Head and Neck CarcinomaTRAINNCT04655469
Personal Health Train for Radiation Oncology in India and The Netherlands
An observational study of Head and Neck Carcinoma, run by Maastricht Radiation Oncology at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- How many people
- 2,000 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Apr 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
India2 sites
Healthcare Global
Bengaluru, Karnataka, 560020
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
About this study
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.
Read the detailed description
"Big data analytics in cancer care holds immense potential to unlock valuable clinical insights from an abundance of patient medical records, aided by sophisticated statistical models, that will lead to improved population-based outcomes and deeper personalization of cancer treatment. However, the clinical data (which includes medical images, clinical examinations and laboratory results) has been locked away in disconnected "silos" within every clinic. Additionally, patient information is exceedingly sensitive to privacy issues and confidentiality breaches.
The investigators have pioneered the innovative Personal Health Train approach, whereby support for choosing the best treatment (i.e. decision support) is accessible without any patient records ever leaving the clinic of origin. This extends our current work on an extensible data architecture to learn from quantitative imaging data in India and The Netherlands (without images being taken out of the clinic) - NWO/DeITy BIONIC. The investigators have now developed numerous models of clinical outcome after treatment, including those for undesirable side-effects of treatment. The investigators continue to lead big data integration work within multicenter clinical decision support projects such as KWF-ProTraIT and Horizon2020-BD2DECIDE.
The overall aim of the TRAIN project is to combine big data (including images, laboratory tests and clinical examinations) to improve the outcomes for head \& neck cancer patients in both India and The Netherlands. The investigators will do this by creating data-driven Decision Support Systems to predict which treatment gives the best outcome given individual patient characteristics, and local diagnostic and treatment capabilities. Cancer specialists in both countries will lead the design and clinical evaluation of this decision support system, which could be deployed in multiple clinics across all of the settings encountered in India and The Netherlands.
Head and neck cancer is a relatively rare condition in the Netherlands, such that the data volume available to learn from is much smaller than in India. Conversely, Indian patients typically present at a more advanced stage of cancer compared to Dutch patients. These differences in patients and treatments can be leveraged by machine learning algorithms to learn better predictive models. Decision support systems are essential, since guideline deviations in both countries are common due to individual patient characteristics, patient preferences and uneven distribution of treatment capacity outside major urban centers.
To achieve the above, The investigators first deploy the ICT infrastructure (in collaboration with Philips India) to connect local hospital information systems so that clinical, imaging and outcome data on head \& neck cancer patients becomes findable, accessible, interoperable and reusable (FAIR) big data. The investigators then deploy learning algorithms that traverse the big data repositories of each participating hospital, using the privacy-preserving Personal Health Train approach, to develop a decision support system. Cancer specialists in India and the Netherlands will jointly evaluate the clinical utility of the decision support system by means of a prospective randomized clinical trial."
- Conditions
- Head and Neck Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2 years
Secondary outcomes (3)
Recurrence
Measured: 2 years
Distant metastases
Measured: 2 years
Treatment-related adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start10 Apr 2020
- Primary completion15 May 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Dekker, Maastricht Radiation Oncology
- Investigators
- Andre Dekker, Prof.Dr.Ir., Principal investigator, Department: GROW School for Oncology and Developmental Biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655469
- Sponsor's protocol ID
- 629.002.212
- Acronym
- TRAIN
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2020
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Health Train for Radiation Oncology in India and The Netherlands
- ClinicalTrials.gov ID
- NCT04655469
- Acronym / sponsor ID
- TRAIN / 629.002.212
- Conditions
- Head and Neck Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
"Big data analytics in cancer care holds immense potential to unlock valuable clinical insights from an abundance of patient medical records, aided by sophisticated statistical models, that will lead to improved population-based outcomes and deeper personalization of cancer treatment. However, the clinical data (which includes medical images, clinical examinations and laboratory results) has been locked away in disconnected "silos" within every clinic. Additionally, patient information is exceedingly sensitive to privacy issues and confidentiality breaches.
The investigators have pioneered the innovative Personal Health Train approach, whereby support for choosing the best treatment (i.e. decision support) is accessible without any patient records ever leaving the clinic of origin. This extends our current work on an extensible data architecture to learn from quantitative imaging data in India and The Netherlands (without images being taken out of the clinic) - NWO/DeITy BIONIC. The investigators have now developed numerous models of clinical outcome after treatment, including those for undesirable side-effects of treatment. The investigators continue to lead big data integration work within multicenter clinical decision support projects such as KWF-ProTraIT and Horizon2020-BD2DECIDE.
The overall aim of the TRAIN project is to combine big data (including images, laboratory tests and clinical examinations) to improve the outcomes for head \& neck cancer patients in both India and The Netherlands. The investigators will do this by creating data-driven Decision Support Systems to predict which treatment gives the best outcome given individual patient characteristics, and local diagnostic and treatment capabilities. Cancer specialists in both countries will lead the design and clinical evaluation of this decision support system, which could be deployed in multiple clinics across all of the settings encountered in India and The Netherlands.
Head and neck cancer is a relatively rare condition in the Netherlands, such that the data volume available to learn from is much smaller than in India. Conversely, Indian patients typically present at a more advanced stage of cancer compared to Dutch patients. These differences in patients and treatments can be leveraged by machine learning algorithms to learn better predictive models. Decision support systems are essential, since guideline deviations in both countries are common due to individual patient characteristics, patient preferences and uneven distribution of treatment capacity outside major urban centers.
To achieve the above, The investigators first deploy the ICT infrastructure (in collaboration with Philips India) to connect local hospital information systems so that clinical, imaging and outcome data on head \& neck cancer patients becomes findable, accessible, interoperable and reusable (FAIR) big data. The investigators then deploy learning algorithms that traverse the big data repositories of each participating hospital, using the privacy-preserving Personal Health Train approach, to develop a decision support system. Cancer specialists in India and the Netherlands will jointly evaluate the clinical utility of the decision support system by means of a prospective randomized clinical trial."
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 2 years
3 secondary outcomes
Recurrence
Time frame: 2 years
Distant metastases
Time frame: 2 years
Treatment-related adverse events
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre Dekker, Prof.Dr.Ir. principal investigator
Department: GROW School for Oncology and Developmental Biology
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Carcinoma, run by Maastricht Radiation Oncology at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.