A Phase II study 2 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.

A Phase II study 2 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. - PROCEED 2

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031250779

Enrollment

Registered

2026-03-06

Start date

2026-04-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Head and Neck Squamous Cell Carcinoma head and neck cancer

Interventions

TPF therapy is administered for 21 days (1 course). Pegfilgrastim is administered on the 3rd day (Day 3) of the TPF therapy start date (Day 1).

Pegfilgrastim

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with advanced head and neck squamous cell carcinoma receiving TPF therapy as induction chemotherapy (ICT). (2) Patients with a primary tumor in the head and neck and Stage III, IVA, or IVB disease. (3) Performance status (PS) of 0 or 1. (4) Age >= 18 and = 1,500/mm3 (ii) Hemoglobin >= 9.0 g/dL (iii) Platelet count >= 100,000/mm3 (iv) Total bilirubin = 60 mL/min or eGFR (estimated Glomerular Filtration Rate) >= 60.0 mL/min. (7) Patients who have voluntarily provided written informed consent after receiving a full explanation regarding participation in this study and fully understanding its contents.

Exclusion criteria

Exclusion criteria: (1) Patients with a fever of >= 38.0 degrees Celsius at the time of registration. (2) Patients with a white blood cell count of <= 2000/microL in the latest laboratory values within 14 days prior to registration. (3) Patients with severe hepatic, renal, or cardiovascular disease (determined based on Grade 3 of JCOG CTCAE version 5.0). (4) Patients with active double cancer (including leukemia). (5) Patients with complications or history of severe myelosuppression or infection, and complications or history of infection associated with myelosuppression. (6) Patients with a history of severe drug allergies such as anaphylactic shock or a history of severe adverse reactions. (7) Patients with hypersensitivity to the following components: - Components of Pegfilgrastim or other granulocyte colony-stimulating factor (G-CSF) preparations - Polysorbate 80-containing preparations - Platinum-containing drugs - Fluorouracil (8) Patients receiving tegafur/gimeracil/oteracil potassium combination drugs or within 7 days after discontinuation. (9) Patients with concurrent mental disorders or psychiatric symptoms interfering with daily life, judged to make participation in the study difficult. (10) Patients who are pregnant, possibly pregnant, or breastfeeding. (11) Any other patients judged by the Principal Investigator or Co-Investigator to be ineligible for participation in this study.

Design outcomes

Primary

Measure	Time frame
Incidence rate of febrile neutropenia by the end of 1 course of TPF therapy.	—

Secondary

Measure	Time frame
(1) Incidence rate of fever by the end of 1 course of TPF therapy. (2) Neutrophil count by the end of 1 course of TPF therapy. (3) Tumor control rate at the completion of 1 course of TPF therapy.	—

Contacts

Public ContactYuki Saito

The University of Tokyo Hospital

saitou.tky@gmail.com+81-338155411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026