NCT00934739

Brief Summary

Objectives:

  1. 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. 2.To study the toxicity and compliance of post-operative anti-angiogenesis therapy

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 25, 2015

Status Verified

July 1, 2009

Enrollment Period

5.5 years

First QC Date

July 7, 2009

Last Update Submit

February 23, 2015

Conditions

Oral Cavity Cancer

Keywords

High-Risk Oral Cavity Cancer,Anti-Angiogenesis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (3)

Control

NO INTERVENTION

Standard postoperative concurrent chemoradiotherapy

Thalidomide, Celebrex

EXPERIMENTAL

Adjuvant anti-angiogenesis therapy

Drug: Thalidomide, Celebrex

Cyclophosphamide, Dexamethasone

ACTIVE COMPARATOR

Adjuvant anti-angiogenesis therapy

Drug: Cyclophosphamide, Dexamethasone

Interventions

Thalidomide, CelebrexDRUG

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

Also known as: Adjuvant Therapy
Thalidomide, Celebrex
Cyclophosphamide, DexamethasoneDRUG

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

Cyclophosphamide, Dexamethasone

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

ThalidomideCelecoxibChemotherapy, AdjuvantCyclophosphamideDexamethasone

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBenzenesulfonamidesSulfonamidesAmidesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesCombined Modality TherapyTherapeuticsDrug TherapyPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Ruey-Long Hong, MD, PhD.

    Department of Oncology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 8, 2009

Study Start

June 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 25, 2015

Record last verified: 2009-07