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Trial registered on ANZCTR


Registration number
ACTRN12610000856011
Ethics application status
Not yet submitted
Date submitted
9/10/2010
Date registered
14/10/2010
Date last updated
14/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Combined neoadjuvant chemotherapy docetaxel (Taxotere), cisplatin and 5-Fluorouracil and concurrent chemoradiation in treating patients with locally advanced cancer of the larynx
Scientific title
The efficacy and safety of combined neoadjuvant chemotherapy with docetaxel, cisplatin and 5-Fluorouracil (5-FU) [TPF regimen] and concurrent chemoradiation in treating patients with locally advanced cancer of the larynx
Secondary ID [1] 252839 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and neck cancer 258349 0
laryngeal cancer 258350 0
Condition category
Condition code
Cancer 258533 258533 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
single arm phase II study evaluating the efficacy and safety of the combined neoadjuvant chemotherapy with intravenous docetaxel (Taxotere), cisplatin and 5-Fluorouracil (5-FU) [TPF regimen; T: Taxotere, P: Cisplatin F: 5-FU] and concurrent chemoradiation with weekly intravenous cisplatin in patients with locally advanced laryngeal carcinoma
Fifty eligible patients with pathologically proven laryngeal carcinoma are enrolled.
Neoadjuvant chemotherapy: Patients initially receive neoadjuvant chemotherapy comprising intravenous docetaxel (75 mg/m2) and intravenous cisplatin (100 mg/m2) on day 1 and intravenous 5-FU (750 mg/m2) continuously on days 1-3. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete or partial response after 3 courses of neoadjuvant chemotherapy proceed to chemoradiotherapy. Patients with less than a partial response after course 3 proceed to surgery, including total laryngectomy.
Chemoradiotherapy: 3 weeks after completion of neoadjuvant chemotherapy, patients undergo 7 weeks concurrent chemoradiation with weekly intravenous ciplatin (30 mg/m2).
Intervention code [1] 257359 0
Treatment: Drugs
Comparator / control treatment
This is single arm phase II study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259372 0
Clinical response rates determined based on the direct laryngoscopic and physical examination and imaging [(Computed Tomography (CT) scan] findings
Timepoint [1] 259372 0
Direct laryngoscopic and physical examination and imaging (CT scan) will be performed 3 weeks after the last (3rd) cycle of neoadjuvant chemotherapy and 4 weeks following completion of chemoradiation.
Secondary outcome [1] 265889 0
Acute treatment-related toxicities will be measured by clinician assessment and graded according to the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer(RTOG/EORTC) Late Radiation Morbidity Scoring Schema.
Timepoint [1] 265889 0
Acute treatment-related toxicites [such as hematologic (leukopenia, anemia, thrombocytopenia), gastrointestinal (diarrhea, vomiting), neurological (neuropathy, pain, hand foot syndrome) toxicities] will be assessed at baseline, at the end of every sequential neoadjuvant chemotherapy cycle and weekly during concurrent chemoradiotherapy.

Eligibility
Key inclusion criteria
1. Pathologically proven locally advanced laryngeal carcinoma.
2. No prior therapy
3. No clinical or imaging evidence of distant metastasis at the time of study enrollment
4. Karnofsky performance status greater than or equal to 70
5. Written informed consent
6. Normal or acceptable liver, kidney and bone marrow function (Absolute neutrophil count greater than or equal to 1,500/mm3
Platelet count greater than or equal to 100,000/mm3
Bilirubin < 1.5 times the upper limit of the normal range
Alkaline phosphatase and transaminases < 2.5 times the upper limit of the normal range
Serum creatinine < 1.7 mg/dL)
Females must not be pregnant or lactating
Minimum age
20 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior therapy 2. Clinical or imaging evidence of distant metastasis 3. Patients with a known contraindication (such as allergy to taxan drugs,
5. Patients must have
normal cardiac function [Left ventricular ejection fraction (LVEF) assessed by Multigated radionuclide angiography (MUGA) or echocardiography (ECHO) and clinically satisfactory 12-lead electrocardiography (ECG)
No serious cardiac illness or medical condition within the past 6 months including, but not limited to, any of the following:
History of documented congestive heart failure
High-risk uncontrolled arrhythmias
Angina pectoris requiring antianginal medication
Clinically significant valvular heart disease
Evidence of transmural infarction on ECG
Poorly controlled hypertension (e.g., systolic blood presure (BP) > 180 mm Hg or diastolic BP > 100 mm Hg)]
6. Patients with severe liver, renal, inflammatory intestinal or blood coagulation disorders,

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2958 0
Iran, Islamic Republic Of
State/province [1] 2958 0
Fars

Funding & Sponsors
Funding source category [1] 257809 0
University
Name [1] 257809 0
Shiraz University of Medical Sciences
Country [1] 257809 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shiraz University of Medical Sciences
Address
Shiraz University of Medical Sciences, Shiraz 71936, Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 257014 0
None
Name [1] 257014 0
Address [1] 257014 0
Country [1] 257014 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259849 0
Ethics committee address [1] 259849 0
Ethics committee country [1] 259849 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 259849 0
01/11/2010
Approval date [1] 259849 0
Ethics approval number [1] 259849 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31748 0
Address 31748 0
Country 31748 0
Phone 31748 0
Fax 31748 0
Email 31748 0
Contact person for public queries
Name 14995 0
Mohammad Mohammadianpanah
Address 14995 0
Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz 71936-13311, Iran
Country 14995 0
Iran, Islamic Republic Of
Phone 14995 0
0098 711 6125170
Fax 14995 0
0098 711 6474320
Email 14995 0
[email protected] ; [email protected]
Contact person for scientific queries
Name 5923 0
Mohammad Mohammadianpanah
Address 5923 0
Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz 71936-13311, Iran
Country 5923 0
Iran, Islamic Republic Of
Phone 5923 0
0098 711 6125170
Fax 5923 0
0098 711 6474320
Email 5923 0
[email protected] ; [email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.