Carcinoma, Squamous Cell of Head and NeckROCOCONCT02242916
State of the Art Photon Therapy Versus Particle Therapy for Recurrent Head & Neck Tumors; a Planning Study
An observational study of Carcinoma, Squamous Cell of Head and Neck, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
Given that the cost of proton therapy is considerably higher than that of conventional radiotherapy with photons, it is necessary to establish whether these higher costs are worthwhile in light of the expected advantages2,3,4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell of Head and Neck
- What is being tested?
- Photon therapy versus proton therapy and Photon therapy versus C-ion therapy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2014to Oct 2015
- 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: patients with recurrent head and neck tumors
Who may be able to join
- Primary treatment:
- ≥ 50 Gy with curative intent (with or without chemo)
- CTV includes primary tumor and at least level II-IV
- Severe dental scatter artifacts or metal implants of unknown density will be excluded
- IMRT plan available
- Secondary treatment after ≥ 1 year, dose 70 Gy
- Severe dental scatter artifacts or metal implants of unknown density will be excluded
- Overlap of at least one OAR in primary and secondary treatment
Who cannot join
- Patients referred for postoperative radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Given that the cost of proton therapy is considerably higher than that of conventional radiotherapy with photons, it is necessary to establish whether these higher costs are worthwhile in light of the expected advantages2,3,4. Thus, clear evidence of the situations in which proton therapy outperforms conventional photon treatment is needed. The investigators therefore aim to demonstrate through an in silico trial that proton therapy decrease the amount of irradiated normal tissue and, consequently, the risk of side effects in the surrounding normal tissue as well as the risk of secondary tumors. The same overall treatment time and an equal number of fractions will be used for both treatment modalities wherever possible. The most optimal technique for each individual patient, based on objective criteria related to limiting dose to normal tissue, will be prescribed by the institution concerned for each treatment option.
Read the detailed description
The CTV to PTV margin will be determined by the individual institutes according to the treatment technique and treatment modality. For all treatment plans, modified ICRU 50 will be applied. The ICRU 50 recommendation is that 100% of the target volume (PTV) receives at least 95% of the prescribed dose. In this work, participants agree that D98 > = 95%, D2 < = 107%, cold (< 95%) and hot (> 107%) spots should be avoided in general, and that no hot spots will be allowed outside the PTV. The same overall treatment time (OTT) and an equal number of fractions will be used for all treatment modalities.
Treatment plans will be carried out using either photons, protons and C-ions for dose calculation for the indication H\&N re-irradiation. A multicentric patient dataset, which can be found on a secured website5,6, will be used. The output databases with matrices including 3D delineation, the deliverable physical dose, RBE map, and BED/ EQD2 will be made available. To guarantee a similar set-up between the three treatments, similar dose distributions will be used. For C-ion treatment planning, a 20% uncertainty in the RBE values will be taken into account.
All treatment plans will be performed in centers that are already operating and have experience in treatment planning. Photon treatment plans will be carried out in Nijmegen en Maastricht, proton treatment plans at the University of Pennsylvania (UPENN) and the C-ion treatment plans at the University Hospital Marburg (UHM). For photons, all primary treatment plans were performed according to the planning procedure of each individual participating center by selecting the best available technique. The secondary photon treatment plan will be performed according predefined fractionation schedule and tumor dose. The proton treatment plans for H\&N tumors will be planned with active beam delivery using IMPT and/or passive 4D beam delivery (PSPT). The C-ion treatment plans will be planned using a raster-scanning technique (IMIT).
All relevant OAR are delineated in the primary and secondary study set. GTV/CTV will be used accordingly to the actual treatment. New DVH's will be calculated for the added OAR. The secondary plan (i.e. re-irradiation plan) will be calculated again for the best currently available options for Photon, proton and C-ions. Between primary and secondary treatment there is a period of 1 to 5 years for all patients. To be on the save site a 30 % recovery of brainstem and spinal cord is assumed. There will not be a correction for fraction size. For practical reasons the location of the Dmax in the brainstem or spinal cord will not be taken into account. A maximal cumulative dose of 120 Gy will be accepted in the mandibular.
If the mandibular is part of the CTV in the first as well as in the second treatment, a higher dose will be accepted. A cumulative dose of max 120 Gy will also be accepted for the larynx , for the arytenoid is this 100Gy, unless the larynx is within the CTV for the first and second treatment than a higher dose will be accepted.
This means that for a total study population of 25 patients per tumor site and group at least 100 treatment plans will be carried out. All dose maps will be saved on the secure website as part of the database mentioned above.
