Comparison between radiation to only involved node and involved side of node as well as comparison between when patient will inhale deeply and then hold his /her breath and without imposing any restriction in respiration

Prospective evaluation of involved site versus involved node target volume parameters for deep inspiration breath-hold mediastinal radiation therapy for Hodgkinâ??s lymphoma. - PRIMED - Hodgkin

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/01/011513

Enrollment

Registered

2018-01-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Age equal or greater than 18 years Performance score less than 2 Patients able to tolerate breath-hold of more or equal than 15 seconds as measured by a stopwatch in the clinic

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Previously untreated patients diagnosed with Hodgkinâ??s lymphoma bulky mediastinal involvement where mediastinal RT is expected to be a part of the combined modality treatment 2. Age equal or greater than 18 years 3. Performance score less than 2 4. Patients able to tolerate breath-hold of more or equal than 15 seconds as measured by a stopwatch in the clinic 5. Signed informed consent

Exclusion criteria

Exclusion criteria: 1.Inability to hold breath in inspiration for at least 15 seconds measured by a stop watch after adequate chest physiotherapy.

Design outcomes

Primary

Measure	Time frame
Compare International Lymphoma Radiation Oncology Group (ILROG) Involved Site Radiotherapy (ISRT) versus the European Organisation of Research and Treatment of Cancer (EORTC) Involved Node Radiotherapy (INRT) volumes for mediastinal radiation in Hodgkinâ??s lymphomaTimepoint: 3 years	—

Secondary

Measure	Time frame
1. Quantify the dosimetric differences between the deep inspiration breath hold (DIBH) technique and the free breathing (FB) technique treatment plans to detect dose differences for organs at risk organs at risk from radiation, if any. 2. Paraffin block [when available] banking for future radiobiology sub-studies in context off lymphoma outcomes and late normal tissue effects. When designed, this will be re-submitted as an independent protocol in futureTimepoint: 3 years	—

Measure

Time frame

1. Quantify the dosimetric differences between the deep inspiration breath hold (DIBH) technique and the free breathing (FB) technique treatment plans to detect dose differences for organs at risk organs at risk from radiation, if any. 2. Paraffin block [when available] banking for future radiobiology sub-studies in context off lymphoma outcomes and late normal tissue effects. When designed, this will be re-submitted as an independent protocol in futureTimepoint: 3 years

—

Countries

India

Contacts

Public ContactRimpa Basu Achari

Tata Medical Center

rimpa.achari@tmckolkata.com9051584999

Outcome results