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Radiation Treatment Of Bladder Cancer With Tomotherapy/ Intensity Modulated Radio Therapy (IMRT)

Feasibility Study Evaluating Bladder Preservation By Helical Tomotherapy Based IMRT In Muscle Invasive Bladder Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000559
Enrollment
20
Registered
2009-09-14
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- Muscle Invasive Bladder Cancer

Interventions

Intervention1: Tomotherapy based IMRT: Tomotherapy based IMRT, to a dose of 64Gy in 32# to the whole bladder. Simultaneous Integrated Boost to the tumour bed and concomittant chemotherapy with weekly

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ? Age > 18 years old: Male and Female ? Histologically proven invasive bladder transitional cell carcinoma ? AJCC clinical stages T2-T4a, Nx or N0, M0 ? Thorough evaluation by a urologist and have undergone as thorough a TURBT as is judged safely possible ? KPS>= 70 ? Able to tolerate systemic chemotherapy combined with pelvic radiation therapy by the joint agreement of the participating Urologist, Radiation Oncologist and Medical Oncologist. ? Hemoglobin >= 10 mg/dl, WBC >= 3000/ml, Absolute neutrophil count of >= 1800/ml, Platelet count of >= 100,000/mm3, Serum creatinine < 1.5 mg%, Serum bilirubin of 2.0mg% ? Ability to take daily treatment ? Only patients with a solitary, well defined tumour will be considered for the boost protocol ? Protocol treatment to begin a maximum of 30 days following TURBT

Exclusion criteria

Exclusion criteria: Prior pelvic radiation therapy. ? Incontinence, need for cathererisation ? Hydronephrosis attributable to the tumour ? Pregnancy ? Previous malignancy that is likely to interfere with protocol treatment ? Inflammatory bowel disease

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is to assess the Dosimetric evaluation of Intensity Modulated Radiotherapy treatment for whole and partial Bladder radiotherapy. , novel Adaptive Radiotherapy Technique and set up errors and Internal organ motion with IGRT.Timepoint: NA

Secondary

MeasureTime frame
The secondary outcome of the study is to assess the acute and late toxicity, local control and bladder preservation rate.Timepoint: NA

Countries

India

Contacts

Public ContactDr Vedang Murthy

ACTREC, Tata Memorial Centre

vmurthy@actrec.gov.in02227405000

Outcome results

None listed

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