Photon, proton and C-ion treatments will be compared based on dosimetric parameters on normal tissues such as mean parotic dose, etc. In addition, the NTCP for a fixed tumor dose or the same expected TCP will be determined. Cobalt Gy equivalent doses will be used when reporting the proton and C-ion dose. In the case of protons, a constant RBE value of 1.1 will be used for both the tumor and the normal tissues. The RBE of C-ions will be calculated based on the models used by the participating centers. The GSI in-house treatment planning system uses RBE values calculated on the basis of the local effect model (LEM). The LEM I (alpha/beta=2) is based on the radial dose distribution of each charged particle crossing into a cell nucleus, as well as on the radiosensitivity and repair capacity of the tissue. The TPSs used by UHM is also based on the LEM model. The model used at NIRS utilizes fixed RBE values that are dependent on the depth in the body, but independent of dose level or tumor type.
- Being tested
- Photon therapy versus proton therapy, Photon therapy versus C-ion therapy
- Keywords
- reccurent Head and Neck tumors, re-irradiation, photon, proton, carbon-ion
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon therapy versus proton therapyRadiation
Photon therapy versus C-ion therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Patients with recurrent HN tumors | Patients with recurrent Head and Neck tumors Receives: Radiation: Photon therapy versus proton therapy; Radiation: Photon therapy versus C-ion therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation exposure for organs at risk in H&N cancer patients
Radiation exposure for organs at risk in H\&N patients treated with radiotherapy for recurrent tumors after primary radiotherapy. Results are based on in silico planning study which compares photon, proton and Carbon-ion treatments. The same biological radiation dose, fractionation schedule and tumor dose inhomogeneity is used. A wide range of OAR is included in this study, to be able to document doses to organs that are further away from the target volume, and also to quantify low doses to organs.
Measured: 7 weeks
Secondary outcomes (1)
Normal tissue complication probability (NTCP) for a fixed tumor dose
Based on the OAR radiation exposure, the Normal tissue complication probability (NTCP) for a fixed tumor dose or the same expected Tumor Control Probability (TCP) will be determined using dose response curves.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous Cell of Head and NeckStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Philipps University Marburg, University Medical Center Nijmegen
- Responsible party
- Sponsor
- Investigators
- Danielle Eekers, Dr., Principal investigator, Maastro Clinic, Dr Tanslaan 12, Maastricht, The NetherlandsPhilippe lambin, prof, Dr, Study director, Maastro Clinic, Dr Tanslaan 12, Maastricht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242916
- Sponsor's protocol ID
- ROCOCO re-irradiation HN
- Acronym
- ROCOCO
- Status last verified
- Jan 2016
- First submitted
- 15 Sep 2014
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02242916
- Acronym / sponsor ID
- ROCOCO / ROCOCO re-irradiation HN
- Keywords
- reccurent Head and Neck tumors, re-irradiation, photon, proton, carbon-ion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Philipps University Marburg, University Medical Center Nijmegen
- Study start
- May 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Sep 2014 (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 that the cost of proton therapy is considerably higher than that of conventional radiotherapy with photons, it is necessary to establish whether these higher costs are worthwhile in light of the expected advantages2,3,4. Thus, clear evidence of the situations in which proton therapy outperforms conventional photon treatment is needed. The investigators therefore aim to demonstrate through an in silico trial that proton therapy decrease the amount of irradiated normal tissue and, consequently, the risk of side effects in the surrounding normal tissue as well as the risk of secondary tumors. The same overall treatment time and an equal number of fractions will be used for both treatment modalities wherever possible. The most optimal technique for each individual patient, based on objective criteria related to limiting dose to normal tissue, will be prescribed by the institution concerned for each treatment option.
Detailed description
The CTV to PTV margin will be determined by the individual institutes according to the treatment technique and treatment modality. For all treatment plans, modified ICRU 50 will be applied. The ICRU 50 recommendation is that 100% of the target volume (PTV) receives at least 95% of the prescribed dose. In this work, participants agree that D98 > = 95%, D2 < = 107%, cold (< 95%) and hot (> 107%) spots should be avoided in general, and that no hot spots will be allowed outside the PTV. The same overall treatment time (OTT) and an equal number of fractions will be used for all treatment modalities.
Treatment plans will be carried out using either photons, protons and C-ions for dose calculation for the indication H\&N re-irradiation. A multicentric patient dataset, which can be found on a secured website5,6, will be used. The output databases with matrices including 3D delineation, the deliverable physical dose, RBE map, and BED/ EQD2 will be made available. To guarantee a similar set-up between the three treatments, similar dose distributions will be used. For C-ion treatment planning, a 20% uncertainty in the RBE values will be taken into account.
