AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

Marwa Esam Eldin contact

01061544691

marwa.me49@gmail.com

Mostafa Abd Elwanees contact

012211333032

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)

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.

  1. 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.

  1. First posted17 Mar 2022
  2. Study start1 May 2022 (estimated)
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion1 Oct 2025 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in