Clinical trials

ReRad III (DACG 5): Pencil beam proton therapy for recurrences in anal cancer patients previously treated with radiotherapy

This prospective, non-randomized study aims to determine toxicity and efficacy of re-irradiation for patients with recurrences with dose-escalated pencil beam proton therapy.

National investigator: Camilla Kronborg
DCPT investigator: Camilla Kronborg

• Read more about the protocol at clinicaltrials.gov
• More information about the protocol (in Danish) at the Danish Comprehensive Cancer Center/Danish Cancer Society database 

DNOG2: Cognitive Function After Radiation Therapy for Primary Brain Tumours

The study is a prospective nationwide study including approximately 300 brain tumour patients from the Danish Centre for Particle Therapy and the four Neuro Oncology centres in Denmark.

National investigator: Lene Haldbo-Classen
DCPT investigator: Morten Høyer

• Read more about the protocol at clinicaltrials.gov 
• More information about the protocol (in Danish) at the Danish Comprehensive Cancer Center/Danish Cancer Society database 

Glioblastom Dose Escalated dose Proton therapy within the multimodality treatment of Glioblastoma patients. A phase 1 proton dose finding trial

The aim of this trial is to identify the maximum tolerated PT dose in GBM patients treated with multimodality treatment, according to treatment volume.

National investigator: Anouk K. Trip
DCPT investigator: Anouk K. Trip

Read more about the protocol at clinicaltrials.gov

The DBCG Proton Trial (Skagen 2)

Adjuvant breast proton radiation therapy for early breast cancer patients: The Skagen Trial 2, a clinically controlled randomised phase III trial

This trial tests standard photon radiotherapy versus experimental proton radiotherapy for selected early breast cancer patients. The primary endpoint is 10 year risk of heart disease.

National investigator: Birgitte Vrou Offersen
DCPT investigator: Birgitte Vrou Offersen

• Read more about the protocol at clinicaltrials.gov 
• More information about the protocol (in Danish) at the Danish Comprehensive Cancer Center/Danish Cancer Society database 

PROTECT: PROton versus photon Therapy for Esophageal Cancer -  a Trimodality stretegy

A multicenter international randomized phase III study of neoadjuvant proton versus photon chemoradiotherapy in locally advanced esophageal cancer. The study hypothesis is that radiation dose reductions to critical OARs in the thorax, such as heart and particularly the lungs, using trimodality nCPT compared to nCXT, will result in lower rates of treatment related complications.

National investigator: Marianne Norsmark 

DCPT investigator: Hanna Mortensen

• Read more about the protocol at clinicaltrials.gov
• More information about the protocol (in Danish) at the Danish Comprehensive Cancer Center/Danish Cancer Society database

DAHANCA35: A national randomised trial of proton versus photon radiotherapy for the treatment of head-neck cancer

This study evaluates the anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia.

National investigator: Jeppe Friborg
DCPT investigator: Kenneth Jensen

• Read more about the protocol at clinicaltrials.gov 
• More information about the protocol (in Danish) at the Danish Comprehensive Cancer Center/Danish Cancer Society database 

DAHANCA37: Re-irradiation with Proton Radiotherapy 

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.

National investigator: Kenneth Jensen
DCPT investigator: Kenneth Jensen

• Read more about the protocol at clinicaltrials.gov 
• More information about the protocol (in Danish) at the Danish Comprehensive Cancer Center/Danish Cancer Society database 

DAHANCA30: A Randomised Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC

In DAHANCA30, expected hypoxia profile guided non-responders are randomized to +/- nimorazole during radiotherapy. This in order to verify clinical use of the gene profile in selecting the relevant patients for hypoxic modification of radiotherapy with nimorazole.

National investigator: Jens Overgaard/Kasper Toustrup
DCPT investigator: Kenneth Jensen

• Read more about the protocol at clinicaltrials.gov
• More information about the protocol (in Danish) at the Danish Comprehensive Cancer Center/Danish Cancer Society database 

CSI ProLong: Phase II Study of Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis

Patients with leptomeningeal metastasis from both solid and hematological cancers will be offered proton radiotherapy with 30 Gy in 10 fractions to the entire craniospinal axis. Patients will be referred from Danish departments of radiotherapy and followed, at their referring centre with registration of side effects, neurology and MRI scans every 3 months until 1 year.

National/DCPT investigator: Kenneth Jensen

• Read more about the trial at clinicaltrials.gov
• More information about the protocol (in Danish) at the Danish Comprehensive Cancer Center/Danish Cancer Society Database

HCC Proton: A national phase II study of proton therapy in hepatocellular carcinoma

The aim is to offer a safe and efficient radiation treatment to fragile patients with reduced dose to the normal liver compared to conventional photon-based radiotherapy.

