Oral Cavity CancerPhase 2/3NCT00934739
A Study of High-Risk Oral Cavity Cancer
A Phase 2/3 study testing Thalidomide, Celebrex and Cyclophosphamide, Dexamethasone in people with Oral Cavity Cancer, run by National Health Research Institutes, Taiwan.
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… Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Oral Cavity Cancer
- What is being tested?
- Thalidomide, Celebrex and Cyclophosphamide, Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Dec 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Multicentre，A Phase II/III Randomized Study of Adjuvant Anti-Angiogenesis Therapy for Patients of High-Risk Oral Cavity Cancer
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.
Read the 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.
- Conditions
- Oral Cavity Cancer
- Being tested
- Thalidomide, Celebrex, Cyclophosphamide, Dexamethasone
- Keywords
- High-Risk Oral Cavity Cancer,, Anti-Angiogenesis
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalidomide, CelebrexDrug
Also called Adjuvant Therapy
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, 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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard postoperative concurrent chemoradiotherapy |
| Thalidomide, Celebrex | Experimental | Adjuvant anti-angiogenesis therapy Receives: Drug: Thalidomide, Celebrex |
| Cyclophosphamide, Dexamethasone | Active comparator | Adjuvant anti-angiogenesis therapy Receives: Drug: Cyclophosphamide, Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJun 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cavity CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Ruey-Long Hong, MD, PhD., Principal investigator, Department of Oncology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934739
- Sponsor's protocol ID
- T1306
- Status last verified
- Jul 2009
- First submitted
- 7 Jul 2009
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre，A Phase II/III Randomized Study of Adjuvant Anti-Angiogenesis Therapy for Patients of High-Risk Oral Cavity Cancer
- ClinicalTrials.gov ID
- NCT00934739
- Acronym / sponsor ID
- T1306
- Conditions
- Oral Cavity Cancer
- Keywords
- High-Risk Oral Cavity Cancer,, Anti-Angiogenesis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- 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
- Study start
- Jun 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard postoperative concurrent chemoradiotherapy |
| Thalidomide, Celebrex | Experimental | Drug: Thalidomide, CelebrexAdjuvant anti-angiogenesis therapy |
| Cyclophosphamide, Dexamethasone | Active comparator | Drug: Cyclophosphamide, DexamethasoneAdjuvant anti-angiogenesis therapy |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thalidomide, CelebrexAlso: Adjuvant TherapyImmediately after operation starts thalidomide (50) 4# per day and celecoxib (Celebrex)(200) 2# bid for three weeks, in addition to standard postoperative concurrent chemoradiotherapy | Drug | Thalidomide, Celebrex |
| Cyclophosphamide, DexamethasoneImmediately after operation starts cyclophosphamide (50) 1# per day and dexamethasone (0.5) 2# qd for three weeks, in addition to standard postoperative concurrent chemoradiotherapy | Drug | Cyclophosphamide, Dexamethasone |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruey-Long Hong, MD, PhD. principal investigator
Department of Oncology, National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Thalidomide, Celebrex and Cyclophosphamide, Dexamethasone in people with Oral Cavity Cancer, run by National Health Research Institutes, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2015.