Personal Health Train for Radiation Oncology in India and The Netherlands

NCT04655469 | Active Not Recruiting

• 1 other identifier: 629.002.212
• Study Type: observational
• Target: 2,000
• Locations: 2 countries
• Sites: 3

Brief Summary

The primary and general objective of this protocol as the current standard of care is to improve the quality of radiotherapy for HNC patients. This will ultimately be achieved by optimizing locoregional tumour control and overall survival and by reducing radiation-induced side effects. It will also allow the assessment of the effects of newly introduced radiation technology (e.g. proton therapy) for this particular group of patients. The clinical introduction of this standard follow-up program (SFP) will allow for a systematic and broad scale quality improvement cycle for HNC patients treated with radiotherapy.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2 years

Secondary Outcomes (3)

• Recurrence

  2 years

• Distant metastases

  2 years

• Treatment-related adverse events

  2 years

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

This UMBRELLA protocol can be used for any patient with HNC that is scheduled for curative intent primary or postoperative radiotherapy with or without systemic therapy. It is to be used prospectively for new patients entering the clinic. Inclusion in clinical trials is not an exclusion criterion. It is possible to add additional assessments required for the clinical study.

You may qualify if:

• Histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC)
• Head and Neck primary tumor site: oral cavity, oropharynx, larynx or hypopharynx
• Treated between 01-2008 and 12-2017
• Clinical stage III and IV (a, b) according to TNM 7th edition
• No distant metastases (M0)
• Treated with curative intent: primary definitive radiation therapy with or without systemic treatment
• Availability of baseline imaging:
• Planning CT scan of the HN region in treatment position, with RT-structures available, performed with contiguous cuts of 2-3 mm or less in slice thickness with i.v. contrast
• (if available) FDG-PET in treatment position

You may not qualify if:

• Any previous HNC
• Patients with previous malignancies in the last 5 years before treatment for HNC, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin
• Any previous malignancy that was treated with surgery and/or radiation of the head and neck region
• Histological type other than HNSCC
• Cancers originating in the oral cavity, nasopharynx, salivary glands or sinonasal area
• Postoperative radiation treatment setting

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (3)

Healthcare Global

Bengaluru, Karnataka, 560020, India

Location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Maastro

Maastricht, Limburg, 6229 ET, Netherlands

Location

Study Officials

• Andre Dekker, Prof.Dr.Ir.

  Department: GROW School for Oncology and Developmental Biology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Data Science

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: December 7, 2020
• Study Start: April 10, 2020
• Primary Completion: May 15, 2024
• Study Completion: December 31, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

NL (1); IN (2)