JCOG1912: Novel approach of prophylactic radiation to reduce toxicities comparing 2-step-40 with SIB-56 IMRT techniques for locally advanced squamous cell carcinoma of the head and neck, an intergroup phase III trial.

JRCT ID: jRCTs031210100

Registered date:18/05/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: locally advanced squamous cell carcinoma of the head and neck
• Date of first enrollment: 18/06/2021
• Target sample size: 400
• Study type: Interventional

Intervention(s)

A: Preventive irradiation dose standard group (56 Gy)
CDDP (100 mg/m2, every 3 weeks, 3 times) in combination with radiation therapy.
Radiation therapy (IMRT) : SIB56 method (tumor area 70 Gy/35 Fr/7 weeks, preventive irradiation area 56 Gy/35 Fr/7 weeks).
B: Preventive irradiation dose reduction group (40 Gy)
CDDP (100 mg/m2, every 3 weeks, 3 times) in combination with radiation therapy.
Radiation therapy (IMRT) : 2-step 40 method (tumor area 70 Gy/35 Fr/7 weeks, preventive irradiation area 40 Gy/20 Fr/4 weeks).

Outcome(s)

Primary Outcome

time to treatment failure 1
(starting from the registration date to the earliest of the following, the date of progression, the date of judgement of tumor remnants after the completion of protocol treatment, or the date of death due to any cause.)

• Secondary Outcome: overall survival, complete response proportion, progression-free survival, loco-regional progression-free survival, time to treatment failure 2, proportion of acute adverse events, proportion of late adverse events, QOL survey (EORTC QLQ-C30, QLQ-HN43), swallowing function evaluation (swallowing endoscopy, functional outcome swallowing scale).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Primary lesion exists in the oropharynx, hypopharynx, or larynx.
(2) Histologically proven squamous cell carcinoma from primary leision biopsy. In case of oropharyngeal cancer, p16 is negative by immunohistochemical staining (IHC).
(3) Comprehensively diagnosed as stage III-IVB (UICC-TNM 8th edition) by the following (except for N3a).
(i) Head and neck contrast-enhanced MRI
(ii) Thoracoabdominal CT
(4) Aged 20 years and older.
(5) ECOG Performance status 0 or 1.
(6) Presence of measurable lesions is not mandatory.
(7) No history of chemotherapy for any cancer, and radiation therapy for the brain and head and neck. No history of surgery for head and neck cancer.
(8) Following (i) or (ii) is satisfied.
(i) Judged that technically and functionally radical surgical resection is impossible by consulting with head and neck surgeon or otolaryngologist.
(ii) Patients do not have a preference to receive a surgical resection, even though the surgeon judged surgical resection is possible.
(9) Major organ function is preserved.
(i) Neutrophil count >= 1,500 /mm3
(ii) Hemoglobin >= 9.0 mg/dl
(iii) Platelet count >= 100,000 /mm3
(iv) T-bil<=2.0 mg/dL
(v) AST =< 100 U/L
(vi) ALT =< 100 U/L
(vii) Ccr>=60 mL/min
(10) Written informed consent.

Exclude criteria

(1) Simultaneous or metachronous (within 3 years) double cancers , with the exception of intramucosal tumor curable with local therapy.
(2) Active infection requiring systemic therapy.
(3) Fever over 38 degrees Celsius
(4) Female during pregnancy, within 28 days of postparturition, or during lactation. Male who wants partner's pregnancy.
(5) Psychological disorder difficult to participate in this clinical study.
(6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
(7) Diabetes mellitus uncontrollable with continuous use of insuline or hypoglycemic agents.
(8) Uncontrolled arterial hypertension.
(9) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
(10) Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
(11) Positive for HBs antigen.
(12) Positive for HIV antibody.
(13) Judged that smoking cessation and abstinence are impossible during protocol treatment.

Related Information

• Primary Sponsor: Kodaira Takeshi
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development