Concomitant Chemoradiotherapy (CCRT) With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer

NCT ID: NCT01126008

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-16
• Study Completion Date: 2016-04-15

Brief Summary

This phase II trial is evaluating the efficacy of concurrent chemoradiation therapy with weekly docetaxel and cisplatin combination regimen.

Detailed Description

Many studies have shown the superiority of concurrent chemoradiotherapy over radiotherapy only in locally advanced head and neck cancer. Concurrent chemoradiotherapy with high dose cisplatin has been universally used regimen. In a large-scaled phase II trial, however, conducted by the European Organization for the Research and Treatment of Cancer (EORTC), docetaxel (100mg/m2) plus cisplatin (75mg/ m2) every three weeks regimen produced improved survival, nonetheless there was significant limitation to deliver full doses of treatment due to significant hematologic and non-hematologic toxicities. Previously, we showed the safety of the combination regimen of weekly docetaxel and cisplatin in concurrent chemoradiation treatment in a phase I study. We determined the MTD of docetaxel to be 20mg/m2 weekly when concurrently administered with conventional fractionation RT and weekly 20mg/m2 of cisplatin.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

weekly docetaxel and cisplatin

Group Type: EXPERIMENTAL

CCRT with weekly docetaxel & cisplatin

Intervention Type: DRUG

radiotherapy: 70Gy/35 fraction for 7 weeks chemotherapy: docetaxel 20mg/m2 and cisplatin 20mg/m2 weekly for 6 weeks

Interventions

CCRT with weekly docetaxel & cisplatin

radiotherapy: 70Gy/35 fraction for 7 weeks chemotherapy: docetaxel 20mg/m2 and cisplatin 20mg/m2 weekly for 6 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) of one of following sites : oral cavity, oropharynx, larynx, or hypopharynx

2. Unresectable Stage III - ⅣB disease

3. previously untreated for head & Neck cancer with chemotherapy or radiotherapy

4. 18 and over

5. Performance status ECOG 0-1

6. Absolute neutrophil count ≥ 1,500/mm3

7. Platelet count ≥ 75,000/mm3

8. Hemoglobin > 9.0 g/dL

9. Bilirubin ≤ 1.5 times upper limit of normal (ULN)

10. AST or ALT, and alkaline phosphatase meeting 1 of the following parameters:Alkaline phosphatase ≤ 1.5 times ULN AND AST or ALT ≤ 5 times ULN Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN

11. serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min

Exclusion Criteria

1. Distant metastatic disease (M1)

2. Prior chemotherapy or RT for Head and neck cancer

3. Synchronous or concurrent head and neck primary tumors

4. Lip, nasopharynx, nasal cavity, salivary gland, or sinuses

5. No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or papillary thyroid cancer

6. Other concurrent illness that would preclude study participation

7. Other concurrent physical condition (e.g., infectious disease) that would preclude study participation

8. pregnant or nursing

9. Fertile patients must use effective contraception during and for 3 months after study participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Keunchil Park

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2009-10-007

Identifier Type: -

Identifier Source: org_study_id