All treatment plans will be performed in centers that are already operating and have experience in treatment planning. Photon treatment plans will be carried out in Nijmegen en Maastricht, proton treatment plans at the University of Pennsylvania (UPENN) and the C-ion treatment plans at the University Hospital Marburg (UHM). For photons, all primary treatment plans were performed according to the planning procedure of each individual participating center by selecting the best available technique. The secondary photon treatment plan will be performed according predefined fractionation schedule and tumor dose. The proton treatment plans for H\&N tumors will be planned with active beam delivery using IMPT and/or passive 4D beam delivery (PSPT). The C-ion treatment plans will be planned using a raster-scanning technique (IMIT).
All relevant OAR are delineated in the primary and secondary study set. GTV/CTV will be used accordingly to the actual treatment. New DVH's will be calculated for the added OAR. The secondary plan (i.e. re-irradiation plan) will be calculated again for the best currently available options for Photon, proton and C-ions. Between primary and secondary treatment there is a period of 1 to 5 years for all patients. To be on the save site a 30 % recovery of brainstem and spinal cord is assumed. There will not be a correction for fraction size. For practical reasons the location of the Dmax in the brainstem or spinal cord will not be taken into account. A maximal cumulative dose of 120 Gy will be accepted in the mandibular.
If the mandibular is part of the CTV in the first as well as in the second treatment, a higher dose will be accepted. A cumulative dose of max 120 Gy will also be accepted for the larynx , for the arytenoid is this 100Gy, unless the larynx is within the CTV for the first and second treatment than a higher dose will be accepted.
This means that for a total study population of 25 patients per tumor site and group at least 100 treatment plans will be carried out. All dose maps will be saved on the secure website as part of the database mentioned above.
Photon, proton and C-ion treatments will be compared based on dosimetric parameters on normal tissues such as mean parotic dose, etc. In addition, the NTCP for a fixed tumor dose or the same expected TCP will be determined. Cobalt Gy equivalent doses will be used when reporting the proton and C-ion dose. In the case of protons, a constant RBE value of 1.1 will be used for both the tumor and the normal tissues. The RBE of C-ions will be calculated based on the models used by the participating centers. The GSI in-house treatment planning system uses RBE values calculated on the basis of the local effect model (LEM). The LEM I (alpha/beta=2) is based on the radial dose distribution of each charged particle crossing into a cell nucleus, as well as on the radiosensitivity and repair capacity of the tissue. The TPSs used by UHM is also based on the LEM model. The model used at NIRS utilizes fixed RBE values that are dependent on the depth in the body, but independent of dose level or tumor type.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with recurrent HN tumors | – | Radiation: Photon therapy versus proton therapy, Radiation: Photon therapy versus C-ion therapyPatients with recurrent Head and Neck tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with recurrent head and neck tumors
Key inclusion criteria (8 listed)
- Primary treatment:
- Secondary treatment after ≥ 1 year, dose 70 Gy
- Overlap of at least one OAR in primary and secondary treatment
Key exclusion criteria (1 listed)
- Patients referred for postoperative radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photon therapy versus proton therapy | Radiation | Patients with recurrent HN tumors |
| Photon therapy versus C-ion therapy | Radiation | Patients with recurrent HN tumors |
Primary outcome
Radiation exposure for organs at risk in H&N cancer patients
Time frame: 7 weeks
Radiation exposure for organs at risk in H\&N patients treated with radiotherapy for recurrent tumors after primary radiotherapy. Results are based on in silico planning study which compares photon, proton and Carbon-ion treatments. The same biological radiation dose, fractionation schedule and tumor dose inhomogeneity is used. A wide range of OAR is included in this study, to be able to document doses to organs that are further away from the target volume, and also to quantify low doses to organs.
1 secondary outcome
Normal tissue complication probability (NTCP) for a fixed tumor dose
Time frame: 3 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 22 Jan 2016.
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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.
Danielle Eekers, Dr. principal investigator
Maastro Clinic, Dr Tanslaan 12, Maastricht, The Netherlands
Philippe lambin, prof, Dr study director
Maastro Clinic, Dr Tanslaan 12, Maastricht, 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 Carcinoma, Squamous Cell of Head and Neck, run by Maastricht Radiation Oncology at 1 site in Netherlands.
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 8 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: finished, as of the sponsor's last update on 22 Jan 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 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?
Radiation exposure for organs at risk in H&N cancer patients (time frame: 7 weeks). 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 22 Jan 2016.