De-Intensification of Postoperative Radiotherapy in Patients with Squamous Cell Carcinoma of the Head and Neck (DIREKHT2)

Overview
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This randomized, prospective, multicenter phase II/III trial will study the reduction of radiation volume by eliminating radiotherapy (RT) to the elective neck using strictly defined surgical and radio-oncological standards to reduce radiotherapy-related long-term side effects without affecting locoregional control.

Programme: De-Intensification of Postoperative Radiotherapy in Patients with Squamous Cell Carcinoma of the Head and Neck (DIREKHT2)

SEEK ID: https://ldh.uker.imise.uni-leipzig.de/projects/4

Public web page: Not specified

NFDI4Health PALs: No PALs for this Project

Project start date: 26th Jan 2024

Project end date: 1st Sep 2033

Extended Metadata (Nfdi4Health MDS 3.3)

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Resource classification(*)

Type of the resource : Registry

Title(s)/name(s) of the Project

Title/name : De-Intensification of Postoperative Radiotherapy in Patients with Squamous Cell Carcinoma of the Head and Neck
Language of the title/name : English

Acronym(s) of the Project

Acronym : DIREKHT2
Language of the acronym : English

Description(s) of the Project

Description : This study aims to determine whether it is possible to achieve an individual target volume concept that eliminates elective irradiation of uninvolved lymph drainage areas while maintaining clearly defined surgical standards and using modern imaging and radiation techniques. The aim of this study is to achieve reduced late toxicity without compromising locoregional control. Patients will be randomized to: either RT to primary tumor region, regions with lymph node metastases and elective nodal irradiation (control arm) or RT to primary tumor region and regions with lymph node metastases without elective nodal irradiation (investigational arm) A two-stage design was chosen for this purpose. Phase II: A randomized phase II study whose primary endpoint is the 1-year percutaneous endoscopic gastrostomy (PEG) tube dependence rate will be performed first. Phase III: If the primary endpoint of the phase II study is met and the interim analysis shows no increase in the locoregional recurrence rate in the study/investigational arm, the study will be continued as a phase III study whose primary endpoint is the locoregional control rate.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : clinical trial

Keyword(*) : phase II

Keyword(*) : phase III

Keyword(*) : radiotherapy

Keyword(*) : squamos cell carcinoma

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Data curator
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Universitätsklinikum Erlangen, Medizinisches Zentrum für Informations- und Kommunikationstechnik (MIK), Datenintegrationszentrum (DIZ)
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Forschung.MIK(at)uk-erlangen.de
Phone number : +49 9131 8549444
Organisation(s) associated with the contributor
Name(*) : Barbara Bärthlein
Address : Krankenhausstraße 12, 91052, Erlangen, Germany
Web page : https://www.mik.uk-erlangen.de/ueber-uns/datenintegrationszentrum/forschungs-it/
Digital identifier(s)
Identifier(*) : 0030f2a11
Scheme(*) : ROR

