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CompletedNCT01126008Updated Mar 22, 2021

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

A Phase 2 interventional study of CCRT with weekly docetaxel & cisplatin in Head and Neck Cancer, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-22.

Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2009, registered May 2010).
Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Head and Neck Cancer

Keywords

  • locally advanced Squamous cell carcinoma
03

In context

Head and Neck Neoplasms

2,347 studies on the registry are indexed under Head and Neck Neoplasms; 553 are open to participants now.

This study's enrollment of 44 is close to the median of 47 across 1,753 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    weekly docetaxel and cisplatin

    Drug: CCRT with weekly docetaxel & cisplatin

Interventions

  • DrugCCRT with weekly docetaxel & cisplatin

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

06

What researchers measure

Primary outcomes

  1. Complete response rate

    Time frame: 3-4 weeks after completion of CCRT

Secondary outcomes

  1. quality of life

    Time frame: Pretreatment & 3-4 weeks after completion of treatment

  2. overall survival rate

    Time frame: 2 year

  3. disease free survival rate

    Time frame: 2 year

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01126008
Lead sponsor
Samsung Medical Center
Responsible party
Keunchil Park (Principal investigator, Samsung Medical Center) — Principal investigator
First posted
May 19, 2010
Start date
Nov 16, 2009
Primary completion
Apr 15, 2016
Completion
Apr 15, 2016
Last update
Mar 22, 2021
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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