A chemotherapy response adapted management of an intense standard of care treatment regimen of classical Hodgkin Lymphoma in children, where the radiation therapy can be omitted based on the risk assessed through Positron Emission and Computerized Tomography imaging technique

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: Intervention1: RCT Arm: Arm‐A: For patients enrolled on the study, the decision on radiotherapy to baseline bulky sites will be based on response in PET‐CT scan. In arm A, there will be no administration of radiotherapy. Control Intervention1: RCT ARM: Arm‐B: In arm B, radiotherapy to a dose of 19.8Gy will be administered to the bulky site. CONDITION: Health Condition 1: C819‐ Hodgkin lymphoma, unspecified Health Condition 2: C813‐ Lymphocyte depleted Hodgkin lymphoma Health Condition 3: C814‐ Lymphocyte‐rich Hodgkin lymphoma Health Condition 4: C812‐ Mixed cellularity Hodgkin lymphoma Health Condition 5: C811‐ Nodular sclerosis Hodgkin lymphoma Health Condition 6: C817‐ Other Hodgkin lymphoma PRIMARY OUTCOME: The primary endpoint is Event free survival, which is calculated from the date of randomization to relapse, progression, death and occurrence of second malignant neoplasm or last follow up in the RCT arm. In the descriptive arm, Event free survival will be calculated from the date of start of chemotherapy to event or last follow up.Timepoint: Randomization, progression/relapse, secondary malignancy, death, last date of follow‐up to be recorded till 3 years from the day of last randomized patient in RCT arm SECONDARY OUTCOME: The secondary endpoint is Overall survival, which will be calculated from the date of randomization to death due to any cause, or last follow up in the RCT arm. In the descriptive arm, Overall survival will be calculated from the date of start of chemotherapy to death due to any cause or last follow up.Timepoint: Start of Chemotherapy, death, last date of follow‐up to be recorded till 3 years from the day of last randomized patient in RCT arm INCLUSION CRITERIA: 1.Children less than or equal to 18 years of age 2.Newly diagnosed Biopsy proven cHL 3.Adequate response on Early Response Assessment PET‐CT after 2 cycles OEPA in baseline bulky disease (to be eligible for randomization in RCT arm) 4.Written Informed consent approved by local ethics committee from patientâ??s parents or guardian
Epistemonikos ID: 1b6daf6bec7ecad6cccfcc3ea356337f169a0785
First added on: Apr 23, 2024