A Study of High-Risk Oral Cavity Cancer

Oral Cavity Cancer Clinical Trial

Official title:

Multicentre，A Phase II/III Randomized Study of Adjuvant Anti-Angiogenesis Therapy for Patients of High-Risk Oral Cavity Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00934739
• Other study ID #: T1306
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: July 7, 2009
• Last updated: February 23, 2015
• Start date: June 2007
• Est. completion date: December 2012

Study information

• Verified date: July 2009
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mouth Neoplasms
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Buddhist Tzu Chi General Hospital, Chang Gung Memorial Hospital, Changhua Christian Hospital, Chi Mei Medical Hospital, Kaohsiung Veterans General Hospital., Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Taiwan University Hospital, Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		7 years	Yes
Secondary	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.		7 years	Yes