search
Back to results

A Study of High-Risk Oral Cavity Cancer

Primary Purpose

Oral Cavity Cancer

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Thalidomide, Celebrex
Cyclophosphamide, Dexamethasone
Sponsored by
National Health Research Institutes, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Cavity Cancer focused on measuring High-Risk Oral Cavity Cancer,, Anti-Angiogenesis

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Active Comparator

    Arm Label

    Control

    Thalidomide, Celebrex

    Cyclophosphamide, Dexamethasone

    Arm Description

    Standard postoperative concurrent chemoradiotherapy

    Adjuvant anti-angiogenesis therapy

    Adjuvant anti-angiogenesis therapy

    Outcomes

    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.

    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.

    Full Information

    First Posted
    July 7, 2009
    Last Updated
    February 23, 2015
    Sponsor
    National Health Research Institutes, Taiwan
    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
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00934739
    Brief Title
    A Study of High-Risk Oral Cavity Cancer
    Official Title
    Multicentre，A Phase II/III Randomized Study of Adjuvant Anti-Angiogenesis Therapy for Patients of High-Risk Oral Cavity Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2009
    Overall Recruitment Status
    Terminated
    Study Start Date
    June 2007 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Health Research Institutes, Taiwan
    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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Objectives: To study the effect of anti-angiogenesis therapy on reducing the recurrence of high-risk oral cavity cancer patients after curative local treatment. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Cavity Cancer
    Keywords
    High-Risk Oral Cavity Cancer,, Anti-Angiogenesis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Standard postoperative concurrent chemoradiotherapy
    Arm Title
    Thalidomide, Celebrex
    Arm Type
    Experimental
    Arm Description
    Adjuvant anti-angiogenesis therapy
    Arm Title
    Cyclophosphamide, Dexamethasone
    Arm Type
    Active Comparator
    Arm Description
    Adjuvant anti-angiogenesis therapy
    Intervention Type
    Drug
    Intervention Name(s)
    Thalidomide, Celebrex
    Other Intervention Name(s)
    Adjuvant Therapy
    Intervention Description
    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
    Intervention Name(s)
    Cyclophosphamide, Dexamethasone
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically proved oral cavity squamous cell carcinoma (buccal and mobile tongue). Clinical stage T4a with skin involvement or resectable N2-3 by UICC/AJCC 1997 staging system.(24) Curative-intent operation feasible and arranged. Eastern Cooperative Oncology Group performance status ≦ 1. A leukocyte count ≧3750/μL, Hb ≧10 g/dL, and a platelet count ≧100,000/μL. A serum bilirubin level < 1.5 UNL (upper normal limit), serum creatinine level < 1.5 UNL or creatinine clearance > 60 mL/min. Age less than 70 years old Informed consent signed. Exclusion Criteria: Evidence of distant metastatic. Presence of another malignancy other than treated squamous/basal cell carcinoma of the skin. Presence of uncontrolled hypertension, poorly controlled heart failure. Presence of active infection. Patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ruey-Long Hong, MD, PhD.
    Organizational Affiliation
    Department of Oncology, National Taiwan University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of High-Risk Oral Cavity Cancer

    We'll reach out to this number within 24 hrs