Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2025-12-24 @ 7:54 PM
NCT ID:
NCT06883604
Eligibility Criteria:
Inclusion 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 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06883604
Study Brief:
Protocol Section:
NCT06883604