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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
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Brief Summary:
The primary and general objective of the clinical introduction of the Standard Follow-up Program (SFP) as the current standard of care is to improve the quality of radiotherapy for head and neck cancer patients by reducing radiation-induced side effects without hampering treatment efficacy in terms of locoregional tumour control and overall survival and to systematically evaluate the beneficial effect of newly introduced radiation technology for this particular group of patients. The clinical introduction of the SFP will allow for a systematic and broad scale quality improvement cycle for head and neck cancer patients treated with radiotherapy. In fact, this methodology can be considered a kind of quality circle for the clinical introduction of new radiation techniques, aiming at continuous efforts for further improvement.

Condition or disease Intervention/treatment
Head and Neck Cancer Radiation: Radiation alone Radiation: Radiation in combination with systemic therapy

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
H&N cancer patients

Patients with Head and Neck Cancer, treated with curative intent

  • Any tumor site
  • Stage I-IV, M0
  • Treated with radiotherapy alone or in combination with systemic therapy
  • Definitive radiotherapy or postoperative radiotherapy

Interventions:

  • Radiation alone
  • Radiation in combination with systemic therapy
Radiation: Radiation alone
Radiation alone

Radiation: Radiation in combination with systemic therapy
Radiation in combination with systemic therapy
Other Name: Chemoradiation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. disease free survival [ Time Frame: 5 years ]
  2. 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.


Other Outcome Measures:
  1. Patient-rated symptoms and quality of life [ Time Frame: 5 years ]
    quality of life (EORTC QLQ-C30, EORTC QLQ-H&N35, EuroQoL-EQ5D)

  2. Acute and late toxicity scores, according to CTCv4.0 criteria [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Characteristics of the population:

  • Patients with Head and Neck Cancer, treated with curative intent
  • Any tumor site
  • Stage I-IV, M0
  • Treated with radiotherapy alone or in combination with systemic therapy
  • Definitive radiotherapy or postoperative radiotherapy
Criteria

Inclusion Criteria:

All patients planned for curatively intended primary or postoperative radiotherapy

Exclusion Criteria:

All patients planned for palliative radiotherapy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985984


Contacts
Contact: F Hoebers, MD, PhD +31884455666 frank.hoebers@maastro.nl

Locations
Netherlands
Maastro Clinic Recruiting
Maastricht, Netherlands
Contact: Ph Lambin, prof Dr         
Principal Investigator: Frank Hoebers, Dr.         
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Principal Investigator: F Hoebers, MD, PhD Maastro Clinic, The Netherlands

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01985984     History of Changes
Other Study ID Numbers: 12-02-8/02-extern-6820
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maastricht Radiation Oncology:
Head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms