A Phase2 study of the safety and efficacy of pegfilgrastism for the prevention of febrile neutropenia in patients receiving TPF therapy for squamous cell carcinoma of the head and neck.

Phase 2

Recruiting

• Conditions: squamous cell carcinoma of the head and neck; head and neck cancer

• Registration Number: JPRN-jRCTs031220695
• Lead Sponsor: Saito Yuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

(1) Patients using one of the following TPF therapies for advanced squamous cell carcinoma of the head and neck
- Those who use TPF therapy as induction chemotherapy (ICT)
- Those who use chemoradiotherapy combined with TPF (CRT) as radical therapy
(2) Those with a primary lesion in the head and neck and clinical stage III, IVA, and IVB
(3) Those whose Performance status (PS) is 0 or 1
(4) Those who are between 18 and 80 years of age at the time of obtaining consent
(5) Male or female
(6) Those whose most recent laboratory values within 14 days prior to registration meet all the following criteria
1. Neutrophil count >=1,500/mm3
2. Hemoglobin >=9.0 g/dL
3. Platelet count >= 10 x 10,000/mm3
4. Total bilirubin <= 2.0 mg/dL
5. AST<=100 U/L
6. ALT<=100 U/L
7. Estimated creatinine clearance (Cockcroft-Gault formula) >=60 mL/min or eGFR (estimated glomerular filtration rate) >=60.0 mL/min
(7) Those who have received a full explanation of the study and have given written consent of their own free will based on a full understanding of the study

Exclusion Criteria

(1) Those with a fever of 38.0 or higher at the time of registration
(2) Those with a white blood cell count of 2000/microL or less at the time of registration
(3) Those with serious hepatic, renal, or cardiovascular disorders (determined with reference to Grade 3 of the JCOG version of the CTCAE version 5.0)
(4) Those with active overlapping cancers (including leukemia)
(5) Those with complications or history of severe myelosuppression and complications or history of infection associated with myelosuppression
(6) Those with history of serious drug allergy, including anaphylactic shock, or history of serious adverse drug reactions
(7) Those with hypersensitivity to the following ingredients
- Components of pegfilgrastim or other granulocyte colony-forming stimulating factor preparations
- Preparations containing polysorbate 80
- Agents containing platinum
- Fuorouracil
(8) Those who are on tegafur/gimeracil/oteracil potassium combination drug or within 7 days after discontinuing administration of these medication
(9) Those who have psychiatric disorders or psychiatric symptoms that interfere with their daily lives and make it difficult for them to participate in the study
(10) Those who are pregnant, possibly pregnant, or are breastfeeding
(11) In addition, those who are judged inappropriate for participation in this study by the principal investigator or co-investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified