Single arm confirmatory trial of Intensity Modulated Proton Therapy (IMPT) combined with concurrent chemotherapy for locally advanced head and neck squamous cell carcinoma

JRCT ID: jRCTs032210291

Registered date:01/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Locally advanced squamous cell carcinoma of the head and neck (larynx, oropharynx, or hypopharynx)
• Date of first enrollment: 16/09/2021
• Target sample size: 75
• Study type: Interventional
• Intervention(s): Intensity modulated proton therapy with concurrent chemotherapy

Outcome(s)

• Primary Outcome: The incidence of grade 2 or worse late toxicities at 2-years after the completion of IMPT
• Secondary Outcome: The 2-year loco-regional control rate after the commencement of IMPT, the 2-year overall survival rate after the commencement of IMPT, the incidence of acute toxicities, any toxicities, and severe toxicities, Quality of life score before and 2 year after IMPT, the rate of best overall response

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Histologically proven squamous cell carcinoma of head and neck whose primary site is larynx, oropharynx, or hypopharynx
2) Clinical stage III/IV according to the UICC version 8 (including in patients with stage II oropharyngeal cancer with p16 positivity)
3) Aged 20 to 75 years old
4) ECOG PS of 0 or1
5) No obvious distant metastasis in radiological examinations including head and neck CT or MRI, chest and upper abdominal CT performed within 42 days before enrollment
6) No previous treatment history of chemotherapy or radiotherapy against any malignancy
7) To preserve adequate organ functions based on blood test within 14 days before enrollment
Hemoglobin; 9.5 g per dL or more
Neutrophil; 1500 per mm3 or more
Platelet; 100000 mm3 or more
AST and ALT; 100 IU per L or less
Total bilirubin; 1.5 mg per dL or less
Creatinine Clearance estimated value; 60 mL per min or more
8) To obtain consent with performing contraception (including consent from the partner)
9) To obtain written informed consent to attend the clinical trial.

Exclude criteria

1. Having active double cancer at enrollment including active synchronous cancer or metachronous cancer which occurred within 5 years before enrollment. Carcinoma in situ, mucosal cancers or skin cancers are excluded.
2. Having refractory active infection or inflammatory disease which necessitate systemic therapy.
3. HBs antigen positive.
4. Poor control diabetes mellitus which necessitate insulin therapy.
5. Difficulty in participating in the clinical trial due to serious mental illness.
6. Serious comorbities such as COPD, IPD, heart failure and so on.
7. Unstable angina occurring within 3 weeks before enrollment or with exacerbation of angina attack or acute myocardial infarction within 6 months before enrollment.
8. Attached with pacemaker of implantable cardioverter defibrillator.
9. Receiving systemic corticosteroid therapy including oral consumption or infusion.
10. Patients who refuse cessation of tobacco smoking and alcohol consumption
11. Pregnant women or women with potential pregnancy, or during lactating.
12. Any patient whom a physician in charge regarded as unsuitable for the enrollment of the trial.

* Caution
Treatment for patients with tumor that invades carotid arteries should be performed with caution; there is a risk for severe adverse events such as carotid hemorrhage, carotid artery exposure, and tumor hemorrhage.

Related Information

• Primary Sponsor: Okano Susumu
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development