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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CCRT with weekly docetaxel & cisplatin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring locally advanced Squamous cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

weekly docetaxel and cisplatin

Arm Description

Outcomes

Primary Outcome Measures

Complete response rate

Secondary Outcome Measures

quality of life
overall survival rate
disease free survival rate

Full Information

First Posted
May 17, 2010
Last Updated
March 18, 2021
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01126008
Brief Title
Concomitant Chemoradiotherapy (CCRT) With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer
Official Title
A Phase II Trial of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 16, 2009 (Actual)
Primary Completion Date
April 15, 2016 (Actual)
Study Completion Date
April 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
locally advanced Squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
weekly docetaxel and cisplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CCRT with weekly docetaxel & cisplatin
Intervention Description
radiotherapy: 70Gy/35 fraction for 7 weeks chemotherapy: docetaxel 20mg/m2 and cisplatin 20mg/m2 weekly for 6 weeks
Primary Outcome Measure Information:
Title
Complete response rate
Time Frame
3-4 weeks after completion of CCRT
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
Pretreatment & 3-4 weeks after completion of treatment
Title
overall survival rate
Time Frame
2 year
Title
disease free survival rate
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) of one of following sites : oral cavity, oropharynx, larynx, or hypopharynx Unresectable Stage III - ⅣB disease previously untreated for head & Neck cancer with chemotherapy or radiotherapy 18 and over Performance status ECOG 0-1 Absolute neutrophil count ≥ 1,500/mm3 Platelet count ≥ 75,000/mm3 Hemoglobin > 9.0 g/dL Bilirubin ≤ 1.5 times upper limit of normal (ULN) 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 serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min Exclusion Criteria: Distant metastatic disease (M1) Prior chemotherapy or RT for Head and neck cancer Synchronous or concurrent head and neck primary tumors Lip, nasopharynx, nasal cavity, salivary gland, or sinuses No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or papillary thyroid cancer Other concurrent illness that would preclude study participation Other concurrent physical condition (e.g., infectious disease) that would preclude study participation pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study participation
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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

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