Bladder CancerPhase 4NCT03274284
Chemoradiotherapy for Recurrent T1G3 Bladder Cancer
A Phase 4 study testing chemoradiation in people with Bladder Cancer, run by Assiut University.
Trial summary
To evaluate the short term results of chemoradiation in case of T1G3 BC after BCG failure. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- chemoradiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Dec 2019
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with recurrent T1G3 bladder cancer after 6 doses of BCG consenting for chemoradiation and refusing radical cystectomy
Who cannot join
- Any patients with distant metastasis or positive LN on CT or MRI.
- Patients unfit for chemoradiation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Chemoradiotherapy for Recurrent T1G3 Bladder Cancer After BCG Failure
To evaluate the short term results of chemoradiation in case of T1G3 BC after BCG failure.
Read the detailed description
Non- muscle invasive bladder cancer (NMIBC) is a heterogeneous group of cancers. For most urologists the treatment of T1G3 tumor poses a dilemma of management.The spectrum of clinical behavior includes; T1 lesions that will not progress however T1G3 may be potentially lethal, associated with metastatic disease at the time of presentation.
The major goal of treatment for T1G3 BC should be bladder preservation whenever possible.
Intravesical therapy with Bacille Calmette Guerin (BCG) may decrease the recurrence rate by compared with transurethral resection of bladder tumor (TURBT) alone.
- Conditions
- Bladder Cancer
- Being tested
- chemoradiation
- Keywords
- chemoradiation for, T1G3 BC
- 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.
chemoradiationCombination product
chemoradiation in case of T1G3 BC after BCG failure.
| Study group | Role | What they receive |
|---|---|---|
| chemoradiotherapy | Experimental | Chemoradiation in the form of cisplatin plus conformal radiotherapy 55GY/20 fractions which is biologically effective to 64GY/32 fractions fr Receives: Combination Product: chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result of chemoradiation for recurrentT1G3 BC after BCG failure
treatment of 20 patients with recurrent T1G3
BC by chemoradiation to see efficacy and safety .and to reduce the number of recurrent cases and improve survival.
Measured: followup within two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study startOct 2017 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MokhtarDawood, Assiut University
- Investigators
- Ahmed Moeen, Study director, Moeen3@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274284
- Sponsor's protocol ID
- Bl Cancer
- Status last verified
- Sep 2017
- First submitted
- 29 Aug 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lambert EH, Pierorazio PM, Olsson CA, Benson MC, McKiernan JM, Poon S. The increasing use of intravesical therapies for stage T1 bladder cancer coincides with decreasing survival after cystectomy. BJU Int. 2007 Jul;100(1):33-6. doi: 10.1111/j.1464-410X.2007.06912.x.
PubMed 17552951Soloway MS, Sofer M, Vaidya A. Contemporary management of stage T1 transitional cell carcinoma of the bladder. J Urol. 2002 Apr;167(4):1573-83.
PubMed 11912367
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoradiotherapy for Recurrent T1G3 Bladder Cancer After BCG Failure
- ClinicalTrials.gov ID
- NCT03274284
- Acronym / sponsor ID
- Bl Cancer
- Conditions
- Bladder Cancer
- Keywords
- chemoradiation for, T1G3 BC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Sep 2017 (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.
To evaluate the short term results of chemoradiation in case of T1G3 BC after BCG failure.
Detailed description
Non- muscle invasive bladder cancer (NMIBC) is a heterogeneous group of cancers. For most urologists the treatment of T1G3 tumor poses a dilemma of management.The spectrum of clinical behavior includes; T1 lesions that will not progress however T1G3 may be potentially lethal, associated with metastatic disease at the time of presentation.
The major goal of treatment for T1G3 BC should be bladder preservation whenever possible.
Intravesical therapy with Bacille Calmette Guerin (BCG) may decrease the recurrence rate by compared with transurethral resection of bladder tumor (TURBT) alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemoradiotherapy | Experimental | Combination Product: chemoradiationChemoradiation in the form of cisplatin plus conformal radiotherapy 55GY/20 fractions which is biologically effective to 64GY/32 fractions fr |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with recurrent T1G3 bladder cancer after 6 doses of BCG consenting for chemoradiation and refusing radical cystectomy
Key exclusion criteria (2 listed)
- Any patients with distant metastasis or positive LN on CT or MRI.
- Patients unfit for chemoradiation
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 |
|---|---|---|
| chemoradiationchemoradiation in case of T1G3 BC after BCG failure. | Combination product | chemoradiotherapy |
Primary outcome
Result of chemoradiation for recurrentT1G3 BC after BCG failure
Time frame: followup within two years
treatment of 20 patients with recurrent T1G3 BC by chemoradiation to see efficacy and safety .and to reduce the number of recurrent cases and improve survival.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Background: PubMed 17552951Lambert EH, Pierorazio PM, Olsson CA, Benson MC, McKiernan JM, Poon S. The increasing use of intravesical therapies for stage T1 bladder cancer coincides with decreasing survival after cystectomy. BJU Int. 2007 Jul;100(1):33-6. doi: 10.1111/j.1464-410X.2007.06912.x.
- Background: PubMed 11912367Soloway MS, Sofer M, Vaidya A. Contemporary management of stage T1 transitional cell carcinoma of the bladder. J Urol. 2002 Apr;167(4):1573-83.
Related trials for Bladder Cancer
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer
RecruitingObservational study
En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
Bladder Cancer
RecruitingObservational study
Gender Related Coping and Survivorship for Genitourinary Cancers
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
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.
Ahmed Moeen study director
Moeen3@yahoo.com
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing chemoradiation in people with 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 2 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 11 Sep 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 moktar dawood (+201009442860, mokhtardawood@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result of chemoradiation for recurrentT1G3 BC after BCG failure (time frame: followup within two years). 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 NCT03274284, which also lists 2 linked publications.
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 11 Sep 2017; AzTrials last refreshed its copy on 30 Oct 2026.