A Study of High-Risk Oral Cavity Cancer

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
National 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
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00934739
First received: July 7, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  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.


Condition Intervention Phase
Oral Cavity Cancer
Drug: Thalidomide, Celebrex
Drug: Cyclophosphamide, Dexamethasone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentre,A Phase II/III Randomized Study of Adjuvant Anti-Angiogenesis Therapy for Patients of High-Risk Oral Cavity Cancer

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 448
Study Start Date: June 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934739

Sponsors and Collaborators
National Health Research Institutes, Taiwan
National 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
  More Information

No publications provided

Responsible Party: Chen, Bor-rong / Research Nurse, National Health Research Institutes/Taiwan Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00934739     History of Changes
Other Study ID Numbers: T1306
Study First Received: July 7, 2009
Last Updated: July 7, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
High-Risk Oral Cavity Cancer,
Anti-Angiogenesis

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Cyclophosphamide
Thalidomide
Dexamethasone
Dexamethasone acetate
Celecoxib
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 20, 2014