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Trial registered on ANZCTR

Registration number

ACTRN12611000835943

Ethics application status

Approved

Date submitted

7/08/2011

Date registered

9/08/2011

Date last updated

13/08/2012

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 locally advanced nasopharyngeal carcinoma

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 nasopharyngeal carcinoma

Secondary ID [1]

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Nasopharyngeal carcinoma

Condition category

Condition code

Cancer

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 nasopharyngeal carcinoma.
Fifty eligible patients with pathologically proven locally advanced nasopharyngeal 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 cisplatin (40 mg/m2).

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

This is single arm phase II study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Clinical response rates determined based on the direct laryngoscopic and physical examination and imaging [(Computed Tomography (CT) scan] findings

Timepoint [1]

Direct nasopharyngoscopic 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]

Acute treatment-related toxicities will be measured by clinician assessment and graded according to theWHO common toxicity criteria.

Timepoint [1]

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 nasopharyngeal carcinoma.
2. No prior therapy
3. No clinical or imaging evidence of distant metastasis at the time of study enrollment
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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

15 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

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

Recruiting

Date of first participant enrolment

Anticipated

25/08/2011

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Iran, Islamic Republic Of

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Shiraz University of Medical Sciences

Address [1]

Shiraz University of Medical Sciences, Shiraz 71936-13511, Iran

Country [1]

Iran, Islamic Republic Of

Primary sponsor type

Government body

Name

Shiraz University of Medical Sciences

Address

Shiraz University of Medical Sciences, Shiraz 71936-13511, Iran

Country

Iran, Islamic Republic Of

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Summary

Brief summary

Nasopharyngeal carcinoma (NPC) is a special entity in which the location does not lend itself to curative surgery. NPC is highly radiosensitive, and radical external beam radiotherapy is the mainstay of treatment for this neoplasm and its regional lymph node metastasis. Concurrent cisplatin-based chemoradiation with neoadjuvant or sequential adjuvant chemotherapy is currently the standard care for locoregionally advanced nasopharyngeal carcinoma. Patients with NPC tend to have advanced disease at the time of presentation. Locoregional and systemic failures are high in these patients and contribute to the poor survival. More effective chemotherapeutic regimens and other systemic therapy are needed to decrease the rate of locoregional and distant failure and improve survival. Neoadjuvant chemotherapy followed by concurrent chemoradiation is an alternative choice for these patients. The current clinical trial aimed to investigate the efficacy and safety of neoadjuvant chemotherapy by TPF regimen followed by concurrent chemoradiation with weekly cisplatin in this regard.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Mohammad Mohammadianpanah

Address

Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz 71936-13311, Iran

Country

Iran, Islamic Republic Of

Phone

0098 711 6125170

Fax

0098 711 6474320

[email protected] ; [email protected]

Contact person for scientific queries

Name

Mohammad Mohammadianpanah

Address

Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz 71936-13311, Iran

Country

Iran, Islamic Republic Of

Phone

0098 711 6125170

Fax

0098 711 6474320

[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

Source	Title	Year of Publication	DOI
Dimensions AI	The efficacy and safety of induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF) in treating patients with locally advanced nasopharyngeal carcinoma	2012	https://doi.org/10.1016/j.ejenta.2012.10.004

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically