A Study of High-Risk Oral Cavity Cancer
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|ClinicalTrials.gov Identifier: NCT00934739|
Recruitment Status : Terminated
First Posted : July 8, 2009
Last Update Posted : February 25, 2015
- To study the effect of anti-angiogenesis therapy on reducing the recurrence of high-risk oral cavity cancer patients after curative local treatment.
- To study the toxicity and compliance of post-operative anti-angiogenesis therapy
This is a multi-center randomized controlled phase II/III two-stage study.
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.
|Condition or disease||Intervention/treatment||Phase|
|Oral Cavity Cancer||Drug: Thalidomide, Celebrex Drug: Cyclophosphamide, Dexamethasone||Phase 2 Phase 3|
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)
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 (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentre，A Phase II/III Randomized Study of Adjuvant Anti-Angiogenesis Therapy for Patients of High-Risk Oral Cavity Cancer|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
No Intervention: Control
Standard postoperative concurrent chemoradiotherapy
Experimental: Thalidomide, Celebrex
Adjuvant anti-angiogenesis therapy
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 Name: Adjuvant Therapy
Active Comparator: Cyclophosphamide, Dexamethasone
Adjuvant anti-angiogenesis therapy
Drug: 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
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934739
|Principal Investigator:||Ruey-Long Hong, MD, PhD.||Department of Oncology, National Taiwan University Hospital|