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

March 18, 2021 updated by: Keunchil Park, Samsung Medical Center

A Phase II Trial of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: weekly docetaxel and cisplatin
Drug: CCRT with weekly docetaxel & cisplatin
radiotherapy: 70Gy/35 fraction for 7 weeks chemotherapy: docetaxel 20mg/m2 and cisplatin 20mg/m2 weekly for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete response rate
Time Frame: 3-4 weeks after completion of CCRT
3-4 weeks after completion of CCRT

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life
Time Frame: Pretreatment & 3-4 weeks after completion of treatment
Pretreatment & 3-4 weeks after completion of treatment
overall survival rate
Time Frame: 2 year
2 year
disease free survival rate
Time Frame: 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2009

Primary Completion (Actual)

April 15, 2016

Study Completion (Actual)

April 15, 2016

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (Estimate)

May 19, 2010

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-10-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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