Outcome Prediction in Head&Neck Cancer Patients After Radiotherapy Patients (OutcomeH&N)
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|ClinicalTrials.gov Identifier: NCT01985984|
Recruitment Status : Recruiting
First Posted : November 18, 2013
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Radiation: Radiation alone Radiation: Radiation in combination with systemic therapy|
For head and neck squamous cell carcinoma (HNSCC), radiation therapy is one of the mainstays of therapy either as definitive therapy alone or in combination with systemic therapy or following surgical resection as postoperative treatment. Nowadays there's great attention for personalized medicine which aims at offering a patient the treatment that best suits the individual patient and its tumor characteristics. To apply personalized therapy, we need accurate outcome prediction models for disease control, treatment related toxicity and quality of life.
The main factors used for predictive/prognostic nomograms are clinical factors, like patient-, tumor- and treatment related factors (1). Standard examples of these include age, gender, co-morbidity, smoking history, hemoglobin levels, tumor site, TNM stage, tumor volume, HPV-status, and others. For larynx cancer the nomogram was made publicly available on www.predictcancer.org.
However, we anticipate that other factors will contribute to the (improvement of) prediction models. These factors may include genomic analysis of tumor specimens, quantitative image analysis (radiomics), blood biomarkers, and/or tumor-tissue markers (2).
In addition, treatment-related parameters also need to be considered and these not only include factors like overall treatment time, use of systemic therapy, prescribed radiation dose and fraction dose. With new techniques using EPID dosimetry, it is now possible to measure the delivered radiation dose and compare this to the prescribed dose (3,4). This offers the potential to apply Dose Guide RadioTherapy (DGRT), which especially in HNSCC may have a large impact, because anatomical changes during fractionated therapy are known to occur and lead to dose changes to targets and organs at risk (5,6).
The final objective of this study is to integrate all potential prognostic factors and develop reliable nomograms both for tumor control as well as complications.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Outcome Prediction in Head&Neck Cancer Patients After Radiotherapy Using Multi-parameter Modelling: Disease Control, Toxicity and Quality of Life|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2023|
H&N cancer patients
Patients with Head and Neck Cancer, treated with curative intent
Radiation: Radiation alone
Radiation: Radiation in combination with systemic therapy
Radiation in combination with systemic therapy
Other Name: Chemoradiation
- overall survival [ Time Frame: 5 years ]The overall survival will be calculated from the first day of treatment, either the first day of induction chemotherapy or the first day of radiotherapy in case of concomitant chemoradiation or radiation alone. An event is defined as death of any cause.
- disease free survival [ Time Frame: 5 years ]
- loco-regional control [ Time Frame: 5 years ]Loco-regional control will be calculated from the first day of treatment, either the first day of induction chemotherapy or the first day of radiotherapy in case of concomitant chemoradiation or radiation alone. An event is defined as local recurrence and/or regional recurrence. These two events will be separately scored.
- Patient-rated symptoms and quality of life [ Time Frame: 5 years ]quality of life (EORTC QLQ-C30, EORTC QLQ-H&N35, EuroQoL-EQ5D)
- Acute and late toxicity scores, according to CTCv4.0 criteria [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985984
|Contact: F Hoebers, MD, PhDfirstname.lastname@example.org|
|Contact: Ph Lambin, prof Dr|
|Principal Investigator: Frank Hoebers, Dr.|
|Principal Investigator:||F Hoebers, MD, PhD||Maastro Clinic, The Netherlands|