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

Primary Purpose

Cervical Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

PEG-rhG-CSF

rhG-CSF

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring Cervical Cancer, concurrent chemoradiotherapy, neutropenia, PEG-rhG-CSF

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

1）18-70 years old; 2）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.

3）The expected survival time was more than 8 months; the Eastern Cooperative Oncology Group (ECOG) performance status score≤1; 4）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); 5）No obvious abnormality in the ECG examination, and no obvious cardiac dysfunction; 6）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; 7）The subjects voluntarily participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

1）Those who refuse to accept PEG-rh-G-CSF; 2) Currently conducting clinical trials of other drugs; 3) Uncontrolled infection before treatment, body temperature ≥ 38℃; 4）Chronic diseases of the heart, kidney, liver or other important organs; 5) Patients with severe uncontrolled diabetes; (6) Pregnant or lactating female patients; 7）Persons with allergic diseases or allergic constitution, or allergic to this product or other biological products derived from genetically engineered E. coli; 8) Suspected or confirmed drug, substance or alcohol abuse; 9) Severe mental or neurological disorders that affect informed consent and/or adverse reaction presentation or observation; 10）HIV-positive people; 11）Patients requiring radiation therapy for the retroperitoneal or inguinal region.

Sites / Locations

Chongqing Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

experimental group

control group

Arm Description

patients used 6 mg PEG-rhG-CSF prophylactically after chemotherapy

patients did not use PEG-rhG-CSF for prevention and were given 5 ug/kg rhG-CSF when ANC<1✕109/L

Outcomes

Primary Outcome Measures

Incidence of Grade 3-4 neutropenia

Duration of grade 3-4 neutropenia

Secondary Outcome Measures

Incidence of febrile neutropenia (FN)

the rate of postponement of the course of radiotherapy

reduction in chemotherapy dose

postponement of the course of chemotherapy

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

Full Information

NCT ID

NCT04542356

First Posted

September 2, 2020

Last Updated

September 4, 2023

Sponsor

Chongqing University Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04542356

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

January 26, 2021 (Actual)

Study Completion Date

May 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chongqing University Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

Cervical Cancer, concurrent chemoradiotherapy, neutropenia, PEG-rhG-CSF

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

experimental group

Arm Type

Experimental

Arm Description

patients used 6 mg PEG-rhG-CSF prophylactically after chemotherapy

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

patients did not use PEG-rhG-CSF for prevention and were given 5 ug/kg rhG-CSF when ANC<1✕109/L

Intervention Type

Drug

Intervention Name(s)

PEG-rhG-CSF

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

rhG-CSF

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of Grade 3-4 neutropenia

Description

Incidence of Grade 3-4 neutropenia

Time Frame

2 months

Title

Duration of grade 3-4 neutropenia

Description

Duration of grade 3-4 neutropenia

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Incidence of febrile neutropenia (FN)

Description

Incidence of febrile neutropenia (FN)

Time Frame

2 months

Title

the rate of postponement of the course of radiotherapy

Description

the rate of postponement of the course of radiotherapy

Time Frame

2 months

Title

reduction in chemotherapy dose

Description

reduction in chemotherapy dose

Time Frame

2 months

Title

postponement of the course of chemotherapy

Description

postponement of the course of chemotherapy

Time Frame

2 months

Title

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

Description

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

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dongling Zou, M.D.

Organizational Affiliation

Chongqing University Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chongqing Cancer Hospital

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400030

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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Results Reference

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PubMed Identifier

25552400

Citation

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.

Results Reference

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PubMed Identifier

21133629

Citation

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.

Results Reference

background

Citation

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．

Results Reference

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PubMed Identifier

16305982

Citation

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

Results Reference

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PubMed Identifier

34078317

Citation

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.

Results Reference

derived

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

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