Evaluation of lymph node response with 3D-FSE CUBE imaging during chemoradiotherapy treatment of patients with head and neck squamous cell carcinoma.

Evaluation of lymph node response with 3D-FSE CUBE imaging during chemoradiotherapy treatment of patients with head and neck squamous cell carcinoma. - EVALYM:Lymph nodes response during (chemo)radiation.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37180

Enrollment

Registered

2012-08-30

Start date

2012-09-15

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oncologie in hoofd/halsgebied Head and neck tumor Squamous cell carcinoma of the head and neck region including the oral cavity pharynx and larynx

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients with untreated primary squamous cell carcinomas of pharynx, the oral cavity, and larynx with proven metastases in cervical lymph nodes. - Scheduled for (chemo)radiotherapy with curative intention. - Signed informed consent.

Exclusion criteria

Exclusion criteria: carcinoma. -Patients undergoing any other treatment option like surgery for lymph node metastasis. -Patients with other types of head and neck malignancies: lymphatic neoplasms, esophageal malignancies, thyroid cancer, lip cancer, skin cancers and other malignancies not originating from the pharynx, laryngeal or oral cavity epithelial origin. -Having any physical or mental status that interferes with the informed consent procedure. -Contraindications for MRI (e.g. claustrophobia, arterial clips in central nervous system)

Design outcomes

Primary

Measure	Time frame
Lymph nodes will be divided in a benign (1cm smallest axis and/or positive cytology) group. Volume change (absolute and relative) per lymph node and per patient will be calculated with a confidence interval of 95%. Treatment response is defined as a decrease in volume > 50%. Predictive value of volume decrease during (chemo)radiotherapy is defined as sensitivity, specificity, positive and negative predictive value of volume change. A ROC curve will be constructed on the basis of volume decrease between baseline and two weeks. By defining an optimal area under the curve (AUC) the optimal cut-off value of volume decrease for prediction of treatment response can be estimated.	—

Measure

Time frame

Lymph nodes will be divided in a benign (1cm smallest axis and/or positive cytology) group. Volume change (absolute and relative) per lymph node and per patient will be calculated with a confidence interval of 95%. Treatment response is defined as a decrease in volume > 50%. Predictive value of volume decrease during (chemo)radiotherapy is defined as sensitivity, specificity, positive and negative predictive value of volume change. A ROC curve will be constructed on the basis of volume decrease between baseline and two weeks. By defining an optimal area under the curve (AUC) the optimal cut-off value of volume decrease for prediction of treatment response can be estimated.

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Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results