Outcome Prediction in Head&Neck Cancer Patients After Radiotherapy

NCT01985984 | Recruiting DMC

• 1 other identifier: 12-02-8/02-extern-6820
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Head and neck cancer

Outcome Measures

Primary Outcomes (1)

• overall survival

  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.

  5 years

Secondary Outcomes (2)

• disease free survival

  5 years

• loco-regional control

  5 years

Other Outcomes (2)

• Patient-rated symptoms and quality of life

  5 years

• Acute and late toxicity scores, according to CTCv4.0 criteria

  5 years

Study Arms (1)

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: Radiation in combination with systemic therapy

Interventions

Radiation alone RADIATION

Radiation alone

H&N cancer patients

Radiation in combination with systemic therapy RADIATION

Radiation in combination with systemic therapy

Also known as: Chemoradiation

H&N cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• All patients planned for curatively intended primary or postoperative radiotherapy

You may not qualify if:

• All patients planned for palliative radiotherapy

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

Maastro Clinic

Maastricht, Netherlands

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiation; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Physical Phenomena; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• F Hoebers, MD, PhD

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

F Hoebers, MD, PhD

CONTACT

+31884455666; frank.hoebers@maastro.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: July 1, 2012
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)