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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542356
• Other study ID #: CQGOG0104
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2018
• Est. completion date: May 26, 2021

Study information

• Verified date: September 2023
• Source: Chongqing University Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 26, 2021
• Est. primary completion date: January 26, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Neutropenia
• Uterine Cervical Neoplasms

Intervention

Drug:
• PEG-rhG-CSF
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-CSF
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.

Locations

Country	Name	City	State
China	Chongqing Cancer Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing University Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Grade 3-4 neutropenia	Incidence of Grade 3-4 neutropenia	2 months
Primary	Duration of grade 3-4 neutropenia	Duration of grade 3-4 neutropenia	2 months
Secondary	Incidence of febrile neutropenia (FN)	Incidence of febrile neutropenia (FN)	2 months
Secondary	the rate of postponement of the course of radiotherapy	the rate of postponement of the course of radiotherapy	2 months
Secondary	reduction in chemotherapy dose	reduction in chemotherapy dose	2 months
Secondary	postponement of the course of chemotherapy	postponement of the course of chemotherapy	2 months
Secondary	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	6 months