ANZCTR - Registration

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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

Condition category

Condition code

Cancer

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]

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]

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]

2-3 months after the completion of chemoradiotherapy

Secondary outcome [1]

Progression-free survival (PFS)

Timepoint [1]

Patients will be followed-up for 3 years after entering the study

Secondary outcome [2]

Overall survival (OS)

Timepoint [2]

Patients will be followed-up for 3 years after entering the study

Secondary outcome [3]

acute toxicity

Timepoint [3]

6 months after study completion. Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc.

Secondary outcome [4]

We will also conduct translational research studies to assess tumor samples for predictive biomarkers.

Timepoint [4]

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?

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]

Greece

State/province [1]

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Hellenic Cooperative Oncology Group

Address [1]

18, Hatzikostandi str, 11524, Athens

Country [1]

Greece

Primary sponsor type

Other Collaborative groups

Name

Hellenic Cooperative Oncology Group

Address

18, Hatzikostandi str, 11524, Athens

Country

Greece

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Eleni Papakostaki

Address

Hellenic Cooperative Oncology Group
18, Hatzikostandi str, 11524 Athens

Country

Greece

Phone

+302106912520

Fax

+302106912713

[email protected]

Contact person for scientific queries

Name

George Fountzilas

Address

"Papageorgiou" Hospital, Nea Efkarpia, Thessaloniki, 564 29

Country

Greece

Phone

+302310693959

Fax

+302310683136

[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
Embase	Expression profiling of 21 biomolecules in locally advanced nasopharyngeal carcinomas of Caucasian patients.	2013	https://dx.doi.org/10.1186/1472-6890-13-1
Embase	The efficacy and safety of induction chemotherapy combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in nasopharyngeal carcinoma patients: A systematic review and meta-analysis.	2020	https://dx.doi.org/10.1186/s12885-020-06912-3
Embase	A Bayesian network meta-analysis of the primary definitive therapies for locoregionally advanced nasopharyngeal carcinoma: IC +CCRT, CCRT+AC, and CCRT alone.	2022	https://dx.doi.org/10.1371/journal.pone.0265551
Embase	Induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: A systematic review and meta-analysis.	2022	https://dx.doi.org/10.3389/fonc.2022.927510

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

Trial Review

Documents added manually

Documents added automatically