Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563362
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DeEscO
Brief Summary:
Multicentric prospective model-based de-escalation of the elective clinical target volumes CTV in radiotherapy of oropharyngeal carcinoma of all stages with the goal to reduce toxicity
The study investigates the feasibility of this approach as measured by the number of expected out-of-field recurrencies based on the individual patients state of disease progression and risk factors
The study investigates the feasibility of this approach as measured by the number of expected out-of-field recurrencies based on the individual patients state of disease progression and risk factors
Detailed Description:
Local treatment of squamous cell carcinoma SCC of the oropharynx can consist of surgery radiotherapy or a combination of both When treated with radiation the target volume contains not only the primary tumor and clinically detected lymph node metastases In addition a large part of the lymph drainage system of the neck which is at risk of harboring occult metastases is irradiated the so called elective clinical target volume CTV This elective CTV is currently based on clinical recommendations but there is limited data and evidence on occult lymphatic spread and the required size of the elective CTV This standard radiotherapy approach is associated with early and late toxicity Toxicities such as pain dermatitis mucositis but also long-term sequela like swallowing dysfunction lymphedema and dysgeusia are commonly described which can even lead to hospitalization or long-term symptoms with subsequent life-quality impairment
A de-escalation of the treatment could result in less toxicity Multiple studies have evaluated potential ways to de-escalate treatment and reduce toxicity such as dose reduction or change of chemotherapeutic agent Another possible de-escalation strategy which is pursued here is to reduce the elective clinical target volume
A multi-institutional dataset of 598 oropharyngeal SCC patients in whom the detailed patterns of lymph node involvement are reported was collected The publicly available online platform wwwLyProXorg was developed to share and visualize the data Based on this data a statistical model of lymphatic tumor progression to perform a statistical analysis to estimate the probability of occult metastases in the clinically negative lymph node levels was developed The patients state of metastatic lymphatic progression is described via a hidden Markov model The state of tumor progression is described by a collection of hidden binary random variables that indicate the involvement of lymph node levels The model parameters are the probabilities for the tumor to spread to and between lymph node levels and are learned from the dataset Supporting clinical experience these statistical calculations can subsequently be used as a basis to personalize the risk estimation of occult lymph node metastases in newly diagnosed patients based on their distribution of macroscopic metastases T-stage and lateralization of the primary tumor A table with the possible different combinations of clinically observed lymph node involvement and the associated risk of occult lymph node involvement in the remaining clinically negative lymph node levels LNL was created By interpreting the results from both the statistical analysis and clinical experience the elective clinical target volume CTV was personalized based on a patients individualized risk profile As a final measure of quality assurance the elective CTVs CTV-3s constructed in this way have been discussed individually by the investigators to ensure consistency with data and clinical judgement and experience This leads to a reduction of irradiated volume and potentially to a reduction in early and late toxicity
The aim of this clinical trial is to determine the safety of the use of a personalized de-escalated elective nodal CTV in oropharynx SCC patients treated with primary chemoradiotherapy
A de-escalation of the treatment could result in less toxicity Multiple studies have evaluated potential ways to de-escalate treatment and reduce toxicity such as dose reduction or change of chemotherapeutic agent Another possible de-escalation strategy which is pursued here is to reduce the elective clinical target volume
A multi-institutional dataset of 598 oropharyngeal SCC patients in whom the detailed patterns of lymph node involvement are reported was collected The publicly available online platform wwwLyProXorg was developed to share and visualize the data Based on this data a statistical model of lymphatic tumor progression to perform a statistical analysis to estimate the probability of occult metastases in the clinically negative lymph node levels was developed The patients state of metastatic lymphatic progression is described via a hidden Markov model The state of tumor progression is described by a collection of hidden binary random variables that indicate the involvement of lymph node levels The model parameters are the probabilities for the tumor to spread to and between lymph node levels and are learned from the dataset Supporting clinical experience these statistical calculations can subsequently be used as a basis to personalize the risk estimation of occult lymph node metastases in newly diagnosed patients based on their distribution of macroscopic metastases T-stage and lateralization of the primary tumor A table with the possible different combinations of clinically observed lymph node involvement and the associated risk of occult lymph node involvement in the remaining clinically negative lymph node levels LNL was created By interpreting the results from both the statistical analysis and clinical experience the elective clinical target volume CTV was personalized based on a patients individualized risk profile As a final measure of quality assurance the elective CTVs CTV-3s constructed in this way have been discussed individually by the investigators to ensure consistency with data and clinical judgement and experience This leads to a reduction of irradiated volume and potentially to a reduction in early and late toxicity
The aim of this clinical trial is to determine the safety of the use of a personalized de-escalated elective nodal CTV in oropharynx SCC patients treated with primary chemoradiotherapy
Study Oversight
Has Oversight DMC:
None
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?:
None