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.
ConditionOral Cavity Cancer
InterventionDrug: Thalidomide, Celebrex
Drug: Cyclophosphamide, Dexamethasone
PhasePhase 2/Phase 3
SponsorNational Health Research Institutes, Taiwan
Responsible PartyNational Health Research Institutes, Taiwan
ClinicalTrials.gov IdentifierNCT00934739
First ReceivedJuly 7, 2009
Last UpdatedJuly 7, 2009
Last verifiedJuly 2009

Tracking Information[ + expand ][ + ]

First Received DateJuly 7, 2009
Last Updated DateJuly 7, 2009
Start DateJune 2007
Estimated Primary Completion DateDecember 2014
Current Primary Outcome MeasuresThe 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 MeasuresPhysical 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 TitleA Study of High-Risk Oral Cavity Cancer
Official TitleMulticentre,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 TypeInterventional
Study PhasePhase 2/Phase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionOral Cavity Cancer
InterventionDrug: 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)
  • No Intervention: Control
    Standard postoperative concurrent chemoradiotherapy
  • Experimental: Thalidomide, Celebrex
    Adjuvant anti-angiogenesis therapy
  • Active Comparator: Cyclophosphamide, Dexamethasone
    Adjuvant anti-angiogenesis therapy

Recruitment Information[ + expand ][ + ]

Recruitment StatusEnrolling by invitation
Estimated Enrollment448
Estimated Completion DateDecember 2014
Estimated Primary Completion DateDecember 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.
GenderBoth
AgesN/A
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00934739
Other Study ID NumbersT1306
Has Data Monitoring CommitteeYes
Information Provided ByNational Health Research Institutes, Taiwan
Study SponsorNational Health Research Institutes, Taiwan
CollaboratorsNational 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 DateJuly 2009