National investigator: Britta Weber, Hanna Mortensen

DCPT investigator: Britta Weber, Hanna Mortensen

• Read more about the protocol at clinicaltrials.gov

More information about the protocol (in Danish) at the Danish Comprehensive Cancer Center/Danish Cancer Society database

HERAN2: Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC

Aim: To test if proton therapy can improve survival compared to photon therapy in patients with locally advanced NSCLC who are not candidates for standard definitive chemo-radiotherapy.

National investigator: Tine Schytte

DCPT investigator: Ditte S. Møller, Hanna Rahbek Mortensen

• Read more about the protocol at clinicaltrials.gov

Medulloblastoma

HR-MB. SIOP High-Risk Medulloblastoma: An international prospective trial on high-risk Medulloblastoma in patients older than 3 years

An international study comparing a number of treatment options for patients older than three years with medulloblastoma and clinical or biological features that make these patients more difficult to treat (high-risk disease).

• Read more about the protocol 

Ependymoma

SIOP EP II: An international clinical program for the diagnosis and treatment of children, adolescents and young adults with ependymoma

The overall aim of this project is to improve the outcome of patients diagnosed with ependymoma by improving and harmonising the staging and the standard of care of this patient population and to improve the investigators understanding of the underlying biology thereby informing future treatment. The programme will evaluate new strategies for diagnosis (centralized reviews of pathology and imaging) and new therapeutic strategies in order to develop treatment recommendations.

National investigator: Ines Kristensen
DCPT investigator:  Yasmin Lassen

• Read more about the protocol at clinicaltrials.gov

Wilms tumor

• UMBRELLA (UMBRELLA PROTOCOL SIOP-RTSG 2016): Integrated research and guidelines for standardized diagnostics and therapy

Rhabdomyosarcoma (RMS)

FaR-RMS. An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma 

The trial is trying to answer a number of questions about the treatment of RMS. These include looking at:

• new combinations of chemotherapy as initial treatment (induction)
• the timing, dose and extent of radiotherapy
• chemotherapy to keep the cancer under control after initial chemotherapy.

The main aims of the trial are to improve treatment outcomes and quality of life.

National investigator: Lisa Hjalgrim
DCPT investigator: Akmal Safwat

• Read more about the protocol
  

Neuroblastoma HR-NLB 

Randomized, international and multicentric phase 3 study that

evaluates and compares 2 treatment strategies in 3 therapeutic

phases (induction, high-dose chemotherapy and radiotherapy) for

patients with high-risk neuroblastoma.

R-I:

Comparison of the EFS rate of 2 induction regimens, GPOH and

RAPID COJEC, in patients with high-risk neuroblastoma.

R-HDC:

Comparison of the EFS rate of single HDC with busulphan and

melphalan (Bu-Mel) versus tandem HDC with Thiotepa followed by

Bu-Mel in patients with high-risk neuroblastoma.

R-RTx:

Comparison of the EFS rate of 21.6 Gy radiotherapy to the preoperative tumor bed versus 21.6 Gy radiotherapy and a sequential

boost up to 36 Gy to the residual tumor in patients with macroscopic

residual disease after HDC and surgery.

National investigator: Jesper Sune Brok

DCPT investigator: Britta Weber

• Read more about the protocol at clnicaltrials.gov

Atypical teratoid/rhabdoid tumours: AT-RT-01
Prospective, open label, multicentre, international umbrella trial including a randomized phase III study evaluating the non-inferiority of 3 courses of high-dose chemotherapy compared to focal radiotherapy plus standard chemotherapy as a consolidation measure following conventional chemotherapy in children with ATRT ranging from 12 – 35 months at the time of consolidation (RT vs. HDCT).

National investigator: Karsten Nysom

DCPT investigator: Yasmin Lassen

All paediatric cancers

HARMONIC: Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs

The goal of the HARMONIC-RT study is to evaluate late health and social outcomes of modern external beam radiotherapy techniques in paediatric patients, based on the setting-up of a European, long-term registry complemented by a biobank.

National investigator: Yasmin Lassen
DCPT investigator: Yasmin Lassen

• Read more about the protocol at clinicaltrials.gov
• https://www.nationaltforsoegsoverblik.dk/trial

PRO-PROTON 1: Lymph node radiation therapy with integrated boost to prostate for high-risk prostate cancer

A randomized phase 3 trial comparing photons vs. protons

National investigator: Lise Bentzen

DCPT investigator: Stine Elleberg Petersen, Ludvig Muren

• Read more about the protocol at clinicaltrials.gov

ReRad II: Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy

A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer.

National investigator: Camilla Kronborg
DCPT investigator: Camilla Kronborg

• Read more about the protocol at clinicaltrials.gov

• Sinonasal cancer: PROTIS
• Lymphoma: PROMLY
• Ewing sarcoma: INTER-EWING-1
• Thoracic reirradiation: CURE Lung