Head and Neck NeoplasmsNCT03981068
DAHANCA 37. Re-irradiation With Proton Radiotherapy
A study testing Re-irradiation in people with Head and Neck Neoplasms, run by Danish Head and Neck Cancer Group at 1 site in Denmark.
Trial summary
Summary Design Phase II observational Treatment 60 Gy/50 fx / 10W-1 at 1.2 Gy/fx o i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively Proton radiotherapy Concomitant cisplatin for eligible patients* Nimorazole recommended for SCC* *The concurrent medical treatment (weekly cisplatin and nimorazole)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Re-irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2019to 30 Aug 2025
- Phase
- Interventional
- 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
Who may be able to join
- Histological verified loco-regional recurrence or new primary
- Available dose plan from primary radiotherapy course
- Comparative dose plan with advantages for proton radiotherapy e.g. integral dose
- Dmax dose (0.03 cm3) on the cumulated photon dose plan≥90 Gy
- Complete Response (CR)* after initial therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose.
- Inoperable or salvage surgery with R1/R2 resection, extranodal extension (ENE) or extensive soft tissue infiltration
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- Absence of distant metastasis at both
- clinical examination AND
- PET-CT or CT of thorax and upper abdomen
- Life expectancy due to age and co-morbidity of >=1 year. The general condition must be sufficient to tolerate persistent significant side effects, e.g. tube or cannulae
- PS<=2 (WHO See appendix)
Who cannot join
- Radical surgery (R0) and absence of adverse prognostic pathological features
- Lymphoma or malignant melanoma
- Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
- As of 2019, patients with tracheal cannulas are excluded due to dose uncertainties. This may change if a technical solution becomes available.
Trial locations and contacts
1 site in 1 country.
Jesper Eriksen, Professor contact
Denmark1 site, 1 recruiting
- Recruiting
Danish Center for Particle Therapy
Aarhus, 8200
Kenneth Jensen, Ph.D., 78450000 ext. 45, kennjens@rm.dk
Dorte Winther, Nurse, 78450000, dorte.skriver.winther@auh.rm.dk
About this study
Official title: DAHANCA 37 A Phase II Study of Intensity Modulated Proton Therapy (IMPT) for Re-irradiation With Curative Intent for Recurrent or New Primary Head and Neck Cancer
Summary Design Phase II observational
Treatment
- 60 Gy/50 fx / 10W-1 at 1.2 Gy/fx
- i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively
- Proton radiotherapy
- Concomitant cisplatin for eligible patients*
- Nimorazole recommended for SCC* *The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment.
Endpoints
- Primary:
- Any new late toxicity grade >=3 according to CTC AE 5.0
- Secondary
- Side effects according to DAHANCA scoring system
- Quality of life and PROM according to EORTC C30 and HN43
- Loco-regional control (LRC)
- Overall survival (OS)
Read the detailed description
Summary Design Phase II observational Inclusion criteria
- Histological verified loco-regional recurrence or new primary
- Available dose plan from primary radiotherapy course
- Comparative dose plan with advantages for proton radiotherapy e.g. integral dose
- Dmax dose (0.03 cm3) on the cumulated photon dose plan≥90 Gy
- Complete Response (CR)* after initial therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose.
- Inoperable or salvage surgery with R1/R2 resection, extranodal extension (ENE) or extensive soft tissue infiltration
- Absence of distant metastasis at both
- clinical examination AND
- PET-CT or CT of thorax and upper abdomen
- Life expectancy due to age and co-morbidity of >=1 year. The general condition must be sufficient to tolerate persistent significant side effects, e.g. tube or cannulae
- PS<=2 (WHO See appendix)
- The patients should be able to read Danish in order to participate with quality of life questionnaires, but can participate in the rest of the protocol without being fluent in Danish, if capable of reading the patient information.
- Complete Response is defined as the situation when a trained clinician, ideally at a multidisciplinary team conference, defines the patient as in complete remission, based on clinical examination and available imaging. This status can of course later be considered wrong as new information becomes available (sub-centimeter nodes grow etc.) Exclusion criteria
- Radical surgery (R0) and absence of adverse prognostic pathological features
- Lymphoma or malignant melanoma
- Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
- As of 2019, patients with tracheal cannulas are excluded due to dose uncertainties. This may change if a technical solution becomes available.
Treatment
- 60 Gy/50 fx / 10W-1 at 1.2 Gy/fx
- i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively
- Proton radiotherapy
- Concomitant cisplatin for eligible patients*
- Nimorazole recommended for SCC* *The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment.
