Hodgkin LymphomaNCT05284396
Involved Nodal Irradiation vs Involved Field Irradiation After Cth in Ttt of Early Stages HDs
An observational study of Hodgkin Lymphoma, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- IFRT vs NFRT
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: statistical analyses were performed using IBM SPSS Statistics version 20 (SPSS Inc., Chicago, IL, USA). Categorical data were presented as frequencies and percentages, while Chi-square test was used for comparisons between groups. Continuous data were reported as means ±standard deviations and students' T-test was used for comparisons between groups. For comparison between progression free survival ,Kaplan-Mayar survival curve and log-rank test were performed. In all statistical tests p-value <0.05 was considered statistically significant. •Sample size: All pt who met at inclusion criteria at SECI will be included in our study
Who may be able to join
- Histologically proven Hodgkin's Lymphoma, with exclusion of the nodular lymphocyte predominant subtybe
- Clinical stage I or II, only supra-diaphragmatic nodes, both favorable and unfavorable prognostic subsets
- Previously untreated.
- Age: between 18 and 75 years.
- Good general condition(WHO performance status 0-2).
- Free of concurrent disease.
Who cannot join
- Patients with impaired heart, lung, liver, or kidney function.
- Previous malignant diseases or HIV-positive status
- Patient with advanced or infra-diaghragmatic Hodgkin's disease
- Pregnant or lactating women
- Patient with prior irradiation to the neck and thorathic region
Trial locations and contacts
No sites are listed yet.
Mostafa Abd Elwanees contact
About this study
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
Read the 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 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)
- Conditions
- Hodgkin Lymphoma
- Being tested
- IFRT vs NFRT
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFRT vs NFRTRadiation
involved field irradiation versus nodal field irradiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between different irradiation modalities in tretment of early stage hodgkin lymphoma
involved nodal Irradiation versus Involved field Irradiation after Chemotherapy in treatment of Early stage Hodgkin's lymphoma
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Esam Eldin Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284396
- Sponsor's protocol ID
- radiotherapy in lymphomas
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involved Nodal Irradiation vs Involved Field Irradiation After Cth in Ttt of Early Stages HDs
- ClinicalTrials.gov ID
- NCT05284396
- Acronym / sponsor ID
- radiotherapy in lymphomas
- Conditions
- Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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)
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- statistical analyses were performed using IBM SPSS Statistics version 20 (SPSS Inc., Chicago, IL, USA). Categorical data were presented as frequencies and percentages, while Chi-square test was used for comparisons between groups. Continuous data were reported as means ±standard deviations and students' T-test was used for comparisons between groups. For comparison between progression free survival ,Kaplan-Mayar survival curve and log-rank test were performed. In all statistical tests p-value <0.05 was considered statistically significant. •Sample size: All pt who met at inclusion criteria at SECI will be included in our study
Key inclusion criteria (6 listed)
- Histologically proven Hodgkin's Lymphoma, with exclusion of the nodular lymphocyte predominant subtybe
- Clinical stage I or II, only supra-diaphragmatic nodes, both favorable and unfavorable prognostic subsets
- Previously untreated.
- Age: between 18 and 75 years.
- Good general condition(WHO performance status 0-2).
Key exclusion criteria (5 listed)
- Patients with impaired heart, lung, liver, or kidney function.
- Previous malignant diseases or HIV-positive status
- Patient with advanced or infra-diaghragmatic Hodgkin's disease
- Pregnant or lactating women
- Patient with prior irradiation to the neck and thorathic region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IFRT vs NFRTinvolved field irradiation versus nodal field irradiation | Radiation | – |
Primary outcome
Comparison between different irradiation modalities in tretment of early stage hodgkin lymphoma
Time frame: baseline
involved nodal Irradiation versus Involved field Irradiation after Chemotherapy in treatment of Early stage Hodgkin's lymphoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa Abd Elwanees contact
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Lymphoma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Esam Eldin (01061544691, marwa.me49@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between different irradiation modalities in tretment of early stage hodgkin lymphoma (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.