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A prospective single arm study of cytokine analyses in evaluation of radiation induced lymphopenia in cancers

LymphoTEC2- A prospective single arm phase 2 study of cytokine analyses in evaluation of radiation induced lymphopenia in cancers - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076208
Enrollment
88
Registered
2024-11-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: C340- Malignant neoplasm of main bronchus Health Condition 2: C103- Malignant neoplasm of posterior wall of oropharynx Health Condition 3: C61- Malignant neoplasm of prostate

Interventions

Intervention1: LymphoTEC guideline based constraint to heart, lung, bone, spleen: LymphoTEC guideline based constraint to heart, lung, bone, spleen Duration of intervention: 5 - 7 weeks Frequency : Da

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients receiving external beam radiotherapy only with curative intent to head and neck, central nervous system, abdomen, thorax or pelvis for malignancy Equivalent dose of 2 Gy EQD2 of radiotherapy planned is to be higher or equal to 50 Gy All relevant LymphoTEC guidelines dose constraints to be met during planning Baseline blood lymphocyte count more than 800/mm3 Patients must be more than 18 years of age, have the ability to understand, and the willingness to sign a written informed consent document. Patients must have an Eastern Cooperative Oncology Group performance status less than or equal to 2

Exclusion criteria

Exclusion criteria: Lymphocyte count less than 800 Eastern Cooperative Oncology Group performance status 3 or higher Patients receiving concurrent chemotherapy, immunotherapy or concurrent hormonal therapy (Eg: Androgen deprivation therapy) Patients receiving radiotherapy with a palliative intent Patients receiving radiotherapy to a EQD2 of less than 50 Gy

Design outcomes

Primary

MeasureTime frame
•Correlate serum levels of cytokines IL7, IL 15 and TGF beta at baseline with incidence of acute lymphopenia (within 4 months of radiotherapy) (CTCAE v5: Grade 3 or higher)Timepoint: Baseline 3 weeks of radiotherapy—

Secondary

MeasureTime frame
• Evaluate serum levels of IL7 and IL15 at onset of acute Grade 3 or higher lymphopenia for presence or absence of compensatory increaseTimepoint: 2 months—

Countries

India

Contacts

Public ContactPrashanth G

Tata Memorial centre

prashanth.jipmer@gmail.com08098281729

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026