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A Phase ll Trial of Induction Docetaxel and S-1 Followed by Concomitant Radiotherapy With Low-dose Daily Cisplatin in Locally Advanced Head and Neck Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

A Phase ll Trial of Induction Docetaxel and S-1 Followed by Concomitant Radiotherapy With Low-dose Daily Cisplatin in Locally Advanced Head and Neck Cancer


OBJECTIVES:

Primary

- To assess the response rate in patients with stage III or IV head and neck cancer
treated with induction therapy comprising docetaxel and S-1 followed by radiotherapy
and low-dose cisplatin.

Secondary

- To assess the effect of this regimen on survival and locoregional and systemic control
rates in these patients.

OUTLINE:

- Induction chemotherapy: Patients receive oral S-1 twice daily on days 1-14 and
docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 2 courses in the
absence of disease progression or unacceptable toxicity.

- Chemoradiotherapy: Patients receive low-dose cisplatin IV once daily and undergo
radiotherapy 5 days a week for 7 weeks in the absence of disease progression or
unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Pathologically confirmed head and neck cancer arising from the oral cavity,
oropharynx, hypopharynx, or nasopharynx, including any of the following subtypes:

- Squamous cell carcinoma

- Poorly differentiated carcinoma

- Lymphoepithelioma

- Locally advanced disease (stage III or IV [M0] disease)

- At least 1 unidimensionally measurable index lesion

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9 g/dL

- Bilirubin ≤ 1.5 times the upper limit of normal (ULN)

- Alkaline phosphatase ≤ 3.0 times ULN

- AST and ALT ≤ 3.0 times ULN

- Creatinine ≤ 1.5 times ULN

- No concurrent serious systemic disorder that, in the opinion of investigator, would
compromise the patient's ability to complete the study

- No serious cardiac condition, including any of the following:

- Myocardial infarction within the past 6 months

- Angina

- NYHA class III-IV heart disease

- No active infection requiring IV antibiotics, including active tuberculosis or HIV

- No other malignancy within the past 5 years except basal cell carcinoma of the skin
or pre-invasive carcinoma of the cervix

- Able to comply with protocol or study procedures

PRIOR CONCURRENT THERAPY:

- No prior radiotherapy or chemotherapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (complete or partial response) as assessed by RECIST criteria

Safety Issue:

No

Principal Investigator

Joo-Hang Kim, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Yonsei University

Authority:

Unspecified

Study ID:

CDR0000582621

NCT ID:

NCT00625937

Start Date:

November 2006

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage III verrucous carcinoma of the oral cavity
  • stage IV verrucous carcinoma of the oral cavity
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage III lymphoepithelioma of the nasopharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage III lymphoepithelioma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • tongue cancer
  • Head and Neck Neoplasms

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