Adjuvant ChemotherapyPhase 4NCT03858166
Efficacy and Safety of PEG-rhG-CSF Secondary Prophylaxis vs. Therapeutic Administration in Patients With Ovarian Cancer
A Phase 4 study testing PEG-rhG-CSF in people with Adjuvant Chemotherapy and Ovarian Neoplasms, run by Shandong University at 1 site in China.
Trial summary
This study is a multicenter, open-label, randomized clinical trial. Patients with ovarian cancer receiving postoperative adjuvant chemotherapy were eligible to enroll in this study. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Adjuvant Chemotherapy, Ovarian Neoplasms, Ovarian Cancer
- What is being tested?
- PEG-rhG-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 31 Dec 2020
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Histopathology or cytology and immunomolecular biology diagnosed with ovarian cancer
- Grade 3/4 neutropenia appeared in previous chemotherapy
- accept at least 3 cycles of adjuvant chemotherapy
- expected survival time ≥ 8 months; KPS>70
- Normal bone marrow hematopoietic function: ANC≥1.5×109/L, PLT≥80×109/L, Hb≥75g/L, WBC ≥3.0×109/L
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- No obvious abnormalities in electrocardiogram examination, no obvious cardiac dysfunction
- Liver function: ALT, TBIL, AST <= 2.5 ULN
- Renal function: Cr, BUN <= 1.5 ULN
- All patients must agree to take effective contraceptive measures during the study and within 6 months after discontinuing the treatment. Females of childbearing age must be negative in urinary pregnancy test before the treatment.
- Before the start of the study, all patients have been fully understood the research and the must sign the informed consent.
Who cannot join
- Uncontrolled infection, temperature≥38℃
- patients with bone marrow dysplasia and other hematopoietic dysfunction , or accepted stem cell or bone marrow transplant in 3 months before recruitment
- undergoing any other clinical trial in 4 weeks before recruitment
- undergoing radiotherapy in 4 weeks before recruitment
- Patients with other malignant tumors who have not been cured or have brain metastasis
- Liver function: ALT, TBIL, AST > 2.5 ULN; If due to liver metastasis, ALT, TBIL, AST > 5 ULN; Renal function: Cr>1.5; Obvious abnormalities in electrocardiogram
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- Severe heart, kidney, liver and other important organs chronic diseases
- severe and uncontrolled diabetes
- Pregnancy or lactation in women or women of childbearing age refused to accept contraception
- People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products
- Suspected or confirmed drug use, drug abuse, alcoholics
- Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation
- HIV positive
- Syphilis infection
- The investigator believes that the patient's condition is not suitable for this clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Secondary Prophylaxis Versus ANC< 1000/mm3 Administration of PEG-rhG-CSF in Patients Receiving Cytotoxic Chemotherapy for Gynecologic Malignancies
This study is a multicenter, open-label, randomized clinical trial. Patients with ovarian cancer receiving postoperative adjuvant chemotherapy were eligible to enroll in this study. Eligible patients were randomly allocated in a "1:1" to "Standard group" ( 6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy) and "Adjusted group" (6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy). All patients need to receive at least 2 cycles of PEG-rhG-CSF administration. The primary outcome is the incidence of grade 3/4 neutropenia, and the duration of grade 3/4 neutropenia, the second outcomes are the incidence of FN, neutropenia-related hospitalization, incidence of reduction and delay of chemotherapy dose and safety of PEG-rhG-CSF.
Read the detailed description
Patients with ovarian cancer receiving postoperative adjuvant chemotherapy were recruited and randomly allocated in a "1:1" to "Standard group" (6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy) and "Adjusted group" (6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy). Eligible patients enrolled in this study need to receive 6 cycles of docetaxel or paclitaxel (including liposome paclitaxel) and carboplatin on day 1, every 3 weeks. All patients need to receive at least 2 cycles of PEG-rhG-CSF administration. The primary outcome is the incidence of grade 3/4 neutropenia, and the duration of grade 3/4 neutropenia, the second outcomes are the incidence of FN, neutropenia-related hospitalization, incidence of reduction and delay of chemotherapy dose and safety of PEG-rhG-CSF.
