Phase I/II trial of Biweekly induction DCE therapy

JRCT ID: jRCTs051220137

Registered date:20/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Head and neck squamous cell carcinoma
• Date of first enrollment: 20/12/2022
• Target sample size: 43
• Study type: Interventional
• Intervention(s): Combination therapy of docetaxel, carboplatin and cetuximab

Outcome(s)

• Primary Outcome: Dose-limiting toxicities(Phase I), Objective Response of bwDCE(Phase II)

Secondary Outcome

Phase I
- Objective Response Rate of bwDCE ; ORR of bwDCE
- Overall response rate after treatment completion
- Adverse effect on CTCAE v5.0

Phase II
- Overall response rate after treatment completion
- Progression Free Survival ( PFS )
- Overall Survival ( OS )
- Treatment completion of chemoradiotherapy
- Adverse effect on CTCAE v5.0

Key inclusion & exclusion criteria

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

Include criteria

Histologically proven squamous cell carcinoma of head and neck
- Primay site of Oral, Oropharynx, Hypopharynx, Larynx.
Locally advanced head and neck cancer patient.
Age 20 years or older, signed informed consent obtained before any study specific procedures.
No previous chemotherapy, No previous radiation therapy for brain, head and neck region.
No previous surgery for head and neck cancer
ECOG-PS of 0 to 1.
Adequate bone marrow, liver function assessed within 14 days before starting study treatment.
- Neutrophils counts >= 1500/mm3
- Hb >= 9.0 g/dl
- Platelet counts>= 100,000/mm3
- Total bilirubin: =< 1.5 mg/dl (In case of patient with constitutional jaundice, total bilirubin is allowed =< 3.0 mg/dl)
- AST/ALT =< 100/100 IU/l
- Cr<1.5mg/dl

Exclude criteria

Active concomitant malignancy except carcinoma in situ or intramucosal tumor within 5 years before study entry.
Metastasis
Active uncontrolled infection disease needed treatment.
HIV infected patient.
Lung fibrosis, acute lung damage or intestinal lung disease.
Peripheral neuropathy CTCAE Grade 2.
Hemodialysis patients.
Severe allergy/infusion reaction (Grade 3/4) or side effect for docetaxel, carboplatin or cetuximab.
Allergy for beef or Ticks

Related Information

• Primary Sponsor: Kiyota Naomi