Endpoints
- Primary:
- Any new late toxicity grade >=3 according to CTC AE 5.0
- Secondary
- Side effects according to DAHANCA scoring system
- Quality of life and PROM according to EORTC C30 and HN43
- Loco-regional control (LRC)
- Overall survival (OS)
Derived projects
- Morbidity (NTCP) modeling for cumulative doses
- Metrics for uncertainties regarding cumulative doses
- Conditions
- Head and Neck Neoplasms
- Being tested
- Re-irradiation
- Keywords
- recurrent, reirradiation, second primary
- Medical subject headings
- Head and Neck Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-irradiationRadiation
Also called cisplatin, nimorazole
Cisplatin for all eligible patients, nimorazole for all SCC
| Study group | Role | What they receive |
|---|---|---|
| Re-Irradiation with protons | Experimental | 60 Gy in 50 fraktions, 10 weekly with protons Receives: Radiation: Re-irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any new grade >=3 toxicity
CTC AE 5.0
Measured: 3 years after radiotherapy
Secondary outcomes (4)
Side effects, any grade
According to CTC AE or Dahanca
Measured: 5 years after radiotherapy
Quality of life and PROM
EORTC QLQ HN43 , swallowing scale. Difference (mean) between baseline and 6 months
Measured: 6 months
Loco-regional control (LRC)
Abscence of locoregional failure
Measured: 5 years after radiotherapy -actuarial analysis
Overall survival (OS)
Abscence of death
Measured: Median Survival up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start1 Sep 2019
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Head and Neck Cancer Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Kenneth Jensen, Principal investigator, Danish Centre for Particle Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981068
- Sponsor's protocol ID
- Dahanca 37
- Status last verified
- Sep 2020
- First submitted
- 30 May 2019
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAHANCA 37 A Phase II Study of Intensity Modulated Proton Therapy (IMPT) for Re-irradiation With Curative Intent for Recurrent or New Primary Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03981068
- Acronym / sponsor ID
- Dahanca 37
- Conditions
- Head and Neck Neoplasms
- Keywords
- recurrent, reirradiation, second primary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Danish Head and Neck Cancer GroupResearch network
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 10 Jun 2019 (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.
Summary Design Phase II observational
Treatment
- 60 Gy/50 fx / 10W-1 at 1.2 Gy/fx
- i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively
- Proton radiotherapy
- Concomitant cisplatin for eligible patients*
- Nimorazole recommended for SCC* *The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment.
Endpoints
- Primary:
- Any new late toxicity grade >=3 according to CTC AE 5.0
- Secondary
- Side effects according to DAHANCA scoring system
- Quality of life and PROM according to EORTC C30 and HN43
- Loco-regional control (LRC)
- Overall survival (OS)
Detailed description
Summary Design Phase II observational Inclusion criteria
- Histological verified loco-regional recurrence or new primary
- Available dose plan from primary radiotherapy course
- Comparative dose plan with advantages for proton radiotherapy e.g. integral dose
- Dmax dose (0.03 cm3) on the cumulated photon dose plan≥90 Gy
- Complete Response (CR)* after initial therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose.
- Inoperable or salvage surgery with R1/R2 resection, extranodal extension (ENE) or extensive soft tissue infiltration
- Absence of distant metastasis at both
- clinical examination AND
- PET-CT or CT of thorax and upper abdomen
- Life expectancy due to age and co-morbidity of >=1 year. The general condition must be sufficient to tolerate persistent significant side effects, e.g. tube or cannulae
- PS<=2 (WHO See appendix)
- The patients should be able to read Danish in order to participate with quality of life questionnaires, but can participate in the rest of the protocol without being fluent in Danish, if capable of reading the patient information.
- Complete Response is defined as the situation when a trained clinician, ideally at a multidisciplinary team conference, defines the patient as in complete remission, based on clinical examination and available imaging. This status can of course later be considered wrong as new information becomes available (sub-centimeter nodes grow etc.) Exclusion criteria
- Radical surgery (R0) and absence of adverse prognostic pathological features
- Lymphoma or malignant melanoma
- Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
- As of 2019, patients with tracheal cannulas are excluded due to dose uncertainties. This may change if a technical solution becomes available.
Treatment
- 60 Gy/50 fx / 10W-1 at 1.2 Gy/fx
- i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively
- Proton radiotherapy
- Concomitant cisplatin for eligible patients*
- Nimorazole recommended for SCC* *The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment.
Endpoints
- Primary:
- Any new late toxicity grade >=3 according to CTC AE 5.0
- Secondary
- Side effects according to DAHANCA scoring system
- Quality of life and PROM according to EORTC C30 and HN43
- Loco-regional control (LRC)
- Overall survival (OS)
Derived projects
- Morbidity (NTCP) modeling for cumulative doses
- Metrics for uncertainties regarding cumulative doses
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Re-Irradiation with protons | Experimental | Radiation: Re-irradiation60 Gy in 50 fraktions, 10 weekly with protons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histological verified loco-regional recurrence or new primary
- Available dose plan from primary radiotherapy course
- Comparative dose plan with advantages for proton radiotherapy e.g. integral dose
- Dmax dose (0.03 cm3) on the cumulated photon dose plan≥90 Gy
- Complete Response (CR)* after initial therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose.
Key exclusion criteria (4 listed)
- Radical surgery (R0) and absence of adverse prognostic pathological features
- Lymphoma or malignant melanoma
- Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
- As of 2019, patients with tracheal cannulas are excluded due to dose uncertainties. This may change if a technical solution becomes available.
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 |
|---|---|---|
| Re-irradiationAlso: cisplatin, nimorazoleCisplatin for all eligible patients, nimorazole for all SCC | Radiation | Re-Irradiation with protons |
Primary outcome
Any new grade >=3 toxicity
Time frame: 3 years after radiotherapy
CTC AE 5.0
4 secondary outcomes
Side effects, any grade
Time frame: 5 years after radiotherapy
Quality of life and PROM
Time frame: 6 months
Loco-regional control (LRC)
Time frame: 5 years after radiotherapy -actuarial analysis
Overall survival (OS)
Time frame: Median Survival up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Jesper Eriksen, Professor contact
Kenneth Jensen principal investigator
Danish Centre for Particle Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-irradiation in people with Head and Neck Neoplasms, run by Danish Head and Neck Cancer Group at 1 site in Denmark.
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 11 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Sep 2020. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Jensen, PhD (+45 21284108, kennjens@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any new grade >=3 toxicity (time frame: 3 years after radiotherapy). 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 25 Sep 2020.