- Conditions
- Adjuvant Chemotherapy, Ovarian Neoplasms, Ovarian Cancer
- Being tested
- PEG-rhG-CSF
- Keywords
- PEG-rhG-CSF, secondary prophylaxis
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
6mg PEG-rhG-CSF was administrated subcutaneously at different time after chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Active comparator | 6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy. Receives: Drug: PEG-rhG-CSF |
| Adjusted group | Experimental | 6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy. Receives: Drug: PEG-rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 3/4 neutropenia
Incidence of grade 3/4 neutropenia
Measured: At the end of cycle 2 (each cycle is 21 days)
The duration of grade 3/4 neutropenia
The duration of grade 3/4 neutropenia
Measured: At the end of cycle 2 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Dec 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: Sponsor Termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjuvant ChemotherapyStudies 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beihua Kong, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858166
- Sponsor's protocol ID
- WJW-2-PEG-OC
- Status last verified
- Jan 2024
- First submitted
- 25 Feb 2019
- Last updated
- 5 Jan 2024
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Secondary Prophylaxis Versus ANC< 1000/mm3 Administration of PEG-rhG-CSF in Patients Receiving Cytotoxic Chemotherapy for Gynecologic Malignancies
- ClinicalTrials.gov ID
- NCT03858166
- Acronym / sponsor ID
- WJW-2-PEG-OC
- Conditions
- Adjuvant Chemotherapy, Ovarian Neoplasms, Ovarian Cancer
- Keywords
- PEG-rhG-CSF, secondary prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Termination
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Feb 2019 (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 study is a multicenter, open-label, randomized clinical trial. Patients with ovarian cancer receiving postoperative adjuvant chemotherapy were eligible to enroll in this study. Eligible patients were randomly allocated in a "1:1" to "Standard group" ( 6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy) and "Adjusted group" (6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy). All patients need to receive at least 2 cycles of PEG-rhG-CSF administration. The primary outcome is the incidence of grade 3/4 neutropenia, and the duration of grade 3/4 neutropenia, the second outcomes are the incidence of FN, neutropenia-related hospitalization, incidence of reduction and delay of chemotherapy dose and safety of PEG-rhG-CSF.
Detailed description
Patients with ovarian cancer receiving postoperative adjuvant chemotherapy were recruited and randomly allocated in a "1:1" to "Standard group" (6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy) and "Adjusted group" (6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy). Eligible patients enrolled in this study need to receive 6 cycles of docetaxel or paclitaxel (including liposome paclitaxel) and carboplatin on day 1, every 3 weeks. All patients need to receive at least 2 cycles of PEG-rhG-CSF administration. The primary outcome is the incidence of grade 3/4 neutropenia, and the duration of grade 3/4 neutropenia, the second outcomes are the incidence of FN, neutropenia-related hospitalization, incidence of reduction and delay of chemotherapy dose and safety of PEG-rhG-CSF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | Active comparator | Drug: PEG-rhG-CSF6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy. |
| Adjusted group | Experimental | Drug: PEG-rhG-CSF6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18 years or older
- Histopathology or cytology and immunomolecular biology diagnosed with ovarian cancer
- Grade 3/4 neutropenia appeared in previous chemotherapy
- accept at least 3 cycles of adjuvant chemotherapy
- expected survival time ≥ 8 months; KPS>70
Key exclusion criteria (15 listed)
- Uncontrolled infection, temperature≥38℃
- patients with bone marrow dysplasia and other hematopoietic dysfunction , or accepted stem cell or bone marrow transplant in 3 months before recruitment
- undergoing any other clinical trial in 4 weeks before recruitment
- undergoing radiotherapy in 4 weeks before recruitment
- Patients with other malignant tumors who have not been cured or have brain metastasis
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-CSF6mg PEG-rhG-CSF was administrated subcutaneously at different time after chemotherapy. | Drug | Adjusted group, Standard group |
Primary outcome
Incidence of grade 3/4 neutropenia
Time frame: At the end of cycle 2 (each cycle is 21 days)
Incidence of grade 3/4 neutropenia
The duration of grade 3/4 neutropenia
Time frame: At the end of cycle 2 (each cycle is 21 days)
The duration of grade 3/4 neutropenia
Results and safety
The study was stopped early (reason given: Sponsor Termination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Adjuvant Chemotherapy and Ovarian Neoplasms, run by Shandong University 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 11 inclusion and 15 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: stopped early, as of the sponsor's last update on 5 Jan 2024. 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?
The study was stopped early (reason given: Sponsor Termination). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 3/4 neutropenia (time frame: At the end of cycle 2 (each cycle is 21 days)). The study lists 2 primary outcomes in all. 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 5 Jan 2024.