Hodgkin LymphomaPRO-HodgkinNCT06883604
Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
A study testing Proton therapy. in people with Hodgkin Lymphoma, run by Uppsala University Hospital at 6 sites in Sweden.
Trial summary
Hodgkin Lymphoma patients with limited stage are commonly cured with limited chemotherapy followed by radiotherapy. Studies have shown a risk of late toxicity from the radiotherapy, such as second cancer, heart failure and lung toxicity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Proton therapy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 6 sitesSweden
- Study dates
- 1 Sep 2019to Jun 2041
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Histological diagnosis of classic Hodgkin Lymphoma.
- Ann Arbour stage 1A, 1B or 2A.
- Both patients with and without risk factors, i.e. bulky disease, erythrocyte sedimentation rate (ESR)>50, more than two involved sites.
- Supra diaphragmal disease.
- Age 18-60 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
Show all 12Show fewer
- Initial staging positron emission tomography/computed tomography (PET/CT).
- Induction chemotherapy including 2 cycles of ABVD for patients without risk factors and 4 cycles of ABVD for patients with risk factors.
- For patients with risk factors a CT after 2 ABVD confirming complete remission (CR) or partial remission (PR). For patients without risk factors clinical response is sufficient at inclusion, but a CT scan is recommended before start of radiotherapy.
- Radiotherapy (RT) start not later than 6 weeks after end of chemotherapy.
- Written informed consent obtained prior to any study specific procedures.
- Women of reproductive age must agree to use contraceptives during the study treatment period.
Who cannot join
- Pregnancy.
- Serious concomitant systemic disorder endangering treatment delivery.
- More than 5mm tumour motion on 4 dimensional computed tomography (4DCT) unless deep inspiration breath hold (DIBH) is used. Not applicable if target is located outside mediastinum or photon treatment is planned.
- Clinical or radiographic stable disease (SD)/ progressive disease (PD) during induction chemotherapy.
- Not able to comply with treatment and study procedures.
- No additional active malignancy except indolent lymphoma in the bone marrow, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Sweden6 sites, 6 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, S-41345
Christina Goldkuhl, MD
- Recruiting
Skane University Hospital
Lund, S-22242
Johan Linderoth, MD, Phd
- Recruiting
Orebro University Hospital
Örebro, S-70185
Jenny Kahlmeter Brandell
- Recruiting
Karolinska University Hospital
Solna, S-17176
Marzia Palma, MD, PhD
Lotta Hansson
- Recruiting
Umea University Hospital
Umeå, S-90737
Ann-Sofie Johansson, MD, PhD
- Recruiting
Uppsala University Hospital
Uppsala, S-75185
Daniel Molin, MD, PhD
About this study
Official title: Clinical Investigation of PBS Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
Hodgkin Lymphoma patients with limited stage are commonly cured with limited chemotherapy followed by radiotherapy. Studies have shown a risk of late toxicity from the radiotherapy, such as second cancer, heart failure and lung toxicity. With proton therapy the dose to normal tissue can be minimised without compromising the dose to the tumor. The aim of our study is to investigate whether proton therapy can be delivered in a safe way to Hodgkin Lymphoma patients with less late side effects than conventional radiotherapy, while retaining the high cure rate.
This is a multicentre phase II study of PBS proton beam therapy in patients ≤60 years, with early stage Hodgkin Lymphoma treated with induction chemotherapy. The study is performed in a non-inferiority setting comparing with a historical population-based consecutive Swedish material. The control group was treated according to the same principles, except that the radiotherapy was delivered with photons.
- Conditions
- Hodgkin Lymphoma
- Being tested
- Proton therapy.
- Keywords
- Proton therapy
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton therapy.Radiation
Pencil beam scanning proton therapy to a dose of 20 or 29.75 Gy (RBE) after standard chemotherapy (2-4 ABVD).
| Study group | Role | What they receive |
|---|---|---|
| Proton therapy | Experimental | Stage 1-2A Hodgkin Lymphoma. Receives: Radiation: Proton therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Time from study entry until disease progression or death from any cause.
Measured: Outcome will be measured after 1, 3, 5 and 16 years.
