Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05284396 |
| Other study ID # |
radiotherapy in lymphomas |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2022 |
| Est. completion date |
October 1, 2025 |
Study information
| Verified date |
March 2022 |
| Source |
Assiut University |
| Contact |
Marwa Esam Eldin |
| Phone |
01061544691 |
| Email |
marwa.me49[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
determine the early toxicity and loco-regional control comparing outcome of radiothrapy
rither by using INRT or IFRT in treatment of early stage hodgkin lymphoma
determine progression-free survival and late toxisty
Description:
Hodgkin lymphoma (HL) is one of the most frequent lymphomas in the Western world, with an
annual incidence of about 3 cases per 100,000 persons. This lymphoid malignancy involves
peripheral lymph nodes and can also affect organs such as liver, lung, and bone marrow. About
40% of patients suffer from constitutional symptoms ("B-symptoms"). Based on differences in
the histological picture and the phenotype of the tumor cells, HL is subclassified into
nodular sclerosis, mixed cellularity, lymphocyte-rich, lymphocyte-depleted, and nodular
lymphocyte-predominant HL (NLPHL) (1) Hodgkin lymphoma is estimated to account for about 10%
of cases of newly diagnosed lymphoma in the United States (8,260 of 80,500), the remainder
being Non-Hodgkin lymphoma. Of 21,210 estimated deaths yearly due to lymphoma, about 1,070
(or 5%) are from Hodgkin lymphoma. It accounts for about 0.5% of newly diagnosed cases of
cancer in the United States and about 0.2% of all cancer deaths. However lymphoma is the most
common cancer diagnosed in adolescents (aged 15 to 19 years) accounting for 21% of new
diagnoses, almost two-thirds of which is Hodgkin lymphoma (2) In patients with Hodgkin
lymphoma, a definitive diagnosis is critical and requires that the treating physician provide
the pathologist with an adequate pathologic specimen. Fine-needle aspiration or core-needle
biopsy specimens are commonly inadequate because they do not represent the architecture of
the lymph node and therefore preclude an accurate diagnosis. Hodgkin lymphoma has the unique
characteristic of malignant cells constituting only a minority of the intratumoral cell
population, and therefore, a small biopsy specimen may not include sufficient malignant
cells.(3)
To establish a definitive diagnosis, it is necessary to identify Reed-Sternberg cells within
the biopsy specimen. These cells are commonly seen within a rich cellular environment
composed of reactive lymphocytes, eosinophils, and histiocytes. Two distinct disease entities
have been defined in Hodgkin lymphoma, the commonly diagnosed classical Hodgkin lymphoma and
the uncommon nodular lymphocyte-predominant Hodgkin lymphoma.(4)
The past few decades have seen significant progress in the management of pt with HL, it is
curable in at least 80% of patient. Early stage Hodgkin's lymphoma (HL) patients treated with
a combination of chemotherapy and radiotherapy have an excellent clinical outcome, with
overall survival of approximately 90% [5].
With modern techniques, including better CT scan imaging, FDG-PET/CT scans and more accurate
radiation technology ,It is now possible to customize radiotherapy for each patient with
accurate delivery of radiation to the initially involved volume while minimizing the
radiation dose to normal tissues(6).
The advent of combined modality treatment had previously led to a Shift in practice from
extended field radiotherapy techniques to involved Field radiotherapy (IFRT)(7-8).
Some recent studies have shown the safety of further reductions in field sites. With the
concept of involved node radiotherapy (INRT) in order to reduce the risk of
radiotherapy-induced toxicity. INRT is based on treating only initially involved lymph nodes
and excluding adjacent uninvolved nodal areas(9-11)
