Ignite Creation Date:
2024-05-06 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05284396
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-03-17
First Post:
2022-03-09
Brief Title:
Involved Nodal Irradiation vs Involved Field Irradiation After Cth in Ttt of Early Stages HDs
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Involved Nodal Irradiation vs Involved Field Irradiation After Cth in Ttt of Early Stages HDs
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
determine progression-free survival and late toxisty
Detailed Description:
Hodgkin lymphoma HL is one of the most frequent lymphomas in the Western world with an annual incidence of about 3 cases per 100000 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 8260 of 80500 the remainder being Non-Hodgkin lymphoma Of 21210 estimated deaths yearly due to lymphoma about 1070 or 5 are from Hodgkin lymphoma It accounts for about 05 of newly diagnosed cases of cancer in the United States and about 02 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 cells3
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 lymphoma4
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 Hodgkins 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-PETCT 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 tissues6
The advent of combined modality treatment had previously led to a Shift in practice from extended field radiotherapy techniques to involved Field radiotherapy IFRT7-8
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 areas9-11
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 lymphoma4
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 Hodgkins 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-PETCT 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 tissues6
The advent of combined modality treatment had previously led to a Shift in practice from extended field radiotherapy techniques to involved Field radiotherapy IFRT7-8
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 areas9-11
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None