A Study of High-Risk Oral Cavity Cancer
Overview[ - collapse ][ - ]
Purpose | Objectives: 1. To study the effect of anti-angiogenesis therapy on reducing the recurrence of high-risk oral cavity cancer patients after curative local treatment. 2. To study the toxicity and compliance of post-operative anti-angiogenesis therapy Study design: This is a multi-center randomized controlled phase II/III two-stage study. Study endpoints: The primary endpoint is the tumor-free survival (primary and second primary malignancies) and the primary analysis is to compare the tumor-free survival between groups. |
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Condition | Oral Cavity Cancer |
Intervention | Drug: Thalidomide, Celebrex Drug: Cyclophosphamide, Dexamethasone |
Phase | Phase 2/Phase 3 |
Sponsor | National Health Research Institutes, Taiwan |
Responsible Party | National Health Research Institutes, Taiwan |
ClinicalTrials.gov Identifier | NCT00934739 |
First Received | July 7, 2009 |
Last Updated | July 7, 2009 |
Last verified | July 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | July 7, 2009 |
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Last Updated Date | July 7, 2009 |
Start Date | June 2007 |
Estimated Primary Completion Date | December 2014 |
Current Primary Outcome Measures | The primary endpoint is the tumor-free survival that is defined as the duration between the dates of operation and the date of disease recurrence. [Time Frame: 7 years] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures | Physical examinations, lab abnormality and other toxicities graded by the NCI Common Toxicity Criteria will be examined to evaluate safety profiles of the study treatments. [Time Frame: 7 years] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | A Study of High-Risk Oral Cavity Cancer |
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Official Title | Multicentre,A Phase II/III Randomized Study of Adjuvant Anti-Angiogenesis Therapy for Patients of High-Risk Oral Cavity Cancer |
Brief Summary | Objectives: 1. To study the effect of anti-angiogenesis therapy on reducing the recurrence of high-risk oral cavity cancer patients after curative local treatment. 2. To study the toxicity and compliance of post-operative anti-angiogenesis therapy Study design: This is a multi-center randomized controlled phase II/III two-stage study. Study endpoints: The primary endpoint is the tumor-free survival (primary and second primary malignancies) and the primary analysis is to compare the tumor-free survival between groups. |
Detailed Description | Type and number of patients: Patients with resectable oral cancer of clinical stage N2, 3 or skin-involved T4 will be enrolled. Sample size at the first stage is 64 patients per group and the total sample size at the end of the second stage is 192 patients per group, assuming that the accrual rate/hazard rate = 1.33, an α=0.05 and power of 0.8 (Hypotheses: H0:θ ≦ 1.0 and Ha: θ ≧ 1.33) Treatment schedule: Group A:standard postoperative concurrent chemoradiotherapy. Group B:Immediately after operation starts thalidomide (50) 4# per day and celecoxib (200) 2# bid for three weeks, in addition to standard postoperative concurrent chemoradiotherapy. Group C:Immediately after operation starts cyclophosphamide (50) 1# per day and dexamethasone (0.5) 2# qd for three weeks, in addition to standard postoperative concurrent chemoradiotherapy. |
Study Type | Interventional |
Study Phase | Phase 2/Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Oral Cavity Cancer |
Intervention | Drug: Thalidomide, Celebrex Immediately after operation starts thalidomide (50) 4# per day and celecoxib (Celebrex)(200) 2# bid for three weeks, in addition to standard postoperative concurrent chemoradiotherapy Other Names: Adjuvant TherapyDrug: Cyclophosphamide, Dexamethasone Immediately after operation starts cyclophosphamide (50) 1# per day and dexamethasone (0.5) 2# qd for three weeks, in addition to standard postoperative concurrent chemoradiotherapy |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Enrolling by invitation |
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Estimated Enrollment | 448 |
Estimated Completion Date | December 2014 |
Estimated Primary Completion Date | December 2010 |
Eligibility Criteria | Inclusion Criteria: 1. Histologically proved oral cavity squamous cell carcinoma (buccal and mobile tongue). 2. Clinical stage T4a with skin involvement or resectable N2-3 by UICC/AJCC 1997 staging system.(24) 3. Curative-intent operation feasible and arranged. 4. Eastern Cooperative Oncology Group performance status ≦ 1. 5. A leukocyte count ≧3750/μL, Hb ≧10 g/dL, and a platelet count ≧100,000/μL. 6. A serum bilirubin level < 1.5 UNL (upper normal limit), serum creatinine level < 1.5 UNL or creatinine clearance > 60 mL/min. 7. Age less than 70 years old 8. Informed consent signed. Exclusion Criteria: 1. Evidence of distant metastatic. 2. Presence of another malignancy other than treated squamous/basal cell carcinoma of the skin. 3. Presence of uncontrolled hypertension, poorly controlled heart failure. 4. Presence of active infection. 5. Patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies. 6. Women who test positive for pregnancy. Note: Patients received neck lymph node biopsy will be eligible and the stage will be given according to the preoperative status. |
Gender | Both |
Ages | N/A |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00934739 |
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Other Study ID Numbers | T1306 |
Has Data Monitoring Committee | Yes |
Information Provided By | National Health Research Institutes, Taiwan |
Study Sponsor | National Health Research Institutes, Taiwan |
Collaborators | National Taiwan University Hospital Chang Gung Memorial Hospital Mackay Memorial Hospital Changhua Christian Hospital Sun Yat-sen University National Cheng-Kung University Hospital Kaohsiung Veterans General Hospital. Buddhist Tzu Chi General Hospital Chi Mei Medical Hospital |
Investigators | Principal Investigator: Ruey-Long Hong, MD, PhD. Department of Oncology, National Taiwan University Hospital |
Verification Date | July 2009 |