Head and Neck NeoplasmsROCOCONCT02908386
ROCOCO - Adaptive IMRT Versus IMPT in Head and Neck Cancer
An observational study of Head and Neck Neoplasms, run by Maastricht Radiation Oncology at 1 site in United States.
Trial summary
Given the lack of evidence for the benefit of particle therapy in relevant cases, he investigators proposed an in silico trial to investigate the dosimetric effect of contour changes for OAR as well as tumor during chemoradiation in H\&N patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Nov 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of 10 consecutive patients treated with proton therapy at the University of Pennsylvania (USA). Other treatment modalities for the tumor sites, such as chemotherapy will not be taken into account. Included are H\&N patients who have been treated with radical intent. Each patient will function as his or her own control.
Who may be able to join
- patients with head and neck carcinoma who have been treated with radical intent 10 patients, all with a reference CT scan and CT scans at 7 time points during treatment.
Who cannot join
- patients with no head and neck cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: In Silico Clinical Trial on Adaptive Radiotherapy in Oropharynx Cancer, Comparing Photon & Proton Therapy: A Multicentric ROCOCO Planning Study Based on a Reference Dataset.
Given the lack of evidence for the benefit of particle therapy in relevant cases, he investigators proposed an in silico trial to investigate the dosimetric effect of contour changes for OAR as well as tumor during chemoradiation in H\&N patients. Photon and proton-therapy will be compared based on dosimetric data on 7 time points during treatment combined with plan robustness. In that way the investigators will be able to assess and compare the optimal timing for replanning for photon and proton therapy.
A database of the University of Pennsylvania (Upenn) consists of 10 patients with head and neck tumors treated with chemo-radiation. Contrast-enhanced CT scans were acquired prior and during RT (T1-T7)
Read the detailed description
Given that the cost of particle therapy (PT) is considerably higher than that of conventional radiotherapy (RT) with photons, it is necessary to establish whether these higher costs are worthwhile in light of the expected advantages. Thus, clear evidence of the situations in which PT outperforms conventional photon treatment is needed. ROCOCO (Radiation Oncology COllaborative Comparison) is commenced at MAASTRO in May 2007 to evaluate PT's cost-effectiveness .
It is well known that during radiation treatment of head and neck cancer (HN), shrinkage and displacement of tumour and organs at risk (OARs, e.g. parotid glands), as well as weight loss may cause significant radiation dose changes to target volumes and organs at risk , , . These phenomena may cause the necessity to re-plan the treatment at a certain moment in time. In the last years many different treatment planning studies have been performed showing that the optimum moment for re-planning varies: after 20 Gy, 35 or 46 Gy. But what the actual effect of the deformation is on dose in actually treated patients has not been reported.
The investigators propose an in silico trial to investigate the relevance of contour changes for OAR as well as tumor during chemo radiation in H\&N patients which will eventually lead to replanning. In that way the investigators will be able to assess and compare the optimal timing for replanning for photon and proton therapy.
The investigators compare different treatments focusing on the effect of deformation on PTV coverage and normal tissue radiation exposure. A fixed tumor dose, using the same delineation of gross target volume (GTV), clinical target volume (CTV) is used. The planning target volume (PTV) will be determined by each treatment modality.
For the initial plan the best possible dose distribution will be determined using the planning-CT (reference scan). For every time point (CT-scan) the reference treatment plan will be projected on the actual CT scan and the dose will be recalculated without changing the treatment parameters. This will be done using both photons and protons. All treatment uncertainties including robustness will be taken into account. Dose differences in the target volume (CTV-GTV and PTV) and the OAR, as a result of tumor shrinkage during treatment will be evaluated for each time point and each treatment modality.
The objective of this study is to assess plan robustness and the optimal timing for replanning for photon and proton therapy.
- Conditions
- Head and Neck Neoplasms
- Keywords
- Head and neck tumors, Proton, Photon, replanning timing
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose distribution
Dose values of seven time frames (T1-T7) are compared to the reference dose values on the planning CT for both photon and proton treatment plans.
Measured: up to 26 weeks
Secondary outcomes (1)
Optimal timing for replanning
Determine the optimal timing for replanning for each modality when taking all the treatment uncertainties in account.
