Chemotherapy EffectPhase 3NCT04255771
A Study of Postoperative Adjuvant Chemotherapy for Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion
A Phase 3 study testing Gemcitabine in people with Chemotherapy Effect, run by Qinghua Xia,Prof at 1 site in China.
Trial summary
This project is to explore the effect of adjuvant chemotherapy on total tumor survival time, progression-free survival time, and recurrence-free survival time in patients with pTanyN0M0 upper urinary urothelial carcinoma with lymphatic vascular invasion (LVI) through a prospective case-control study. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Chemotherapy Effect
- What is being tested?
- Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 1 Jun 2023
- Phase
- Phase 3
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20-85 years;
- ECOG score 0-1 points;
- Patients with UTUC, undergoing radical nephrectomy, pathological staging For pTanyN0M0;
- Patients voluntarily signed informed consent.
Who cannot join
- Obvious cardiopulmonary dysfunction, serious diabetes and other chronic diseases;
- Obvious chemotherapy contraindications;
- Patients have a history of other organ malignancies;
- Combined with tumors of other sites.
Trial locations and contacts
1 site in 1 country.
China1 site
Shandong Provincial Hospital
Jinan, Shandong, 250021
Qinghua Xia,Prof, professor, 0086053168773146 ext. 3147, phsandi@126.com
About this study
Official title: A Prospective Randomized Controlled Trial for Postoperative Adjuvant Chemotherapy for pTanyN0M0 Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion
This project is to explore the effect of adjuvant chemotherapy on total tumor survival time, progression-free survival time, and recurrence-free survival time in patients with pTanyN0M0 upper urinary urothelial carcinoma with lymphatic vascular invasion (LVI) through a prospective case-control study.
Read the detailed description
This project is to explore the effect of adjuvant chemotherapy on total tumor survival time, progression-free survival time, and recurrence-free survival time in patients with pTanyN0M0 upper urinary urothelial carcinoma with lymphatic vascular invasion (LVI) through a prospective case-control study. Therapeutic value of adjuvant chemotherapy for LVI(+) patients with pT1N0M0, pT2N0M0, and pT3-4N0M0 upper urinary urothelial carcinoma, respectively.
- Conditions
- Chemotherapy Effect
- Being tested
- Gemcitabine, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Cisplatin
Standard GC (gemcitabine and cisplatin) regimen: gemcitabine 1000-1200mg/m2 intravenous infusion on days 1 and 8, cisplatin 70mg/m2 on the second day of intravenous infusion, every 3 weeks (21-day regimen) is a cycle, A total of 3 cycles.
PlacebosDrug
Also called Placebo
Use a placebo as a comparison
| Study group | Role | What they receive |
|---|---|---|
| Effect of adjuvant chemotherapy on pTanyN0M0 UTUC with LVI | Experimental | This project is to explore the effect of adjuvant chemotherapy on total tumor survival time, progression-free survival time, and recurrence-free survival time in patients with pTanyN0M0 upper urinary urothelial carcinoma with lymphatic vascular invasion (LVI) through a prospective case-control study. Therapeutic value of adjuvant chemotherapy for LVI(+) patients with pT1N0M0, pT2N0M0, and pT3-4N0M0 upper urinary urothelial carcinoma, respectively. Receives: Drug: Gemcitabine |
| Effect of placebo on pTanyN0M0 UTUC with lymphatic invasion | Placebo comparator | As a control, this clinical trial also set up a placebo control group. The effect of adjuvant chemotherapy was obtained by random grouping and comparing the effects of patients in the experimental group and the control group. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total tumor survival time
Effect of postoperative adjuvant chemotherapy on total tumor survival time
Measured: 3 years
Secondary outcomes (1)
progression-free survival time
Effect of postoperative adjuvant chemotherapy on progression-free survival time
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy EffectStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qinghua Xia,Prof
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Qinghua Xia,Prof, Shandong Provincial Hospital
- Investigators
- Qinghua Xia, Prof, Study director, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255771
- Sponsor's protocol ID
- ShandongPH Urology
- Status last verified
- Feb 2020
- First submitted
- 21 Jan 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial for Postoperative Adjuvant Chemotherapy for pTanyN0M0 Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion
- ClinicalTrials.gov ID
- NCT04255771
- Acronym / sponsor ID
- ShandongPH Urology
- Conditions
- Chemotherapy Effect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qinghua Xia,ProfOther government
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 5 Feb 2020 (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.
This project is to explore the effect of adjuvant chemotherapy on total tumor survival time, progression-free survival time, and recurrence-free survival time in patients with pTanyN0M0 upper urinary urothelial carcinoma with lymphatic vascular invasion (LVI) through a prospective case-control study.
Detailed description
This project is to explore the effect of adjuvant chemotherapy on total tumor survival time, progression-free survival time, and recurrence-free survival time in patients with pTanyN0M0 upper urinary urothelial carcinoma with lymphatic vascular invasion (LVI) through a prospective case-control study. Therapeutic value of adjuvant chemotherapy for LVI(+) patients with pT1N0M0, pT2N0M0, and pT3-4N0M0 upper urinary urothelial carcinoma, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effect of adjuvant chemotherapy on pTanyN0M0 UTUC with LVI | Experimental | Drug: GemcitabineThis project is to explore the effect of adjuvant chemotherapy on total tumor survival time, progression-free survival time, and recurrence-free survival time in patients with pTanyN0M0 upper urinary urothelial carcinoma with lymphatic vascular invasion (LVI) through a prospective case-control study. Therapeutic value of adjuvant chemotherapy for LVI(+) patients with pT1N0M0, pT2N0M0, and pT3-4N0M0 upper urinary urothelial carcinoma, respectively. |
| Effect of placebo on pTanyN0M0 UTUC with lymphatic invasion | Placebo comparator | Drug: PlacebosAs a control, this clinical trial also set up a placebo control group. The effect of adjuvant chemotherapy was obtained by random grouping and comparing the effects of patients in the experimental group and the control group. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 20-85 years;
- ECOG score 0-1 points;
- Patients with UTUC, undergoing radical nephrectomy, pathological staging For pTanyN0M0;
- Patients voluntarily signed informed consent.
Key exclusion criteria (4 listed)
- Obvious cardiopulmonary dysfunction, serious diabetes and other chronic diseases;
- Obvious chemotherapy contraindications;
- Patients have a history of other organ malignancies;
- Combined with tumors of other sites.
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 |
|---|---|---|
| GemcitabineAlso: CisplatinStandard GC (gemcitabine and cisplatin) regimen: gemcitabine 1000-1200mg/m2 intravenous infusion on days 1 and 8, cisplatin 70mg/m2 on the second day of intravenous infusion, every 3 weeks (21-day regimen) is a cycle, A total of 3 cycles. | Drug | Effect of adjuvant chemotherapy on pTanyN0M0 UTUC with LVI |
| PlacebosAlso: PlaceboUse a placebo as a comparison | Drug | Effect of placebo on pTanyN0M0 UTUC with lymphatic invasion |
Primary outcome
Total tumor survival time
Time frame: 3 years
Effect of postoperative adjuvant chemotherapy on total tumor survival time
1 secondary outcome
progression-free survival time
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
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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. This study is not recruiting at the moment.
Qinghua Xia, Prof study director
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemcitabine in people with Chemotherapy Effect, run by Qinghua Xia,Prof at 1 site in China.
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 4 inclusion and 4 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 18 Feb 2020. 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 China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total tumor survival time (time frame: 3 years). 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 18 Feb 2020.