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

NCT04542356 | Completed Phase 2

• 1 other identifier: CQGOG0104
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Incidence of Grade 3-4 neutropenia

  Incidence of Grade 3-4 neutropenia

  2 months

• Duration of grade 3-4 neutropenia

  Duration of grade 3-4 neutropenia

  2 months

Secondary Outcomes (5)

• Incidence of febrile neutropenia (FN)

  2 months

• the rate of postponement of the course of radiotherapy

  2 months

• reduction in chemotherapy dose

  2 months

• postponement of the course of chemotherapy

  2 months

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

  6 months

Study Arms (2)

experimental group

EXPERIMENTAL

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

Drug: PEG-rhG-CSF

control group

PLACEBO COMPARATOR

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

Drug: rhG-CSF

Interventions

PEG-rhG-CSF DRUG

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.

experimental group

rhG-CSF DRUG

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.

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (1)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Related Publications (6)

• 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.

  BACKGROUND

• 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.

  PMID: 25552400 BACKGROUND

• 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.

  PMID: 21133629 BACKGROUND

• 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．

  BACKGROUND

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

  PMID: 16305982 BACKGROUND

• 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.

  PMID: 34078317 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neutropenia

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Dongling Zou, M.D.

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Director

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 9, 2020
• Study Start: August 1, 2018
• Primary Completion: January 26, 2021
• Study Completion: May 26, 2021
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)