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A Phase II Study of Neoadjuvant Bio-chemotherapy With Cetuximab, Paclitaxel, and Cisplatin (CPC) Followed by Cetuximab-based Concurrent Bio-radiotherapy in High-risk Locally Advanced Oral Squamous Cell Carcinoma (OSCC)


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Oral Cancer

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Trial Information

A Phase II Study of Neoadjuvant Bio-chemotherapy With Cetuximab, Paclitaxel, and Cisplatin (CPC) Followed by Cetuximab-based Concurrent Bio-radiotherapy in High-risk Locally Advanced Oral Squamous Cell Carcinoma (OSCC)


Patients with high-risk, locally advanced (TxN2b~3 or T4N0~3, M0) OSCC will be eligible. To
detect an interested objective response rate (p1) of 80% versus a non-interested response
(p0) rate of 60%, with an α and 1-β of 0.05 and 0.2, respectively (two-sided test),
including the estimated dropout rate of 10%, a total of 47 patients will be recruited.


Inclusion Criteria:



1. High-risk, locally advanced (TxN2b~3 or unresectable T4, M0) OSCC

2. Histologically confirmed squamous cell carcinoma

3. Performance status: Eastern Cooperative Oncology Group performance status (ECOG) 0-1

4. age 18 years or older, less than 70 years of age

5. Having signed informed consent

6. Measurable disease by CT or MRI

7. Adequate hematologic, hepatic and renal function

Exclusion Criteria:

1. Prior radiotherapy for targeted lesions, chemotherapy, EGFR pathway targeting therapy

2. Prior surgery for cancer except for the purpose of diagnostic biopsy

3. Concomitant active 2nd malignancies or disease-free of malignancies < 3 years before
the study except adequately treated in situ cervical cancer, or non-melanoma skin
cancer

4. Concomitant anticancer therapies within the past 28 days

5. Severe cardiopulmonary diseases and other systemic disease under poor control

6. Uncontrolled chronic neuropathy

7. Women who are positive of pregnancy, or in breast-feeding

8. Known allergy to any study treatment

9. Legal incapacity

10. Significant disease which, in the investigator's opinion, would exclude the patient
from the study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint is the overall response rate after completion of the assigned treatment.

Outcome Time Frame:

18 weeks

Safety Issue:

Yes

Principal Investigator

J Y Chang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Health Research of Institutes

Authority:

Taiwan: Institutional Review Board

Study ID:

T1309

NCT ID:

NCT00933387

Start Date:

September 2009

Completion Date:

March 2013

Related Keywords:

  • Oral Cancer
  • oral squamous cell carcinoma
  • neoadjuvant bio-chemotherapy
  • concurrent bio-radiotherapy
  • biomarker
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Mouth Neoplasms

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