A Study of High-Risk Oral Cavity Cancer

NCT ID: NCT00934739

Last Updated: 2015-02-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2012-12-31

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.

Conditions

Oral Cavity Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Standard postoperative concurrent chemoradiotherapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Thalidomide, Celebrex

Adjuvant anti-angiogenesis therapy

Group Type: EXPERIMENTAL

Thalidomide, Celebrex

Intervention Type: DRUG

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

Cyclophosphamide, Dexamethasone

Adjuvant anti-angiogenesis therapy

Group Type: ACTIVE_COMPARATOR

Cyclophosphamide, Dexamethasone

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Adjuvant Therapy

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.

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

Mackay Memorial Hospital

OTHER

Sponsor Role: collaborator

Changhua Christian Hospital

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role: collaborator

Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role: collaborator

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role: collaborator

Chi Mei Medical Hospital

OTHER

Sponsor Role: collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruey-Long Hong, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, National Taiwan University Hospital

Other Identifiers

T1306

Identifier Type: -

Identifier Source: org_study_id