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Phase II Safety and Toxicity Study of Cisplatin With or Without Cetuximab and Concomitant Radiotherapy for Locoregionally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Neoplasms, AJCC Stage III/IV

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Trial Information

Phase II Safety and Toxicity Study of Cisplatin With or Without Cetuximab and Concomitant Radiotherapy for Locoregionally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)


Conventional radiotherapy (65-70 Gy, 1.8 Gy per day) concurrently with weekly cisplatin
(40mg/m2) (group A, n=25) or with weekly cisplatin (40mg/m2) and weekly cetuximab 250mg/m2,
after initial dose of 400mg/m2) (group B, n=25) is applied (in a 1:1 randomization ratio).
Groups will be matched age, sex, PS, and disease site.


Inclusion Criteria:



- histologically confirmed HNSCC of oral cavity, larynx, oropharynx or

- hypopharynx; age of 18 years or more

- adequate liver (SGOT, SGPT, ALP ≤ 3x normal)

- kidneys (creatinine clearance ≥ 60ml/min

- heart (no arrythmias, no heart failure) and

- bone marrow (WBC ≥ 4,000/μL, granulocytes ≥ 1,500/μL, Hb ≥ 10g/dL, platelets ≥
100,000/μL) function

- ECOG performance status 0 or 1 and

- stage III or IVa to b with measurable lesions

- written informed consent

Exclusion Criteria:

- prior radiotherapy

- chemotherapy

- concurrent active malignancies

- pregnancy

- breast-feeding

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine safety and toxicity of combination

Outcome Description:

Toxicity is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 1 system.

Outcome Time Frame:

Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months

Safety Issue:

Yes

Principal Investigator

Charalambos Andreadis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Theagenio Cancer Hospital

Authority:

Greece: Ethics Committee

Study ID:

EEEK2008RCT2

NCT ID:

NCT01301248

Start Date:

March 2008

Completion Date:

June 2011

Related Keywords:

  • Head and Neck Neoplasms
  • AJCC Stage III/IV
  • locally advanced,
  • unresectable,
  • head and neck squamous cell carcinoma,
  • stage III/IV
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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