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A study to assess the feasibility of decreased duration of treatment in bladder cancer in Indian setting

Hypo-fractionated Radical radiotherapy in Muscle Invasive Bladder Cancer: A Feasibility Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047509
Enrollment
15
Registered
2022-11-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Interventions

Intervention1: Radiation therapy: Radiotherapy dose: 55Gy in 20 fractions over 4 weeks As this is a single arm study, comparator agent is not applicable Intervention2: Radiation therapy: Radiotherapy

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically proven muscle-invasive bladder cancers with/ without clinically positive pelvic and paraaortic lymph nodes on imaging 2. No distant visceral or bony metastases 3. Planned for definitive radiotherapy with or without concurrent chemotherapy [Medically inoperable, refuses surgery]

Exclusion criteria

Exclusion criteria: 1. History of prior radiotherapy to the pelvis 2. Pregnant or lactating women 3. Poor ECOG performance status [3/4]

Design outcomes

Primary

MeasureTime frame
To assess the feasibility and early toxicity of radical hypo-fractionated radiotherapy with or without concurrent chemotherapy in patients with non-metastatic muscle invasive bladder cancers.Timepoint: 3 months of completion of radiation therapy

Secondary

MeasureTime frame
To assess locoregional controlTimepoint: 1 year

Countries

India

Contacts

Public ContactKannan Periasamy

PGIMER

pkannan10011988@gmail.com9442395508

Outcome results

None listed

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