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NCT04101760
Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer
Phase 3 trial testing Long-acting granulocyte colony stimulating factor in Chemotherapy-induced Neutropenia in 200 participants. Status unknown.
1 October 2020
Quick facts
| Lead sponsor | Lei Li |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 October 2019 |
| Primary completion | 1 October 2020 |
| Estimated completion | 1 October 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- Long-acting granulocyte colony stimulating factor — full drug profile →
- Short-acting granulocyte colony stimulating factor — full drug profile →
Conditions studied
- Chemotherapy-induced Neutropenia — all drugs for Chemotherapy-induced Neutropenia →
- Febrile Neutropenia, Drug-Induced — all drugs for Febrile Neutropenia, Drug-Induced →
- Epithelial Ovarian Cancer — all drugs for Epithelial Ovarian Cancer →
- Colony Stimulating Factors Adverse Reaction — all drugs for Colony Stimulating Factors Adverse Reaction →
Sponsor
Lei Li — full company profile →
Who can join
18 and older, any sex, with Chemotherapy-induced Neutropenia or Febrile Neutropenia, Drug-Induced. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to analyze the effects of long-acting versus short-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer patients. Patients receive platinum-based chemotherapy of 3 to 4 weeks. Patients are randomized into study group and control group. In study group, patients accept long-acting G-CSF 48 hours from the chemotherapy. While the control group accept regular or prophylactic treatment of short-acting G-CSF according to National Comprehensive Cancer Network guidelines. The primary end is the incidence of FN in every course of chemotherapy. The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF, quality of life, and survival outcomes (progression-free survival and overall survival).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04101760
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06537726 — Breath Analysis for the Detection of Invasive Fungal Infections · recruiting
- NCT07096479 — Telpegfilgrastim Injection to Reduce the Risk of Neutropenia in Patients With Solid Tumor · recruiting
- NCT05245487 — Danish Elder Lymphoma Patient Hematopoietic Investigation · recruiting
Other Lei Li trials
Trials by the same sponsor.
- NCT06558019 — Exosome-based OCS Scores for Predicting Ovarian Cancer Recurrence · not yet recruiting
- NCT06557954 — Cervical Cytology DNA Methylation for Cervical Cancer Screening · not yet recruiting
- NCT05801263 — ctDNA Methylation for Epithelial Ovarian Cancer · unknown
- NCT05801276 — ctDNA Methylation for Detecting Ovarian Cancer · unknown
- NCT06490380 — HRD Status Reference Standard Based on WGS · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04101760 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lei Li
- Last refreshed: 8 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04101760.
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