Secondary outcomes (8)
Overall survival (OS)
Time from diagnostic biopsy until death from any cause.
Measured: Outcome will be measured after 1, 3, 5 and 16 years.
Time to progression (TTP)
Time from diagnostic biopsy until objective tumor progression, not includingdeath.
Measured: Outcome will be measured after 1, 3, 5 and 16 years.
Absorbed dose to organs at risk.
Will be collected from Dose Volume Histograms.
Measured: Outcome will be measured at baseline.
Patterns of failure.
Are failures located within or outside of the radiation field?
Measured: Outcome will be measured after 1, 3, 5 and 16 years.
Acute adverse events.
The incidence of acute toxicities during treatment will be summarized by severity (based on CTCAE grades), type and relation to the study therapy. Acute adverse events are defined as occurring during or within 3 months after radiotherapy.
Measured: Outcome will be measured within 3 months.
Long-term adverse events.
This study specifically includes longitudinal follow-up to assess the incidence of secondary malignant neoplasms, heart- and lung toxicity measured up to 16 years following radiotherapy. Late adverse events are defined as occurring 3 months or later.
Measured: Outcome will be measured after 1, 3, 5 and 16 years.
Quality of life.
EORTC quality of life questionnaire (QLQ)-C30.
Measured: Outcome will be measured after 1, 3, 5 and 16 years.
Quality of life.
EORTC quality of life questionnaire (QLQ)-Hodgkin lymphoma (HL)27.
Measured: Outcome will be measured after 1, 3, 5 and 16 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Sep 2019
- Primary completionJun 2025 (estimated)
- Study completionJun 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hodgkin LymphomaStudies 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
- Model description
- Proton therapy, non-inferiority compared to historical cohort.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, University Hospital, Umeå, Region Örebro County, Karolinska University Hospital, Skane University Hospital, University Hospital, Linkoeping, Skandion Clinic, Swedish Cancer Society
- Responsible party
- Principal investigator, Daniel Molin, Uppsala University Hospital
- Investigators
- Daniel Molin, MD, PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883604
- Sponsor's protocol ID
- 2019-00010
- Other IDs
- 2019
- Acronym
- PRO-Hodgkin
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Specht L, Yahalom J, Illidge T, Berthelsen AK, Constine LS, Eich HT, Girinsky T, Hoppe RT, Mauch P, Mikhaeel NG, Ng A; ILROG. Modern radiation therapy for Hodgkin lymphoma: field and dose guidelines from the international lymphoma radiation oncology group (ILROG). Int J Radiat Oncol Biol Phys. 2014 Jul 15;89(4):854-62. doi: 10.1016/j.ijrobp.2013.05.005. Epub 2013 Jun 18.
PubMed 23790512Maraldo MV, Dabaja BS, Filippi AR, Illidge T, Tsang R, Ricardi U, Petersen PM, Schut DA, Garcia J, Headley J, Parent A, Guibord B, Ragona R, Specht L. Radiation therapy planning for early-stage Hodgkin lymphoma: experience of the International Lymphoma Radiation Oncology Group. Int J Radiat Oncol Biol Phys. 2015 May 1;92(1):144-52. doi: 10.1016/j.ijrobp.2014.12.009. Epub 2015 Feb 7.
PubMed 25670544Aznar MC, Maraldo MV, Schut DA, Lundemann M, Brodin NP, Vogelius IR, Berthelsen AK, Specht L, Petersen PM. Minimizing late effects for patients with mediastinal Hodgkin lymphoma: deep inspiration breath-hold, IMRT, or both? Int J Radiat Oncol Biol Phys. 2015 May 1;92(1):169-74. doi: 10.1016/j.ijrobp.2015.01.013. Epub 2015 Mar 5.
PubMed 25754634Petersen PM, Aznar MC, Berthelsen AK, Loft A, Schut DA, Maraldo M, Josipovic M, Klausen TL, Andersen FL, Specht L. Prospective phase II trial of image-guided radiotherapy in Hodgkin lymphoma: benefit of deep inspiration breath-hold. Acta Oncol. 2015 Jan;54(1):60-6. doi: 10.3109/0284186X.2014.932435. Epub 2014 Jul 15.