Measured: up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2016 (estimated)
- Study completionNov 2016 (estimated)
Why it stopped: At the moment no participants are enrolled untill a new agreement is made
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Philippe Lambin, Prof dr, Study director, Maastro Clinic, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908386
- Sponsor's protocol ID
- 2016 ROCOCO HN
- Acronym
- ROCOCO
- Status last verified
- Sep 2016
- First submitted
- 13 Apr 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Roelofs E, Engelsman M, Rasch C, Persoon L, Qamhiyeh S, de Ruysscher D, Verhaegen F, Pijls-Johannesma M, Lambin P; ROCOCO Consortium. Results of a multicentric in silico clinical trial (ROCOCO): comparing radiotherapy with photons and protons for non-small cell lung cancer. J Thorac Oncol. 2012 Jan;7(1):165-76. doi: 10.1097/JTO.0b013e31823529fc.
PubMed 22071782Barker JL Jr, Garden AS, Ang KK, O'Daniel JC, Wang H, Court LE, Morrison WH, Rosenthal DI, Chao KS, Tucker SL, Mohan R, Dong L. Quantification of volumetric and geometric changes occurring during fractionated radiotherapy for head-and-neck cancer using an integrated CT/linear accelerator system. Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):960-70. doi: 10.1016/j.ijrobp.2003.12.024.
PubMed 15234029Ricchetti F, Wu B, McNutt T, Wong J, Forastiere A, Marur S, Starmer H, Sanguineti G. Volumetric change of selected organs at risk during IMRT for oropharyngeal cancer. Int J Radiat Oncol Biol Phys. 2011 May 1;80(1):161-8. doi: 10.1016/j.ijrobp.2010.01.071. Epub 2010 Nov 19.
PubMed 21306971Geets X, Tomsej M, Lee JA, Duprez T, Coche E, Cosnard G, Lonneux M, Gregoire V. Adaptive biological image-guided IMRT with anatomic and functional imaging in pharyngo-laryngeal tumors: impact on target volume delineation and dose distribution using helical tomotherapy. Radiother Oncol. 2007 Oct;85(1):105-15. doi: 10.1016/j.radonc.2007.05.010. Epub 2007 Jun 11.
PubMed 17562346
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Silico Clinical Trial on Adaptive Radiotherapy in Oropharynx Cancer, Comparing Photon & Proton Therapy: A Multicentric ROCOCO Planning Study Based on a Reference Dataset.
- ClinicalTrials.gov ID
- NCT02908386
- Acronym / sponsor ID
- ROCOCO / 2016 ROCOCO HN
- Conditions
- Head and Neck Neoplasms
- Keywords
- Head and neck tumors, Proton, Photon, replanning timing
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: At the moment no participants are enrolled untill a new agreement is made
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 21 Sep 2016 (estimated)
- 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.
Given the lack of evidence for the benefit of particle therapy in relevant cases, he investigators proposed an in silico trial to investigate the dosimetric effect of contour changes for OAR as well as tumor during chemoradiation in H\&N patients. Photon and proton-therapy will be compared based on dosimetric data on 7 time points during treatment combined with plan robustness. In that way the investigators will be able to assess and compare the optimal timing for replanning for photon and proton therapy.
A database of the University of Pennsylvania (Upenn) consists of 10 patients with head and neck tumors treated with chemo-radiation. Contrast-enhanced CT scans were acquired prior and during RT (T1-T7)
Detailed description
Given that the cost of particle therapy (PT) is considerably higher than that of conventional radiotherapy (RT) with photons, it is necessary to establish whether these higher costs are worthwhile in light of the expected advantages. Thus, clear evidence of the situations in which PT outperforms conventional photon treatment is needed. ROCOCO (Radiation Oncology COllaborative Comparison) is commenced at MAASTRO in May 2007 to evaluate PT's cost-effectiveness .
It is well known that during radiation treatment of head and neck cancer (HN), shrinkage and displacement of tumour and organs at risk (OARs, e.g. parotid glands), as well as weight loss may cause significant radiation dose changes to target volumes and organs at risk , , . These phenomena may cause the necessity to re-plan the treatment at a certain moment in time. In the last years many different treatment planning studies have been performed showing that the optimum moment for re-planning varies: after 20 Gy, 35 or 46 Gy. But what the actual effect of the deformation is on dose in actually treated patients has not been reported.
