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Cervical CancerPhase 2NCT04542356

Study on the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia During Concurrent Chemoradiotherapy of Cervical Cancer

A Phase 2 study testing PEG-rhG-CSF and rhG-CSF in people with Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled prospective study aims to explore the efficacy and safety of using (PEGylated Recombinant Human Granulocyte Stimulating Factor) PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of paclitaxel and cisplatin (TP) regimen for cervical cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
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?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
1 Aug 2018to 26 May 2021
Phase
Phase 2
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-70 years old;
  • Patients with cervical cancer who have not undergone surgery for initial treatment, the international union of gynecology and obstetrics (FIGO) stage IIb-IIIb; Squamous cell carcinoma diagnosed by histopathology.
  • The expected survival time was more than 8 months; the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;
  • Bone marrow hematopoietic function is normal before treatment (ANC≥1.8×109/L, PLT≥100×109/L, Hb≥90g/L, WBC≥4.0×109/L);
  • No obvious abnormality in the ECG examination, and no obvious cardiac dysfunction;
  • All patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment, and women of childbearing age must have a negative urine pregnancy test prior to treatment administration;
  • The subjects voluntarily participate in this clinical trial and sign an informed consent form.

Who cannot join

  • Those who refuse to accept PEG-rh-G-CSF;
  • Currently conducting clinical trials of other drugs;
  • Uncontrolled infection before treatment, body temperature ≥ 38℃;
  • Chronic diseases of the heart, kidney, liver or other important organs;
  • Patients with severe uncontrolled diabetes;
  • Pregnant or lactating female patients;
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  • Persons with allergic diseases or allergic constitution, or allergic to this product or other biological products derived from genetically engineered E. coli;
  • Suspected or confirmed drug, substance or alcohol abuse;
  • Severe mental or neurological disorders that affect informed consent and/or adverse reaction presentation or observation;
  • HIV-positive people;
  • Patients requiring radiation therapy for the retroperitoneal or inguinal region.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

Other trials in China

About this study

Official title: Efficacy and Safety of PEGylated Recombinant Human Granulocyte Stimulating Factor in the Prevention of Neutropenia During Concurrent Chemoradiotherapy for Cervical Cancer

This randomized controlled prospective study aims to explore the efficacy and safety of using (PEGylated Recombinant Human Granulocyte Stimulating Factor) PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of paclitaxel and cisplatin (TP) regimen for cervical cancer. To find out the best time to use PEG-rhG CSF, and to explore investigate the effect of PEG-rhG-CSF on long-term bone marrow function in the process of concurrent chemoradiotherapy, and finally to explore the clinical feasibility of using PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of TP regimen for cervical cancer.

Read the detailed description

Study design: In this prospective, single-center, randomized controlled study, patients with locally advanced cervical cancer are randomly divided into two groups. Patients in the experimental group will receive PEG-rhG-CSF 6mg prevention during concurrent chemoradiotherapy, whereas the control group do not use PEG-rhG-CSF for prevention. When the patient's ANC is less than 1✕109/L, 5μg/kg rhG-CSF will be given for treatment until the ANC returned to 2✕109/L.

Case selection: patients with IIb-IIIb cervical cancer, squamous cell carcinoma confirmed by histopathology, and three-week regimen of paclitaxel and carboplatin with Concurrent Radiotherapy.

Primary end point: incidence and duration of grade 3/4 neutropenia in patients. Secondary endpoints: 1) Incidence of febrile neutropenia (FN); 2) the rate of postponement of the course of radiotherapy, reduction in chemotherapy dose and postponement of the course of chemotherapy; 3) Changes of bone marrow function in patients 3 months and 6 months after radiotherapy.

Safety assessment: laboratory safety testing, including platelet count and hemoglobin. Evaluation of adverse events: infection, neutropenic fever, bone pain, etc.

