Phase I/II trial of Biweekly induction DCE therapy

Phase 1

Recruiting

• Conditions: D000077195; Head and neck squamous cell carcinoma; Head and neck cancer, Squamous cell carcinoma, Induction chemotherapy

• Registration Number: JPRN-jRCTs051220137
• Lead Sponsor: Kiyota Naomi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 43

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities(Phase I), Objective Response of bwDCE(Phase II)

Secondary Outcome Measures

Name	Time	Method
Phase I<br>- Objective Response Rate of bwDCE ; ORR of bwDCE<br>- Overall response rate after treatment completion<br>- Adverse effect on CTCAE v5.0<br><br>Phase II<br>- Overall response rate after treatment completion<br>- Progression Free Survival ( PFS )<br>- Overall Survival ( OS )<br>- Treatment completion of chemoradiotherapy <br>- Adverse effect on CTCAE v5.0