Alternative identifiers

Type of the registry(*) : NCT (ClinicalTrials.gov)
Identifier(*) : NCT06030440

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Parallel
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Squamous Cell Carcinoma of the Oral Cavity
Terminology/classification(*) : ICD-10
Code of the health condition or disease : C06.9
Primary health condition or disease name(*) : Squamous Cell Carcinoma of the Larynx
Terminology/classification(*) : ICD-10
Code of the health condition or disease : C32.9
Primary health condition or disease name(*) : Squamous Cell Carcinoma of the Hypopharynx
Terminology/classification(*) : ICD-10
Code of the health condition or disease : C13.9
Primary health condition or disease name(*) : Squamous Cell Carcinoma of the Oropharynx
Terminology/classification(*) : ICD-10
Code of the health condition or disease : C10.9
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Neoplasms (II)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Yes, with cause of death
Administrative information about the Project
Status of the ethics committee approval : Not specified
Overall Project status : Not specified
Participants enrolled by invitation? : Not specified
Start date : Not specified
End date : Not specified
Mono- or multicentric? : Not specified
Number of centers : Not specified
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : 999
Unit of age(*) : Years
Eligible gender : Male, Female, Diverse
Inclusion criteria : Histologically proven squamous cell carcinoma of the oral cavity/larynx/oro-or hypopharynx (except glottis cancer (pT1/2pN0)) - Kriterium 1; Surgery of primary tumor and neck dissection performed according to predefined surgical standard - Kriterium 2; Indication for postoperative radio(chemo)therapy - Kriterium 3; No lymph node metastases > 6cm - Kriterium 4; Lymph node metastases in not more than 3 lymph node level - Kriterium 5; No distant metastases (cM0) - Kriterium 6; Age ≥ 18 years, no upper age limit - Kriterium 7; Eastern Cooperative Oncology Group (ECOG) ≤ 2 - Kriterium 8; Patients who understood protocol contents and are able to behave according to protocol - Kriterium 9; Signed study-specific consent form prior to therapy - Kriterium 10; Start of radiotherapy at least 6 weeks after last tumor-specific surgery (e.g. resection primary tumor, neck dissection, excluded are surgeries according to wound healing complications) - Kriterium 11;
Exclusion criteria : macroscopic incomplete resection R2 - Kriterium 1; Distant metastases (cM1) - Kriterium 2; Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy) - Kriterium 3; Lymph node metastases in > 3 lymph node level - Kriterium 4; pregnant or lactating/nursing women - Kriterium 5; fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment - Kriterium 6; Any condition potentially hampering compliance with the study protocol and follow-up schedule - Kriterium 7; On-treatment participation on other clinical therapeutic trials - Kriterium 8; Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the head and neck region, prior chemo- or immunotherapy (neoadjuvant/induction)) - Kriterium 9; Patients who have contraindication for MRI and CT with contrast agent (both) - Kriterium 10; Prior (> 2 months before beginning of radio(chemo)therapy) neck dissection or surgery in the head and neck area affecting lymph drainage - Kriterium 11; History of another primary malignancy except for malignancy treated with curative intent and with no known active disease ≥5 years before diagnosis of head and neck cancer, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ without evidence of disease - Kriterium 12
Population of the Project(*)
Coverage : Regional
Country(ies) : Germany
Region(s) and/or city(ies) : Erlangen
Interventions of the Project
Name of the intervention(*) : Not specified
Type of the intervention : Not specified
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Standard of care radiationtherapy
Type of the exposure : Radiation
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Active Comparator: Control Arm postoperative radiotherapy of the head and neck region according to current standard including elective nodal irradiation
Name of the exposure : Eliminating radiationtherapy to the elective neck
Type of the exposure : Radiation
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Experimental: Investigational Arm postoperative radiotherapy of the head and neck region without elective nodal irradiation
Outcome measures in the Project
Name of the outcome measure(*) : Phase II: 1-year PEG feeding tube dependence rate
Description of the outcome measure : observe change of PEG-dependence due to different target volumes
Type of the outcome measure : Primary
Time point(s) of assessment : PEG-dependent 1 year after radiotherapy
Name of the outcome measure(*) : Phase III: Time to local relapse
Description of the outcome measure : difference between the date of randomization and the date of observation of local relapse (LR), or the date of last observation if no LR occurred (censored observation)
Type of the outcome measure : Primary
Time point(s) of assessment : From the date of randomization until the date of observation of local relapse or the date of last observation if no LR occurred, whichever came first (assessed up to 26 months)
Name of the outcome measure(*) : Disease-free survival
Description of the outcome measure : Disease-free survival
Type of the outcome measure : Secondary
Time point(s) of assessment : up to 26 months
Name of the outcome measure(*) : Distant-metastasis-free survival
Description of the outcome measure : Distant-metastasis-free survival
Type of the outcome measure : Secondary
Time point(s) of assessment : through study completion, an average of 26 months
Name of the outcome measure(*) : Overall survival (OS)
Description of the outcome measure : Overall survival (OS)
Type of the outcome measure : Secondary
Time point(s) of assessment : up to 26 months
Name of the outcome measure(*) : Cause of death (tumor-related, not tumor-related)
Description of the outcome measure : Cause of death (tumor-related, not tumor-related)
Type of the outcome measure : Secondary
Time point(s) of assessment : through study completion, an average of 26 months
Name of the outcome measure(*) : Acute toxicity according to Common Terminology Criteria (CTC) version 5.0
Description of the outcome measure : Acute toxicity according to Common Terminology Criteria (CTC) version 5.0
Type of the outcome measure : Secondary
Time point(s) of assessment : up to 2 months
Name of the outcome measure(*) : Late toxicity according to CTC version 5.0
Description of the outcome measure : Late toxicity according to CTC version 5.0
Type of the outcome measure : Secondary
Time point(s) of assessment : up to 24 months
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : No, there is no plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not specified
Masking of intervention(s) assignment
Masking implemented? : Not specified
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

Annotated Properties

Topic annotations

Preclinical and clinical studies

De-Intensification of Postoperative Radiotherapy in Patients with Squamous Cell Carcinoma of the Head and Neck (DIREKHT2)

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