PubMed 25025999Hoppe BS, Flampouri S, Su Z, Morris CG, Latif N, Dang NH, Lynch J, Li Z, Mendenhall NP. Consolidative involved-node proton therapy for Stage IA-IIIB mediastinal Hodgkin lymphoma: preliminary dosimetric outcomes from a Phase II study. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):260-7. doi: 10.1016/j.ijrobp.2011.06.1959. Epub 2011 Oct 17.
PubMed 22014950Hoppe BS, Flampouri S, Su Z, Latif N, Dang NH, Lynch J, Joyce M, Sandler E, Li Z, Mendenhall NP. Effective dose reduction to cardiac structures using protons compared with 3DCRT and IMRT in mediastinal Hodgkin lymphoma. Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):449-55. doi: 10.1016/j.ijrobp.2011.12.034. Epub 2012 Mar 2.
PubMed 22386373Hoppe BS, Flampouri S, Zaiden R, Slayton W, Sandler E, Ozdemir S, Dang NH, Lynch JW, Li Z, Morris CG, Mendenhall NP. Involved-node proton therapy in combined modality therapy for Hodgkin lymphoma: results of a phase 2 study. Int J Radiat Oncol Biol Phys. 2014 Aug 1;89(5):1053-1059. doi: 10.1016/j.ijrobp.2014.04.029. Epub 2014 Jun 10.
PubMed 24928256Hoppe BS, Hill-Kayser CE, Tseng YD, Flampouri S, Elmongy HM, Cahlon O, Mendenhall NP, Maity A, McGee LA, Plastaras JP. Consolidative proton therapy after chemotherapy for patients with Hodgkin lymphoma. Ann Oncol. 2017 Sep 1;28(9):2179-2184. doi: 10.1093/annonc/mdx287.
PubMed 28911093Chang JY, Li H, Zhu XR, Liao Z, Zhao L, Liu A, Li Y, Sahoo N, Poenisch F, Gomez DR, Wu R, Gillin M, Zhang X. Clinical implementation of intensity modulated proton therapy for thoracic malignancies. Int J Radiat Oncol Biol Phys. 2014 Nov 15;90(4):809-18. doi: 10.1016/j.ijrobp.2014.07.045. Epub 2014 Sep 24.
PubMed 25260491Zeng C, Plastaras JP, Tochner ZA, White BM, Hill-Kayser CE, Hahn SM, Both S. Proton pencil beam scanning for mediastinal lymphoma: the impact of interplay between target motion and beam scanning. Phys Med Biol. 2015 Apr 7;60(7):3013-29. doi: 10.1088/0031-9155/60/7/3013. Epub 2015 Mar 19.
PubMed 25789418Zeng C, Plastaras JP, James P, Tochner ZA, Hill-Kayser CE, Hahn SM, Both S. Proton pencil beam scanning for mediastinal lymphoma: treatment planning and robustness assessment. Acta Oncol. 2016 Sep-Oct;55(9-10):1132-1138. doi: 10.1080/0284186X.2016.1191665. Epub 2016 Jun 22.
PubMed 27332881
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of PBS Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
- ClinicalTrials.gov ID
- NCT06883604
- Acronym / sponsor ID
- PRO-Hodgkin / 2019-00010
- Conditions
- Hodgkin Lymphoma
- Keywords
- Proton therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, University Hospital, Umeå, Region Örebro County, Karolinska University Hospital, Skane University Hospital, University Hospital, Linkoeping, Skandion Clinic, Swedish Cancer Society
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2041 (estimated)
- First posted
- 19 Mar 2025 (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.
Hodgkin Lymphoma patients with limited stage are commonly cured with limited chemotherapy followed by radiotherapy. Studies have shown a risk of late toxicity from the radiotherapy, such as second cancer, heart failure and lung toxicity. With proton therapy the dose to normal tissue can be minimised without compromising the dose to the tumor. The aim of our study is to investigate whether proton therapy can be delivered in a safe way to Hodgkin Lymphoma patients with less late side effects than conventional radiotherapy, while retaining the high cure rate.
