Status:
RECRUITING
Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin
Lead Sponsor:
Uppsala University Hospital
Collaborating Sponsors:
Sahlgrenska University Hospital
University Hospital of Umeå
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 can...
Eligibility Criteria
Inclusion
- 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 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2041
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06883604
Start Date
September 1 2019
End Date
June 1 2041
Last Update
March 19 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Sahlgrenska University Hospital
Gothenburg, Sweden, S-41345
2
Skane University Hospital
Lund, Sweden, S-22242
3
Orebro University Hospital
Örebro, Sweden, S-70185
4
Karolinska University Hospital
Solna, Sweden, S-17176