Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000870055
Ethics application status
Approved
Date submitted
14/10/2010
Date registered
18/10/2010
Date last updated
30/09/2012
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 squamous cell carcinoma of the hypopharynx
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 squamous cell carcinoma of the hypopharynx
Secondary ID [1] 252882 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypopharyngeal cancer 258414 0
Condition category
Condition code
Cancer 258580 258580 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 squmous cell carcinoma of the hypopharynx
Fifty eligible patients with pathologically proven hypopharyngeal 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. After 3 courses of neoadjuvant chemotherapy, all Patients proceed to chemoradiotherapy.
Chemoradiotherapy: 3 weeks after completion of neoadjuvant chemotherapy, patients undergo 7 weeks concurrent chemoradiation with weekly intravenous ciplatin (30 mg/m2).
Patients with an incomplete response 4 weeks after completion of treatment proceed to surgery, including pharyngolaryngoesophagectomy.
Intervention code [1] 257409 0
Treatment: Drugs
Comparator / control treatment
This is single arm phase II study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259424 0
Clinical response rates determined based on the direct laryngoscopic and physical examination and imaging [(Computed Tomography (CT) scan] findings
Timepoint [1] 259424 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] 265973 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] 265973 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 hypopharyngeal 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
Active, not recruiting
Date of first participant enrolment
Anticipated
25/05/2011
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] 2973 0
Iran, Islamic Republic Of
State/province [1] 2973 0

Funding & Sponsors
Funding source category [1] 257848 0
University
Name [1] 257848 0
Shiraz University of Medical Sciences
Country [1] 257848 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] 257054 0
None
Name [1] 257054 0
Address [1] 257054 0
Country [1] 257054 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259884 0
Ethics committee address [1] 259884 0
Ethics committee country [1] 259884 0
Date submitted for ethics approval [1] 259884 0
25/10/2010
Approval date [1] 259884 0
Ethics approval number [1] 259884 0

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

Contacts
Principal investigator
Name 31781 0
Address 31781 0
Country 31781 0
Phone 31781 0
Fax 31781 0
Email 31781 0
Contact person for public queries
Name 15028 0
Mohammad Mohammadianpanah
Address 15028 0
Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz 71936-13311, Iran
Country 15028 0
Iran, Islamic Republic Of
Phone 15028 0
0098 711 6125170
Fax 15028 0
0098 711 6474320
Email 15028 0
mohpanah@gmail.com ; mohpanah@sums.ac.ir
Contact person for scientific queries
Name 5956 0
Mohammad Mohammadianpanah
Address 5956 0
Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz 71936-13311, Iran
Country 5956 0
Iran, Islamic Republic Of
Phone 5956 0
0098 711 6125170
Fax 5956 0
0098 711 6474320
Email 5956 0
mohpanah@gmail.com ; mohpanah@sums.ac.ir

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.