Standard Follow-up Program (SFP) for Head and Neck Cancer Patients

NCT02435576 | Recruiting

• 1 other identifier: SFP2007-03
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

The primary and general objective of the clinical introduction of the 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

Acute toxicity; Late toxicity; NTCP models; Proton therapy; Patient-rated outcomes; Quality of life

Outcome Measures

Primary Outcomes (1)

• Late toxicity

  Late toxicity

  At 6 months after last day of completion of treatment

Secondary Outcomes (14)

• Change in acute toxicity

  At 1,2,3,4,5,6,7 (= during radiation therapy) and 12 weeks (= 6 weeks after completion of treatment) after first day of radiation therapy

• Change in patient-rated quality of life

  At 6,12,18,24,36,48,60 months after completion of treatment

• Overall survival

  At 1,2,3,4 and 5 years after completion of treatment

• Change in locoregional tumour control

  At 1,2,3,4 and 5 years after completion of treatment

• Laryngo-oesophageal dysfunction-free survival

  At 1,2,3,4 and 5 years after completion of treatment

Interventions

Radiotherapy (primary or postoperative) RADIATION

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

All patients with head and neck cancer planned for curatively intended primary or postoperative radiotherapy will be included.

You may qualify if:

• All patients planned for curatively intended primary or postoperative radiotherapy will be included. At the first visit, patients are informed about the standard follow up program by the treating physician.

You may not qualify if:

• All patients planned for palliative radiotherapy will not be included in the SFP.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiotherapy; Postoperative Period

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• J.A. Langendijk, Prof. Dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J.A. Langendijk, Prof. Dr.

CONTACT

+31503615532; j.a.langendijk@umcg.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: March 27, 2015
• First Posted: May 6, 2015
• Study Start: March 1, 2007
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)