BridgeMD
New treatment option for Hodgkin Lymphoma
Official title Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
ClinicalTrials.gov ID: NCT06883604
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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.
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Sweden
- Lund, Sweden
- Örebro, Sweden
- Solna, Sweden
- Umeå, Sweden
- Uppsala, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Sweden; Lund, Sweden; Örebro, Sweden; Solna, Sweden; Umeå, Sweden; Uppsala, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.