Conditions
Cervical Cancer
Being tested
PEG-rhG-CSF, rhG-CSF
Keywords
Cervical Cancer, concurrent chemoradiotherapy, neutropenia, PEG-rhG-CSF
Medical subject headings
Uterine Cervical Neoplasms, Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEG-rhG-CSFDrug

    During the concurrent chemoradiotherapy, a single subcutaneous injection of 6 mg PEG-rhG-CSF was given to the patient 2 hours after radiotherapy on the first day after the end of chemotherapy. Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during radiotherapy, rhG-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.

  • rhG-CSFDrug

    Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during radiotherapy, rhG-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.

Study groups in NCT04542356
Study groupRoleWhat they receive
experimental groupExperimentalpatients used 6 mg PEG-rhG-CSF prophylactically after chemotherapy
Receives: Drug: PEG-rhG-CSF
control groupPlacebo comparatorpatients did not use PEG-rhG-CSF for prevention and were given 5 ug/kg rhG-CSF when ANC<1✕109/L
Receives: Drug: rhG-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Grade 3-4 neutropenia

    Incidence of Grade 3-4 neutropenia

    Measured: 2 months

  2. Duration of grade 3-4 neutropenia

    Duration of grade 3-4 neutropenia

    Measured: 2 months

Secondary outcomes (5)

  1. Incidence of febrile neutropenia (FN)

    Incidence of febrile neutropenia (FN)

    Measured: 2 months

  2. the rate of postponement of the course of radiotherapy

    the rate of postponement of the course of radiotherapy

    Measured: 2 months

  3. reduction in chemotherapy dose

    reduction in chemotherapy dose

    Measured: 2 months

  4. postponement of the course of chemotherapy

    postponement of the course of chemotherapy

    Measured: 2 months

  5. Changes of bone marrow function in patients 3 months and 6 months after radiotherapy

    Changes of bone marrow function in patients 3 months and 6 months after radiotherapy

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study start1 Aug 2018
  3. Primary completion26 Jan 2021
  4. Study completion26 May 2021

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04542356
Sponsor's protocol ID
CQGOG0104
Status last verified
Sep 2023
First submitted
2 Sep 2020
Last updated
6 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cartmell MP, Ziegler SW, Neill DS. On the performance prediction and scale modelling of a motorised momentum exchange propulsion tether[J]. Gynecol Oncol, 2003, 654 (1): 571-579.

  • Liu Y, Zhang X, An S, Wu Y, Hu G, Wu Y. Pharmacokinetics of neamine in rats and anti-cervical cancer activity in vitro and in vivo. Cancer Chemother Pharmacol. 2015 Mar;75(3):465-74. doi: 10.1007/s00280-014-2658-7. Epub 2015 Jan 1.

    PubMed 25552400

  • Saha A, Chaudhury AN, Bhowmik P, Chatterjee R. Awareness of cervical cancer among female students of premier colleges in Kolkata, India. Asian Pac J Cancer Prev. 2010;11(4):1085-90.

    PubMed 21133629

  • Moore TD，Patel T，et al．A sir pesfligrastim dose per cycle supports dose-dense(q14d)CHOP-R in patients with non Hodgkin's lymphoma[J]．Proc Am Soc Hematol，2003，102(11): 2365．

  • Lokich J. Same-day pegfilgrastim and chemotherapy. Cancer Invest. 2005;23(7):573-6. doi: 10.1080/07357900500276899.

    PubMed 16305982

  • Zou D, Guo M, Zhou Q. A clinical study of pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) in preventing neutropenia during concurrent chemoradiotherapy of cervical cancer. BMC Cancer. 2021 Jun 2;21(1):661. doi: 10.1186/s12885-021-08364-9.

    PubMed 34078317

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PEG-rhG-CSF and rhG-CSF in people with Cervical Cancer, run by Chongqing University Cancer Hospital 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 11 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: finished, as of the sponsor's last update on 6 Sep 2023. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: 2 months). 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?

On the ClinicalTrials.gov record for NCT04542356, which also lists 6 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 6 Sep 2023.

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