Urinary Bladder CancerPhase 2No AcronymNCT07184021
Neoadjuvent Dose-dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer
A Phase 2 study testing Gemcitabine and Cisplatin (DD GC) in people with Urinary Bladder Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate the feasibility, safety, and pathological response of dose-dense neoadjuvant gemcitabine and cisplatin in patients with muscle-invasive bladder cancer, with the goal of improving tumor downstaging and optimizing outcomes before radical cystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Cancer
- What is being tested?
- Gemcitabine and Cisplatin (DD GC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2025to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-T4a, N0-N1, M0.
- Eligible and fit for cisplatin-based chemotherapy (e.g., creatinine clearance ≥ 60 mL/min).
- Candidate for radical cystectomy after neoadjuvant treatment.
- ECOG performance status 0-1.
- Adequate bone marrow, liver, and renal function as per institutional standards.
Who cannot join
- Histology predominantly other than urothelial carcinoma (e.g., small cell, squamous cell ≥50%).
- Clinical or radiological evidence of distant metastases (M1).
- Prior systemic chemotherapy or radiotherapy for bladder cancer.
- Significant renal impairm ent (creatinine clearance < 60 mL/min).
- ECOG performance status ≥ 2.
- Significant comorbidities contraindicating chemotherapy (e.g., uncontrolled cardiac disease, severe infection).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Doaa Aly, Assistant professor contact
Egypt1 site
Assiut university Hospital-Departement of clinical oncology.
Asyut
Nehal Suliman, Assistant lecturer, Nehal.ali95@yahoo.com
Doaa Aly, Assistant professor, Doaaalygamaal@gmail.com
About this study
Official title: Neoadjuvent Dose-dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer:Results of a Phase 2 Trial
To evaluate the feasibility, safety, and pathological response of dose-dense neoadjuvant gemcitabine and cisplatin in patients with muscle-invasive bladder cancer, with the goal of improving tumor downstaging and optimizing outcomes before radical cystectomy.
Read the detailed description
Muscle-invasive bladder cancer (MIBC) poses a significant therapeutic challenge due to its high risk of progression and metastasis. Radical cystectomy remains the cornerstone of curative treatment; however, many patients relapse due to undetected micrometastases at diagnosis. To address this, neoadjuvant chemotherapy (NAC) with cisplatin-based combinations has been established as standard care, demonstrating improved pathological downstaging and survival outcomes compared to surgery alone (Yin et al., 2020; Necchi et al., 2017).
Gemcitabine and cisplatin (GC) is widely favored in NAC because of its comparable efficacy to older regimens and a more favorable toxicity profile (Galsky et al., 2016). However, conventional schedules may be limited by treatment delays and incomplete cycles, often due to cumulative toxicities or patient frailty. Dose-dense chemotherapy-delivering the same drugs at shorter intervals with growth factor support-has been proposed to improve outcomes by intensifying dose intensity and reducing tumor repopulation between cycles (Zargar et al., 2018; Kulkarni et al., 2020).
Evaluating dose-dense GC in the neoadjuvant setting aims to balance efficacy and tolerability, potentially increasing rates of complete pathological response and improving long-term survival. This protocol seeks to explore the feasibility, safety, and oncological benefit of this approach in patients with MIBC.
- Conditions
- Urinary Bladder Cancer
- Being tested
- Gemcitabine and Cisplatin (DD GC)
- 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.
Gemcitabine and Cisplatin (DD GC)Drug
Participants will receive neoadjuvant ddGC, consisting of gemcitabine and cisplatin administered at shortened intervals (e.g., gemcitabine 1200 mg/m² on days 1 and 8, fractionated cisplatin 35 mg/m² on day 1and 8, every 14 days) with appropriate growth factor support. A total of four cycles are planned before radical cystectomy.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Dose-Dense Gemcitabine and Cisplatin (DDGC) | Experimental | Participants will receive four cycles of dose-dense gemcitabine and cisplatin (DDGC) prior to radical cystectomy. Each cycle consists of gemcitabine 1200 mg/m² intravenously on days 1 and 8, and fractionated cisplatin 35mg/m² intravenously on day 1and 8, repeated every 14 days. Pegfilgrastim 6 mg subcutaneously will be administered on day 2 of each cycle for growth factor support. Radical cystectomy will be performed 4-6 weeks after completion of chemotherapy. Receives: Drug: Gemcitabine and Cisplatin (DD GC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pT0N0) Rate
Proportion of participants with no residual invasive or non-invasive tumor in the bladder and no lymph node involvement (ypT0N0) at the time of radical cystectomy, as determined by histopathological examination of the surgical specimen.
Measured: At the time of radical cystectomy (approximately 4-6 weeks after completion of neoadjuvant chemotherapy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Type of Study: Prospective, single-arm, interventional study evaluating the safety, feasibility, and pathological response of dose-dense neoadjuvant gemcitabine and cisplatin in muscle-invasive bladder cancer. 2.4. 2- Study Setting: Clinical Oncology department, Assiut University Hospitals 2.4. 3- Study subjects: 1. Inclusion criteria: * Histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-T4a, N0-N1, M0. * Eligible and fit for cisplatin-based chemotherapy (e.g., creatinine clearance ≥ 60 mL/min). * Candidate for radical cystectomy after neoadjuvant treatment. * ECOG performance status 0-1. * Adequate bone marrow, liver, and renal function as per institutional standards. 2. Exclusion criteria: * Histology predominantly other than urothelial carcinoma (e.g., small cell, squamous cell ≥50%). * Clinical or radiological evidence of distant metastases (M1). * Prior systemic chemotherapy or radiotherapy for bladder cancer. * Signific
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Ali Suliman, Assiut University
- Investigators
- Amal Rayan, Professor, Study director, Assiut University Hospitals, Faculty of medicine, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184021
- Sponsor's protocol ID
- Early Urinary bladder cancer
- Acronym
- No Acronym
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Because of institutional policy and patient confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvent Dose-dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer:Results of a Phase 2 Trial
- ClinicalTrials.gov ID
- NCT07184021
- Acronym / sponsor ID
- No Acronym / Early Urinary bladder cancer
- Conditions
- Urinary Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 19 Sep 2025 (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 feasibility, safety, and pathological response of dose-dense neoadjuvant gemcitabine and cisplatin in patients with muscle-invasive bladder cancer, with the goal of improving tumor downstaging and optimizing outcomes before radical cystectomy.