This is a multicentre phase II study of PBS proton beam therapy in patients ≤60 years, with early stage Hodgkin Lymphoma treated with induction chemotherapy. The study is performed in a non-inferiority setting comparing with a historical population-based consecutive Swedish material. The control group was treated according to the same principles, except that the radiotherapy was delivered with photons.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proton therapy, non-inferiority compared to historical cohort.
| Arm | Type | Receives |
|---|---|---|
| Proton therapy | Experimental | Radiation: Proton therapy.Stage 1-2A Hodgkin Lymphoma. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Histological diagnosis of classic Hodgkin Lymphoma.
- Ann Arbour stage 1A, 1B or 2A.
- Both patients with and without risk factors, i.e. bulky disease, erythrocyte sedimentation rate (ESR)>50, more than two involved sites.
- Supra diaphragmal disease.
- Age 18-60 years.
Key exclusion criteria (6 listed)
- Pregnancy.
- Serious concomitant systemic disorder endangering treatment delivery.
- More than 5mm tumour motion on 4 dimensional computed tomography (4DCT) unless deep inspiration breath hold (DIBH) is used. Not applicable if target is located outside mediastinum or photon treatment is planned.
- Clinical or radiographic stable disease (SD)/ progressive disease (PD) during induction chemotherapy.
- Not able to comply with treatment and study procedures.
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 |
|---|---|---|
| Proton therapy.Pencil beam scanning proton therapy to a dose of 20 or 29.75 Gy (RBE) after standard chemotherapy (2-4 ABVD). | Radiation | Proton therapy |
Primary outcome
Progression free survival (PFS)
Time frame: Outcome will be measured after 1, 3, 5 and 16 years.
Time from study entry until disease progression or death from any cause.
8 secondary outcomes
Overall survival (OS)
Time frame: Outcome will be measured after 1, 3, 5 and 16 years.
Time to progression (TTP)
Time frame: Outcome will be measured after 1, 3, 5 and 16 years.
Absorbed dose to organs at risk.
Time frame: Outcome will be measured at baseline.
Patterns of failure.
Time frame: Outcome will be measured after 1, 3, 5 and 16 years.
Acute adverse events.
Time frame: Outcome will be measured within 3 months.
Long-term adverse events.
Time frame: Outcome will be measured after 1, 3, 5 and 16 years.
Quality of life.
Time frame: Outcome will be measured after 1, 3, 5 and 16 years.
Quality of life.
Time frame: Outcome will be measured after 1, 3, 5 and 16 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Background: PubMed 23790512Specht L, Yahalom J, Illidge T, Berthelsen AK, Constine LS, Eich HT, Girinsky T, Hoppe RT, Mauch P, Mikhaeel NG, Ng A; ILROG. Modern radiation therapy for Hodgkin lymphoma: field and dose guidelines from the international lymphoma radiation oncology group (ILROG). Int J Radiat Oncol Biol Phys. 2014 Jul 15;89(4):854-62. doi: 10.1016/j.ijrobp.2013.05.005. Epub 2013 Jun 18.
- Background: PubMed 25670544Maraldo MV, Dabaja BS, Filippi AR, Illidge T, Tsang R, Ricardi U, Petersen PM, Schut DA, Garcia J, Headley J, Parent A, Guibord B, Ragona R, Specht L. Radiation therapy planning for early-stage Hodgkin lymphoma: experience of the International Lymphoma Radiation Oncology Group. Int J Radiat Oncol Biol Phys. 2015 May 1;92(1):144-52. doi: 10.1016/j.ijrobp.2014.12.009. Epub 2015 Feb 7.
- Background: PubMed 25754634Aznar MC, Maraldo MV, Schut DA, Lundemann M, Brodin NP, Vogelius IR, Berthelsen AK, Specht L, Petersen PM. Minimizing late effects for patients with mediastinal Hodgkin lymphoma: deep inspiration breath-hold, IMRT, or both? Int J Radiat Oncol Biol Phys. 2015 May 1;92(1):169-74. doi: 10.1016/j.ijrobp.2015.01.013. Epub 2015 Mar 5.
