Back to resultsA Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma
Primary Purpose
Oral Cancer
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Cetuximab,Paclitaxel,Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Oral Cancer focused on measuring oral squamous cell carcinoma, neoadjuvant bio-chemotherapy, concurrent bio-radiotherapy, biomarker
Eligibility Criteria
Inclusion Criteria:
- High-risk, locally advanced (TxN2b~3 or unresectable T4, M0) OSCC
- Histologically confirmed squamous cell carcinoma
- Performance status: Eastern Cooperative Oncology Group performance status (ECOG) 0-1
- age 18 years or older, less than 70 years of age
- Having signed informed consent
- Measurable disease by CT or MRI
- Adequate hematologic, hepatic and renal function
Exclusion Criteria:
- Prior radiotherapy for targeted lesions, chemotherapy, EGFR pathway targeting therapy
- Prior surgery for cancer except for the purpose of diagnostic biopsy
- 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
- Concomitant anticancer therapies within the past 28 days
- Severe cardiopulmonary diseases and other systemic disease under poor control
- Uncontrolled chronic neuropathy
- Women who are positive of pregnancy, or in breast-feeding
- Known allergy to any study treatment
- Legal incapacity
- Significant disease which, in the investigator's opinion, would exclude the patient from the study
Sites / Locations
- National Health Research of Institutes, Taiwan Cooperative Oncology Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
open label
Arm Description
an open-labelled, single-arm
Outcomes
Primary Outcome Measures
The primary endpoint is the overall response rate after completion of the assigned treatment.
Secondary Outcome Measures
Secondary endpoints include the response rate after neoadjuvant therapy, progression-free survival, overall survival, biomarker prediction, and toxicity.
Full Information
NCT ID
NCT00933387
First Posted
July 3, 2009
Last Updated
May 3, 2016
Sponsor
National Health Research Institutes, Taiwan
Collaborators
China Medical University Hospital, National Cheng-Kung University Hospital, Chi Mei Medical Hospital, Changhua Christian Hospital, Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00933387
Brief Title
A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Health Research Institutes, Taiwan
Collaborators
China Medical University Hospital, National Cheng-Kung University Hospital, Chi Mei Medical Hospital, Changhua Christian Hospital, Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Surgical resection followed by concurrent chemoradiotherapy is considered as the standard of care for locally advanced OSCC (LAOSCC). Although the treatment could provide prompt local control, but it is also associated with high incidence of distant failure. Systemic chemotherapy given either before (neoadjuvant) or after (adjuvant) definitive local treatment has been extensively evaluated to improve the clinical outcome in LAOSCC. Regimens of taxane/cisplatin-based combinations have been shown to improve the treatment outcome of patients with locally advanced head and neck squamous cell carcinoma (HNSCC) in neoadjuvant setting. Recently, cetuximab (Erbitux®), a monoclonal antibody against epidermal growth factor receptor (EGFR), has also been proven to be an efficient agent for advanced and/or refractory HNSCC with acceptable toxicity profiles. In current study, we shall evaluate the feasibility, efficacy and safety of a triplet bio-chemotherapy consisting of cetuximab, paclitaxel, and cisplatin followed by cetuximab-based concurrent bio-radiotherapy (CBRT) in patients with LAOSCC.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer
Keywords
oral squamous cell carcinoma, neoadjuvant bio-chemotherapy, concurrent bio-radiotherapy, biomarker
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open label
Arm Type
Experimental
Arm Description
an open-labelled, single-arm
Intervention Type
Drug
Intervention Name(s)
Cetuximab,Paclitaxel,Cisplatin
Intervention Description
Cetuximab 500 mg/m2 iv infusion (120 min for the 1st infusion, 90 min for the 2nd , and 60 min for the subsequent) Paclitaxel 120 mg/m2 3-hour iv infusion Cisplatin 50 mg/m2 2-hour iv infusion
Primary Outcome Measure Information:
Title
The primary endpoint is the overall response rate after completion of the assigned treatment.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Secondary endpoints include the response rate after neoadjuvant therapy, progression-free survival, overall survival, biomarker prediction, and toxicity.
Time Frame
>2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
High-risk, locally advanced (TxN2b~3 or unresectable T4, M0) OSCC
Histologically confirmed squamous cell carcinoma
Performance status: Eastern Cooperative Oncology Group performance status (ECOG) 0-1
age 18 years or older, less than 70 years of age
Having signed informed consent
Measurable disease by CT or MRI
Adequate hematologic, hepatic and renal function
Exclusion Criteria:
Prior radiotherapy for targeted lesions, chemotherapy, EGFR pathway targeting therapy
Prior surgery for cancer except for the purpose of diagnostic biopsy
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
Concomitant anticancer therapies within the past 28 days
Severe cardiopulmonary diseases and other systemic disease under poor control
Uncontrolled chronic neuropathy
Women who are positive of pregnancy, or in breast-feeding
Known allergy to any study treatment
Legal incapacity
Significant disease which, in the investigator's opinion, would exclude the patient from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Y Chang, M.D.
Organizational Affiliation
National Health Research of Institutes
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Health Research of Institutes, Taiwan Cooperative Oncology Group
City
Tainan
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma
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