Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000730202
Ethics application status
Approved
Date submitted
24/07/2009
Date registered
25/08/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Concomitant radiotherapy and weekly cisplatin with or without prior induction chemotherapy with cisplatin, epirubicin and paclitaxel (CEP) in patients with locally advanced nasopharyngeal carcinoma
Scientific title
Induction chemotherapy with cisplatin, epirubicin and paclitaxel (CEP), followed by concomitant radiotherapy and weekly cisplatin versus the same concomitant chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.
A randomized phase II study conducted by the Hellenic Cooperative Oncology Group
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally advanced nasopharyngeal carcinoma 237311 0
Condition category
Condition code
Cancer 239636 239636 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Epirubicin 75 mg/m2 in 20 min infusion followed by paclitaxel 175 mg/m2 in 3-hr infusion, preceded by standard premeditation, on day 1 and cisplatin 75 mg/m2 in 2-hr infusion on day 2. Each cycle will be repeated every 3 weeks.
Cisplatin prehydration
2 liters of glucose 5% solution intravenous (IV) + 6 g of Sodium Chloride (NaCL)/l IV + 2 g Potassium Chloride(KCL)/l IV to be infused in 3 hours.
Mannitol 10% solution 250 ml in 1/2 hour before cisplatin; cisplatin 100 mg/m2 in 125 ml normal saline + 250 ml of mannitol in 1 hour.
Cisplatin posthydration
2 liters of glucose 5% solution + 6 g NaCl/l and 2 g KCl/l.
1 vial/l of magnesium sulphate, in 3 hours.
Cisplatin 40 mg/m2 in 1 hour infusion weekly x 7, 1 h prior to radiotherapy (RT) will be administered during the RT period.
Intervention code [1] 236988 0
Treatment: Drugs
Comparator / control treatment
Cisplatin 40 mg/m2 in 1 hour infusion weekly x 7, 1 h prior to RT will be administered during the RT period.
Control group
Active

Outcomes
Primary outcome [1] 240445 0
Overall response rate (ORR). The ORR will be assessed by imaging methods including computed tomography (CT) scan and magnetic resonance imaging (MRI) of the head and neck region
Timepoint [1] 240445 0
2-3 months after the completion of chemoradiotherapy
Secondary outcome [1] 244951 0
Progression-free survival (PFS)
Timepoint [1] 244951 0
Patients will be followed-up for 3 years after entering the study
Secondary outcome [2] 244953 0
Overall survival (OS)
Timepoint [2] 244953 0
Patients will be followed-up for 3 years after entering the study
Secondary outcome [3] 244954 0
acute toxicity
Timepoint [3] 244954 0
6 months after study completion. Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc.
Secondary outcome [4] 244955 0
We will also conduct translational research studies to assess tumor samples for predictive biomarkers.
Timepoint [4] 244955 0
Research studies will commence following collection of tumour samples for up to 5 years following completion of this study

Eligibility
Key inclusion criteria
Disease characteristics:
1.Biopsy - proven, previously untreated, World Health Organisation (WHO) type I, II or undifferentiated NPC.
2.Stage IIB-IVB [Union Internationale Contre le Cancer (UICC) and the American Joint Committee on Cancer (AJCC)] after pre-therapeutic extensive workup 3.Measurable or evaluable disease required.
3. No synchronous primary tumors.
4. Chest x-ray, bone scan and liver imaging prior to initiation of treatment.
5. Computed tomography (CT) scan and/or Magnetic Resonance Imaging (MRI) of the head and neck region prior to initiation of treatment.
Patient characteristics:
1. Age: 15 years and over.
2. Performance status: WHO 0 - 2
3. Hematopoietic: White Blood Cells (WBC) > 3,500 and platelets >100,000.
4. Renal: creatinine clearance >50 ml/min (measured or calculated) and serum calcium normal.
5. Hepatic: Alkaline phosphatase (ALP) and Serum glutamic oxaloacetic transaminase (SGOT) normal.
6.Cardiovascular: status adequate to tolerate all protocol treatment.
7.Pulmonary: status adequate to tolerate all protocol treatment.
8.Nutritional status: status adequate to tolerate all protocol treatment.
9.Mental status: adequate to follow instructions, keep appointments and provide written informed consent prior to study entry.
10.Life expectancy of at least 3 months.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior therapy:
No prior biologic, chemotherapy, surgery or radiotherapy to the head and neck is allowed.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/10/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
148
Accrual to date
Final
Recruitment outside Australia
Country [1] 1910 0
Greece
State/province [1] 1910 0

Funding & Sponsors
Funding source category [1] 237371 0
Other Collaborative groups
Name [1] 237371 0
Hellenic Cooperative Oncology Group
Country [1] 237371 0
Greece
Primary sponsor type
Other Collaborative groups
Name
Hellenic Cooperative Oncology Group
Address
18, Hatzikostandi str, 11524, Athens
Country
Greece
Secondary sponsor category [1] 236867 0
None
Name [1] 236867 0
Address [1] 236867 0
Country [1] 236867 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The aim of this phase II randomized study was to compare the overall response rate (ORR), the progression-free survival (PFS), the overall survival (OS) and the acute toxicity of previously untreated patients with locally advanced non-nasopharyngeal carcinoma (LA-NPC).Patients were randomized to either 3 cycles of IC with cisplatin 75mg/m2, epirubicin 75mg/m2 and paclitaxel 175mg/m2 (CEP) every 3 weeks followed by definitive radiotherapy 70 Gy and concomitant weekly cisplatin 40mg/m2 (CCRT) or CCRT alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29938 0
Address 29938 0
Country 29938 0
Phone 29938 0
Fax 29938 0
Email 29938 0
Contact person for public queries
Name 13185 0
Eleni Papakostaki
Address 13185 0
Hellenic Cooperative Oncology Group
18, Hatzikostandi str, 11524 Athens
Country 13185 0
Greece
Phone 13185 0
+302106912520
Fax 13185 0
+302106912713
Email 13185 0
hecogoff@otenet.gr
Contact person for scientific queries
Name 4113 0
George Fountzilas
Address 4113 0
"Papageorgiou" Hospital, Nea Efkarpia, Thessaloniki, 564 29
Country 4113 0
Greece
Phone 4113 0
+302310693959
Fax 4113 0
+302310683136
Email 4113 0
fountzil@auth.gr

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
SourceTitleYear of PublicationDOI
EmbaseA Bayesian network meta-analysis of the primary definitive therapies for locoregionally advanced nasopharyngeal carcinoma: IC +CCRT, CCRT+AC, and CCRT alone.2022https://dx.doi.org/10.1371/journal.pone.0265551
EmbaseInduction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: A systematic review and meta-analysis.2022https://dx.doi.org/10.3389/fonc.2022.927510
EmbaseThe efficacy and safety of induction chemotherapy combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in nasopharyngeal carcinoma patients: A systematic review and meta-analysis.2020https://dx.doi.org/10.1186/s12885-020-06912-3
EmbaseExpression profiling of 21 biomolecules in locally advanced nasopharyngeal carcinomas of Caucasian patients.2013https://dx.doi.org/10.1186/1472-6890-13-1
N.B. These documents automatically identified may not have been verified by the study sponsor.