Cervical CancerPhase 4NCT03206684
To Evaluate the Efficacy and Safety of PEG-rhG-CSF（Jinyouli®） in Reducing Neutropenia in Patients With Cervical Cancer
A Phase 4 study testing PEG-rhG-CSF and rhG-CSF in people with Cervical Cancer, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
A Prospective, open, randomized, controlled clinical study to evaluate the efficacy and safety of PEG-rhG-CSF(PEGylated recombinant human granulocyte stimulating factor injection) in reducing neutropenia during TP(docetaxel+cisplatin) regiment simultaneous radiochemotherapy and adjuvant chemotherapy in patients with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- PEG-rhG-CSF and rhG-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Aug 2017to Sep 2018
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18, ≤70 years old;
- Cervical cancer patients diagnosed by histopathology;
- Need to receive multi-cycle radical concurrent radiochemotherapy;
- FN risk > 20% if rhG-CSF was not accepted; High risk factors associated with FN and planed to use the same protocol in subsequent cycles(docetaxel+cisplatin regimen)；
- Performance status score(KPS)≥70;
- No obvious blood system disease,absolute neutrophil count（ANC）≥ 1.5×10^9/L, platelet count≥80×10^9 /L, hemoglobin（Hb）≥75 g/L, and no bleeding tendency;
- The patient signs the informed consent.
Who cannot join
- With infection difficult to control, or received system antibiotic treatment within 72 h before chemotherapy;
- Any bone marrow abnormalities and other hematopoietic ;
- Had received bone marrow or hematopoietic stem cell transplantation within 3 months;
- with other malignancies not cure, or with brain metastases;
- Liver function tests:total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≥2.5 times normal upper limit.
- Renal function tests: serum creatinine (Cr)> 1.5 times normal upper limit;
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- Allergic to the drugs or other genetic engineering biological products from Escherichia coli;
- Suffering from mental or neurological disorders;
- Investigator think it is not suitable for recruiting.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Mei Shi, MD, +86-029-84775425, Shimei82@gmail.com
About this study
Official title: A Prospective, Open, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF in Reducing Neutropenia in Patients With Cervical Cancer
A Prospective, open, randomized, controlled clinical study to evaluate the efficacy and safety of PEG-rhG-CSF(PEGylated recombinant human granulocyte stimulating factor injection) in reducing neutropenia during TP(docetaxel+cisplatin) regiment simultaneous radiochemotherapy and adjuvant chemotherapy in patients with cervical cancer
- Conditions
- Cervical Cancer
- Being tested
- PEG-rhG-CSF, rhG-CSF
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
Also called PEG-rhG-CSF single-dose administered
PEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy，weight ≥ 45kg were given 6mg once per chemotherapy cycle, weight <45kg were given 3mg once per chemotherapy cycle.
rhG-CSFDrug
Also called rhG-CSF daily administered
rhG-CSF was administered subcutaneously 48h after chemotherapy，weight≥45kg were given 300μg/d, weight<45kg were given 150μg/d,continuous injection for 3-5 days until the absolute neutrophils count≥2×10^9/L.
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF | Experimental | PEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy，with patients' weight ≥ 45kg were given 6mg once per chemotherapy cycle, weight <45kg were given 3mg once per chemotherapy cycle. Receives: Drug: PEG-rhG-CSF |
| rhG-CSF | Active comparator | rhG-CSF was daily administered subcutaneously 48h after chemotherapy，weight≥45kg were given 300μg/d, weight<45kg were given 150μg/d,continuous injection for 3-5 days until the absolute neutrophils count≥2×10^9/L. Receives: Drug: rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of III/IV neutropenia
The incidence of III/IV neutropenia in each chemotherapy cycle
Measured: 3 months
Secondary outcomes (2)
Incidence of FN
Incidence of febrile neutropenia (FN) in each chemotherapy cycle
Measured: 3 months
Proportion of chemotherapy dose adjustment
Proportion of chemotherapy dose adjustment due to neutropenia
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startAug 2017 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Shi, Air Force Military Medical University, China
- Investigators
- Mei Shi, MD, Principal investigator, Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206684
- Sponsor's protocol ID
- CSPC-JYL-CC-01
- Status last verified
- Aug 2017
- First submitted
- 30 Jun 2017
- Last updated
- 28 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF in Reducing Neutropenia in Patients With Cervical Cancer
- ClinicalTrials.gov ID
- NCT03206684
- Acronym / sponsor ID
- CSPC-JYL-CC-01
- Conditions
- Cervical Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 2 Jul 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.
A Prospective, open, randomized, controlled clinical study to evaluate the efficacy and safety of PEG-rhG-CSF(PEGylated recombinant human granulocyte stimulating factor injection) in reducing neutropenia during TP(docetaxel+cisplatin) regiment simultaneous radiochemotherapy and adjuvant chemotherapy in patients with cervical cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF | Experimental | Drug: PEG-rhG-CSFPEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy，with patients' weight ≥ 45kg were given 6mg once per chemotherapy cycle, weight <45kg were given 3mg once per chemotherapy cycle. |
| rhG-CSF | Active comparator | Drug: rhG-CSFrhG-CSF was daily administered subcutaneously 48h after chemotherapy，weight≥45kg were given 300μg/d, weight<45kg were given 150μg/d,continuous injection for 3-5 days until the absolute neutrophils count≥2×10^9/L. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18, ≤70 years old;
- Cervical cancer patients diagnosed by histopathology;
- Need to receive multi-cycle radical concurrent radiochemotherapy;
- FN risk > 20% if rhG-CSF was not accepted; High risk factors associated with FN and planed to use the same protocol in subsequent cycles(docetaxel+cisplatin regimen)；
- Performance status score(KPS)≥70;
Key exclusion criteria (9 listed)
- With infection difficult to control, or received system antibiotic treatment within 72 h before chemotherapy;
- Any bone marrow abnormalities and other hematopoietic ;
- Had received bone marrow or hematopoietic stem cell transplantation within 3 months;
- with other malignancies not cure, or with brain metastases;
- Liver function tests:total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≥2.5 times normal upper limit.
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 |
|---|---|---|
| PEG-rhG-CSFAlso: PEG-rhG-CSF single-dose administeredPEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy，weight ≥ 45kg were given 6mg once per chemotherapy cycle, weight <45kg were given 3mg once per chemotherapy cycle. | Drug | PEG-rhG-CSF |
| rhG-CSFAlso: rhG-CSF daily administeredrhG-CSF was administered subcutaneously 48h after chemotherapy，weight≥45kg were given 300μg/d, weight<45kg were given 150μg/d,continuous injection for 3-5 days until the absolute neutrophils count≥2×10^9/L. | Drug | rhG-CSF |
Primary outcome
Incidence of III/IV neutropenia
Time frame: 3 months
The incidence of III/IV neutropenia in each chemotherapy cycle
2 secondary outcomes
Incidence of FN
Time frame: 3 months
Proportion of chemotherapy dose adjustment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
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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.
Mei Shi, MD principal investigator
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PEG-rhG-CSF and rhG-CSF in people with Cervical Cancer, run by Air Force Military Medical University, China 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 7 inclusion and 9 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 28 Aug 2017. 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. 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 Mei Shi, MD (+86-29-84775425, Shimei82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of III/IV neutropenia (time frame: 3 months). 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 28 Aug 2017.