Urinary Bladder CancerNCT04812145
Role of Hypofractionated Radiotherapy With Concurrent Gemcitabine in Treatment of Urinary Bladder Carcinoma
An observational study of Urinary Bladder Cancer, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Bladder Cancer
- What is being tested?
- Chemoradiation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Urinary bladder cancer patient histologically proved Transitional cell carcinoma received concurrent chemoradiation with gemcaitabine
Who may be able to join
- Pathologically confirmation of transitional cell carcinoma . Non metastatic invasive bladder cancer (TNM0) Any age group ≥ 18 years. Non pregnant female patients.
Who cannot join
- Other pathology than Transitional cell carcinoma Metastatic Patient Age less than 18 years
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Urinary Bladder Cancer
- Being tested
- Chemoradiation
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoradiationRadiation
Hypofractionated radiotherapy with concurrent Gemcitabine
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to hypofractionated radiotherapy concurrent with Gemcitabine in urinary bladder cancer
Estimate Disease free survival .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mostafa Abdelzaher Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812145
- Sponsor's protocol ID
- U.Bladder Cancer Radiotherapy
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Hypofractionated Radiotherapy With Concurrent Gemcitabine in Treatment of Urinary Bladder Carcinoma
- ClinicalTrials.gov ID
- NCT04812145
- Acronym / sponsor ID
- U.Bladder Cancer Radiotherapy
- Conditions
- Urinary Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Urinary bladder cancer patient histologically proved Transitional cell carcinoma received concurrent chemoradiation with gemcaitabine
Key inclusion criteria (1 listed)
- Pathologically confirmation of transitional cell carcinoma . Non metastatic invasive bladder cancer (TNM0) Any age group ≥ 18 years. Non pregnant female patients.
Key exclusion criteria (1 listed)
- Other pathology than Transitional cell carcinoma Metastatic Patient Age less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemoradiationHypofractionated radiotherapy with concurrent Gemcitabine | Radiation | – |
Primary outcome
Response to hypofractionated radiotherapy concurrent with Gemcitabine in urinary bladder cancer
Time frame: baseline
Estimate Disease free survival .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background1. 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.
Related trials for Urinary Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Mostafa Abdelzahir, Master degree (+201093534631, Essra.mostafa1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to hypofractionated radiotherapy concurrent with Gemcitabine in urinary bladder cancer (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04812145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.