Detailed description
Muscle-invasive bladder cancer (MIBC) poses a significant therapeutic challenge due to its high risk of progression and metastasis. Radical cystectomy remains the cornerstone of curative treatment; however, many patients relapse due to undetected micrometastases at diagnosis. To address this, neoadjuvant chemotherapy (NAC) with cisplatin-based combinations has been established as standard care, demonstrating improved pathological downstaging and survival outcomes compared to surgery alone (Yin et al., 2020; Necchi et al., 2017).
Gemcitabine and cisplatin (GC) is widely favored in NAC because of its comparable efficacy to older regimens and a more favorable toxicity profile (Galsky et al., 2016). However, conventional schedules may be limited by treatment delays and incomplete cycles, often due to cumulative toxicities or patient frailty. Dose-dense chemotherapy-delivering the same drugs at shorter intervals with growth factor support-has been proposed to improve outcomes by intensifying dose intensity and reducing tumor repopulation between cycles (Zargar et al., 2018; Kulkarni et al., 2020).
Evaluating dose-dense GC in the neoadjuvant setting aims to balance efficacy and tolerability, potentially increasing rates of complete pathological response and improving long-term survival. This protocol seeks to explore the feasibility, safety, and oncological benefit of this approach in patients with MIBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Type of Study: Prospective, single-arm, interventional study evaluating the safety, feasibility, and pathological response of dose-dense neoadjuvant gemcitabine and cisplatin in muscle-invasive bladder cancer. 2.4. 2- Study Setting: Clinical Oncology department, Assiut University Hospitals 2.4. 3- Study subjects: 1. Inclusion criteria: * Histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-T4a, N0-N1, M0. * Eligible and fit for cisplatin-based chemotherapy (e.g., creatinine clearance ≥ 60 mL/min). * Candidate for radical cystectomy after neoadjuvant treatment. * ECOG performance status 0-1. * Adequate bone marrow, liver, and renal function as per institutional standards. 2. Exclusion criteria: * Histology predominantly other than urothelial carcinoma (e.g., small cell, squamous cell ≥50%). * Clinical or radiological evidence of distant metastases (M1). * Prior systemic chemotherapy or radiotherapy for bladder cancer. * Signific
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Dose-Dense Gemcitabine and Cisplatin (DDGC) | Experimental | Drug: Gemcitabine and Cisplatin (DD GC)Participants will receive four cycles of dose-dense gemcitabine and cisplatin (DDGC) prior to radical cystectomy. Each cycle consists of gemcitabine 1200 mg/m² intravenously on days 1 and 8, and fractionated cisplatin 35mg/m² intravenously on day 1and 8, repeated every 14 days. Pegfilgrastim 6 mg subcutaneously will be administered on day 2 of each cycle for growth factor support. Radical cystectomy will be performed 4-6 weeks after completion of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-T4a, N0-N1, M0.
- Eligible and fit for cisplatin-based chemotherapy (e.g., creatinine clearance ≥ 60 mL/min).
- Candidate for radical cystectomy after neoadjuvant treatment.
- ECOG performance status 0-1.
- Adequate bone marrow, liver, and renal function as per institutional standards.
Key exclusion criteria (6 listed)
- Histology predominantly other than urothelial carcinoma (e.g., small cell, squamous cell ≥50%).
- Clinical or radiological evidence of distant metastases (M1).
- Prior systemic chemotherapy or radiotherapy for bladder cancer.
- Significant renal impairm ent (creatinine clearance < 60 mL/min).
- ECOG performance status ≥ 2.
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 |
|---|---|---|
| Gemcitabine and Cisplatin (DD GC)Participants will receive neoadjuvant ddGC, consisting of gemcitabine and cisplatin administered at shortened intervals (e.g., gemcitabine 1200 mg/m² on days 1 and 8, fractionated cisplatin 35 mg/m² on day 1and 8, every 14 days) with appropriate growth factor support. A total of four cycles are planned before radical cystectomy. | Drug | Neoadjuvant Dose-Dense Gemcitabine and Cisplatin (DDGC) |
Primary outcome
Pathologic Complete Response (pT0N0) Rate
Time frame: At the time of radical cystectomy (approximately 4-6 weeks after completion of neoadjuvant chemotherapy).
Proportion of participants with no residual invasive or non-invasive tumor in the bladder and no lymph node involvement (ypT0N0) at the time of radical cystectomy, as determined by histopathological examination of the surgical specimen.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Assiut University HospitalsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Because of institutional policy and patient confidentiality considerations.
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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.
Doaa Aly, Assistant professor contact
Amal Rayan, Professor study director
Assiut University Hospitals, Faculty of medicine, Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine and Cisplatin (DD GC) in people with Urinary Bladder Cancer, run by Assiut University at 1 site in Egypt.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nehal Suliman, Assistant lecturer (01098019919, nehal.ali95@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pT0N0) Rate (time frame: At the time of radical cystectomy (approximately 4-6 weeks after completion of neoadjuvant chemotherapy).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2025.