Role of Hypofractionated Radiotherapy With Concurrent Gemcitabine in Treatment of Urinary Bladder Carcinoma
1 other identifier
observational
50
0 countries
N/A
Brief Summary
Estimate the response to modified hypofractionated radiotherapy concurrent with Gemcitabine in urinary bladder cancer patients . Estimate local control, relapse free survival, overall survival and bladder preservation rate. Evaluate the toxicity of a modified hypofractionated chemoradiotherapy protocol for patients with invasive bladder cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2021
CompletedFirst Posted
Study publicly available on registry
March 23, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedMarch 23, 2021
March 1, 2021
1.8 years
March 19, 2021
March 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Response to hypofractionated radiotherapy concurrent with Gemcitabine in urinary bladder cancer
Estimate Disease free survival .
baseline
Interventions
Hypofractionated radiotherapy with concurrent Gemcitabine
Eligibility Criteria
Urinary bladder cancer patient histologically proved Transitional cell carcinoma received concurrent chemoradiation with gemcaitabine
You may qualify if:
- \- Pathologically confirmation of transitional cell carcinoma . Non metastatic invasive bladder cancer (TNM0) Any age group ≥ 18 years. Non pregnant female patients.
You may not qualify if:
- \- Other pathology than Transitional cell carcinoma Metastatic Patient Age less than 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
1. Siegel, R.L., K.D. Miller, and A. Jemal, Cancer statistics, 2019. CA: a cancer journal for clinicians, 2019. 69(1): p. 7-34. 2. Staerkel,Ro, J.Y., G.A. andAyala, A.G. Cytologic and histologic features of superficial bladder cancer. The Urologic clinics of North America, 1992. 19(3): p. 435-453. 3. Witjes, J.A., T. Lebret, E.M. Compérat, N.C. Cowan, M. De Santis, H.M. Bruins, et al., Updated 2016 EAU guidelines on muscle-invasive and metastatic bladder cancer. European urology, 2017. 71(3): p. 462-475. 4. De Santis, M. Bachner , M. Cerveny, et al. Combined chemoradiotherapy with gemcitabine in patients with locally advanced inoperable transitional cell carcinoma of the urinary bladder and/or in patients ineligible for surgery: a phase I trial. Ann Oncol, 25 (2014), pp. 1789-1794. 5. Kimura, T., H. Ishikawa, T. Kojima, S. Kandori, T. Kawahara, Y. Sekino, et al., Bladder preservation therapy for muscle invasive bladder cancer: the past, present and future. Japanese Journal of Clinical Oncology, 2020. 50(10): p. 1097-1107. 6. Flaig, T.W., P.E. Spiess, N. Agarwal, R. Bangs, S.A. Boorjian, M.K. Buyyounouski, et al., NCCN guidelines insights: bladder cancer, version 5.2018. Journal of the National Comprehensive Cancer Network, 2018. 16(9): p. 1041-1053. 7. Mitin, T., A. George, A.L. Zietman, N.M. Heney, D.S. Kaufman, R.G. Uzzo, et al., Long-term outcomes among patients who achieve complete or near-complete responses after the induction phase of bladder-preserving combined-modality therapy for muscle-invasive bladder cancer: a pooled analysis of NRG Oncology/RTOG 9906 and 0233. International Journal of Radiation Oncology* Biology* Physics, 2016. 94(1): p. 67-74. 8. Mak, K.S., A.B. Smith, A. Eidelman, R. Clayman, A. Niemierko, J.-S. Cheng, et al., Quality of life in long-term survivors of muscle-invasive bladder cancer. International Journal of Radiation Oncology* Biology* Physics, 2016. 96(5): p. 1028-1036. 9. Azria, D., O. Riou, X. Rebillard, S. Thezenas, R. Thuret, P. Fenoglietto, et al., Combined chemoradiation therapy with twice-weekly gemcitabine and cisplatin for organ preservation in muscle-invasive bladder cancer: long-term results of a phase 1 trial. International Journal of Radiation Oncology* Biology* Physics, 2014. 88(4): p. 853-859. 10. Shipley, W.U., G.R. Prout, A.B. Einstein, L.J. Coombs, Z. Wajsman, M.S. Soloway, et al., Treatment of invasive bladder cancer by cisplatin and radiation in patients unsuited for surgery. Jama, 1987. 258(7): p. 931-935. 11. Borut K, Lijana ZK. Phase I study of radiochemothearpy with gemcitabine in invasive bladder cancer. RadiotherOncol 2012;102:412-5.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 19, 2021
First Posted
March 23, 2021
Study Start
April 1, 2021
Primary Completion
January 1, 2023
Study Completion
April 1, 2023
Last Updated
March 23, 2021
Record last verified: 2021-03