NCT02047201

Brief Summary

To evaluate the safety and efficacy of cisplatin plus intensity-modulated radiotherapy (IMRT) based on FDG-PET/CT after induction chemotherapy (IC) for locally advanced head and neck squamous cell carcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 2, 2016

Status Verified

March 1, 2016

Enrollment Period

2.6 years

First QC Date

January 22, 2014

Last Update Submit

March 1, 2016

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and neck cancerPET/CTinduction chemotherapyIMRT

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS)

    PFS was defined as the time from the first day of IC first cycles to either progression or death.

    24 months after treatment

Secondary Outcomes (5)

  • Tumour metabolic response (MTV) reduction (%)

    2 weeks after IC

  • Total lesion glycolysis (TLG) reduction (%)

    2 weeks after IC

  • SUVmax reductions (%)

    2 weeks after IC

  • Number (%) of participants with adverse events

    12 and 24 months from chemoradiotherapy

  • Overall survival (OS)

    24 months after treatment

Study Arms (1)

Experimental

EXPERIMENTAL

Induction chemotherapy (Docetaxel, Cisplatin and Fluorouracil) following radiochemotherapy (IMRT using PET/CT images after IC for treatment planning + cisplatin iv 40 mg/m2 weekly).

Radiation: IMRTRadiation: PET/CTDrug: DocetaxelDrug: FluorouracilDrug: Cisplatin

Interventions

IMRTRADIATION

IMRT treatment planning using FDG-PET/CT images after induction chemotherapy (IC).

Also known as: intensity-modulated radiation therapy
Experimental
PET/CTRADIATION

Assessing tumor response using FDG-PET/CT.

Also known as: Positron emission tomography-computed tomography
Experimental
DocetaxelDRUG

75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.

Also known as: Taxotere, Docefrez
Experimental
FluorouracilDRUG

750 mg/m2 continuous infusion for 120 h IV (in the vein) every 3 weeks. