 Whether omission of the contralateral neck in radiotherapy planning as definitive of PORT treatment for well-lateralized oropharyngeal tumors will impact symptom burden as measured by MDASI AUC Grade 2 or higher CTCAE v50 toxicity swallow function andor feeding tube rates and dependency
3 Risk adapted therapy approaches lead to differences in distant-metastasis-free survival DMFS ipsilateral neck failure primary site failure and whether salvage therapy for contralateral neck failures is feasible and effective compared to historical controls
To determine whether
1 Omission of the contralateral neck cancer treatment is safe and toxicity-sparing for participants with well lateralized oropharyngeal HNSCC undergoing definitive or PORT radiation This will be demonstrated by acceptably low contralateral neck failures 15
Secondary Objectives
To determine
1 the relative difference in symptom burden as measured by the MDASI_HN area-under-the-toxicity curve AUC for initial surgical and initial non-surgical therapy cohorts
2 Whether omission of the contralateral neck in radiotherapy planning as definitive of PORT treatment for well-lateralized oropharyngeal tumors will impact symptom burden as measured by MDASI AUC Grade 2 or higher CTCAE v50 toxicity swallow function andor feeding tube rates and dependency
3 Risk adapted therapy approaches lead to differences in distant-metastasis-free survival DMFS ipsilateral neck failure primary site failure and whether salvage therapy for contralateral neck failures is feasible and effective compared to historical controls
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-10400 | OTHER | NCI-CTRP Clinical Registry | None |