NCT05284396

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

2.4 years

First QC Date

March 9, 2022

Last Update Submit

March 9, 2022

Conditions

Outcome Measures

Primary Outcomes (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

    baseline

Interventions

IFRT vs NFRTRADIATION

involved field irradiation versus nodal field irradiation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Marwa Esam Eldin

CONTACT

Mostafa Abd Elwanees

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Marwa Esam Eldin

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 17, 2022

Study Start

May 1, 2022

Primary Completion

October 1, 2024

Study Completion

October 1, 2025

Last Updated

March 17, 2022

Record last verified: 2022-03