- Background: PubMed 25025999Petersen PM, Aznar MC, Berthelsen AK, Loft A, Schut DA, Maraldo M, Josipovic M, Klausen TL, Andersen FL, Specht L. Prospective phase II trial of image-guided radiotherapy in Hodgkin lymphoma: benefit of deep inspiration breath-hold. Acta Oncol. 2015 Jan;54(1):60-6. doi: 10.3109/0284186X.2014.932435. Epub 2014 Jul 15.
- Background: PubMed 22014950Hoppe BS, Flampouri S, Su Z, Morris CG, Latif N, Dang NH, Lynch J, Li Z, Mendenhall NP. Consolidative involved-node proton therapy for Stage IA-IIIB mediastinal Hodgkin lymphoma: preliminary dosimetric outcomes from a Phase II study. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):260-7. doi: 10.1016/j.ijrobp.2011.06.1959. Epub 2011 Oct 17.
- Background: PubMed 22386373Hoppe BS, Flampouri S, Su Z, Latif N, Dang NH, Lynch J, Joyce M, Sandler E, Li Z, Mendenhall NP. Effective dose reduction to cardiac structures using protons compared with 3DCRT and IMRT in mediastinal Hodgkin lymphoma. Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):449-55. doi: 10.1016/j.ijrobp.2011.12.034. Epub 2012 Mar 2.
- Background: PubMed 24928256Hoppe BS, Flampouri S, Zaiden R, Slayton W, Sandler E, Ozdemir S, Dang NH, Lynch JW, Li Z, Morris CG, Mendenhall NP. Involved-node proton therapy in combined modality therapy for Hodgkin lymphoma: results of a phase 2 study. Int J Radiat Oncol Biol Phys. 2014 Aug 1;89(5):1053-1059. doi: 10.1016/j.ijrobp.2014.04.029. Epub 2014 Jun 10.
- Background: PubMed 28911093Hoppe BS, Hill-Kayser CE, Tseng YD, Flampouri S, Elmongy HM, Cahlon O, Mendenhall NP, Maity A, McGee LA, Plastaras JP. Consolidative proton therapy after chemotherapy for patients with Hodgkin lymphoma. Ann Oncol. 2017 Sep 1;28(9):2179-2184. doi: 10.1093/annonc/mdx287.
- Background: PubMed 25260491Chang JY, Li H, Zhu XR, Liao Z, Zhao L, Liu A, Li Y, Sahoo N, Poenisch F, Gomez DR, Wu R, Gillin M, Zhang X. Clinical implementation of intensity modulated proton therapy for thoracic malignancies. Int J Radiat Oncol Biol Phys. 2014 Nov 15;90(4):809-18. doi: 10.1016/j.ijrobp.2014.07.045. Epub 2014 Sep 24.
- Background: PubMed 25789418Zeng C, Plastaras JP, Tochner ZA, White BM, Hill-Kayser CE, Hahn SM, Both S. Proton pencil beam scanning for mediastinal lymphoma: the impact of interplay between target motion and beam scanning. Phys Med Biol. 2015 Apr 7;60(7):3013-29. doi: 10.1088/0031-9155/60/7/3013. Epub 2015 Mar 19.
- Background: PubMed 27332881Zeng C, Plastaras JP, James P, Tochner ZA, Hill-Kayser CE, Hahn SM, Both S. Proton pencil beam scanning for mediastinal lymphoma: treatment planning and robustness assessment. Acta Oncol. 2016 Sep-Oct;55(9-10):1132-1138. doi: 10.1080/0284186X.2016.1191665. Epub 2016 Jun 22.
- 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.
Daniel Molin, MD, PhD principal investigator
Uppsala University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton therapy. in people with Hodgkin Lymphoma, run by Uppsala University Hospital at 6 sites in Sweden.
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 12 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Molin, MD, PhD (+46186110000, daniel.molin@igp.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Outcome will be measured after 1, 3, 5 and 16 years.). 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 NCT06883604, which also lists 11 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 19 Mar 2025.