The investigators propose an in silico trial to investigate the relevance of contour changes for OAR as well as tumor during chemo radiation in H\&N patients which will eventually lead to replanning. In that way the investigators will be able to assess and compare the optimal timing for replanning for photon and proton therapy.
The investigators compare different treatments focusing on the effect of deformation on PTV coverage and normal tissue radiation exposure. A fixed tumor dose, using the same delineation of gross target volume (GTV), clinical target volume (CTV) is used. The planning target volume (PTV) will be determined by each treatment modality.
For the initial plan the best possible dose distribution will be determined using the planning-CT (reference scan). For every time point (CT-scan) the reference treatment plan will be projected on the actual CT scan and the dose will be recalculated without changing the treatment parameters. This will be done using both photons and protons. All treatment uncertainties including robustness will be taken into account. Dose differences in the target volume (CTV-GTV and PTV) and the OAR, as a result of tumor shrinkage during treatment will be evaluated for each time point and each treatment modality.
The objective of this study is to assess plan robustness and the optimal timing for replanning for photon and proton therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 10 consecutive patients treated with proton therapy at the University of Pennsylvania (USA). Other treatment modalities for the tumor sites, such as chemotherapy will not be taken into account. Included are H\&N patients who have been treated with radical intent. Each patient will function as his or her own control.
Key inclusion criteria (1 listed)
- patients with head and neck carcinoma who have been treated with radical intent 10 patients, all with a reference CT scan and CT scans at 7 time points during treatment.
Key exclusion criteria (1 listed)
- patients with no head and neck cancer
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
Dose distribution
Time frame: up to 26 weeks
Dose values of seven time frames (T1-T7) are compared to the reference dose values on the planning CT for both photon and proton treatment plans.
1 secondary outcome
Optimal timing for replanning
Time frame: up to 26 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Results publication: PubMed 22071782Roelofs E, Engelsman M, Rasch C, Persoon L, Qamhiyeh S, de Ruysscher D, Verhaegen F, Pijls-Johannesma M, Lambin P; ROCOCO Consortium. Results of a multicentric in silico clinical trial (ROCOCO): comparing radiotherapy with photons and protons for non-small cell lung cancer. J Thorac Oncol. 2012 Jan;7(1):165-76. doi: 10.1097/JTO.0b013e31823529fc.
- Results publication: PubMed 15234029Barker JL Jr, Garden AS, Ang KK, O'Daniel JC, Wang H, Court LE, Morrison WH, Rosenthal DI, Chao KS, Tucker SL, Mohan R, Dong L. Quantification of volumetric and geometric changes occurring during fractionated radiotherapy for head-and-neck cancer using an integrated CT/linear accelerator system. Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):960-70. doi: 10.1016/j.ijrobp.2003.12.024.
- Results publication: PubMed 21306971Ricchetti F, Wu B, McNutt T, Wong J, Forastiere A, Marur S, Starmer H, Sanguineti G. Volumetric change of selected organs at risk during IMRT for oropharyngeal cancer. Int J Radiat Oncol Biol Phys. 2011 May 1;80(1):161-8. doi: 10.1016/j.ijrobp.2010.01.071. Epub 2010 Nov 19.
- Results publication: PubMed 17562346Geets X, Tomsej M, Lee JA, Duprez T, Coche E, Cosnard G, Lonneux M, Gregoire V. Adaptive biological image-guided IMRT with anatomic and functional imaging in pharyngo-laryngeal tumors: impact on target volume delineation and dose distribution using helical tomotherapy. Radiother Oncol. 2007 Oct;85(1):105-15. doi: 10.1016/j.radonc.2007.05.010. Epub 2007 Jun 11.
- Individual participant dataSharing planned: Yes
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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.
Philippe Lambin, Prof dr study director
Maastro Clinic, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms, run by Maastricht Radiation Oncology at 1 site in United States.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Dose distribution (time frame: up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02908386, which also lists 4 linked publications.
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 21 Sep 2016.