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LymphoTEC - Validation study to spare lymphocytes during radiation in genito-urinary cancers

LymphoTEC GU - A prospective validation study of dosimetric parameters for irradiation induced lymphopenia in genito-urinary cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047550
Enrollment
42
Registered
2022-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: C679- Malignant neoplasm of bladder, unspecified Health Condition 2: C61- Malignant neoplasm of prostate

Interventions

Intervention1: Computer based optimisation: LymphoTEC guideline to spare lymphocytes Duration: 5 - 6 weeks during radiotherapy Control Intervention1: NA: NA

Sponsors

Tata memorial centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of high risk localized prostate cancer receiving radiotherapy Patients of locally advanced prostate cancer receiving radiotherapy Patients of muscle invasive bladder cancer receiving pelvic radiotherapy Baseline blood lymphocyte count > 800/mm3 Patients must be >= 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

Exclusion criteria

Exclusion criteria: Patients receiving prostate only radiotherapy Patients receiving urinary bladder only radiotherapy Patients receiving hypofractionated radiotherapy Baseline lymphocyte count less than 500/mm3 Eastern Cooperative Oncology Group performance status 3 or higher Patients receiving concurrent mitomycin C, cisplatin or other chemotherapeutic agents in bladder cancer HIV positive patients and patients with immunodeficiency states Current smokers Receipt of any other investigational agents or participation in another trial protocol Excessive artifact not allowing proper contouring of target or bone marrow e.g. Hip replacement Inability to lie flat during or tolerate PET/CT, PET/MRI or SABR. Refusal to sign informed consent

Design outcomes

Primary

MeasureTime frame
Incidence of acute lymphopenia (CTCAE v5: Grade 2 or higher)Timepoint: 4 months after radiotherapy

Secondary

MeasureTime frame
naTimepoint: na

Countries

India

Contacts

Public ContactPrashanth Giridhar

Department of Radiation Oncology, Tata memorial centre, Varanasi

prashanth.jipmer@gmail.com

Outcome results

None listed

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