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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 February 2016 |
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Main ID: |
NCT02242916 |
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Date of registration:
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15/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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State of the Art Photon Therapy Versus Particle Therapy for Recurrent Head & Neck Tumors; a Planning Study
ROCOCO |
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Scientific title:
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In Silico Clinical Trial, Comparing State of the Art Photon Modalities With Proton and C-ion Therapy for Recurrent Head & Neck Tumors: A Multicentric Planning Study From the ROCOCO (Radiation Oncology COllaborative COmparison) Group |
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Date of first enrolment:
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May 2014 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02242916 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Retrospective
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Danielle Eekers, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maastro Clinic, Dr Tanslaan 12, Maastricht, The Netherlands |
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Name:
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Philippe lambin, prof, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maastro Clinic, Dr Tanslaan 12, Maastricht, The Netherlands |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Primary treatment:
1. = 50 Gy with curative intent (with or without chemo)
2. CTV includes primary tumor and at least level II-IV
3. Severe dental scatter artifacts or metal implants of unknown density will be
excluded
4. IMRT plan available
- Secondary treatment after = 1 year, dose 70 Gy
a. Severe dental scatter artifacts or metal implants of unknown density will be
excluded
- Overlap of at least one OAR in primary and secondary treatment
Exclusion Criteria:
- Patients referred for postoperative radiotherapy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carcinoma, Squamous Cell of Head and Neck
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Intervention(s)
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Radiation: Photon therapy versus proton therapy
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Radiation: Photon therapy versus C-ion therapy
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Primary Outcome(s)
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Radiation exposure for organs at risk in H&N cancer patients
[Time Frame: 7 weeks]
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Secondary Outcome(s)
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Normal tissue complication probability (NTCP) for a fixed tumor dose
[Time Frame: 3 years]
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Secondary ID(s)
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ROCOCO re-irradiation HN
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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