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


Phase 2/Phase 3
N/A
70 Years
Open (Enrolling by invite only)
Both
Oral Cavity Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

7 years

Safety Issue:

Yes

Principal Investigator

Ruey-Long Hong, MD, PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, National Taiwan University Hospital

Authority:

Taiwan: Department of Health

Study ID:

T1306

NCT ID:

NCT00934739

Start Date:

June 2007

Completion Date:

December 2014

Related Keywords:

  • Oral Cavity Cancer
  • High-Risk Oral Cavity Cancer,
  • Anti-Angiogenesis
  • Mouth Neoplasms

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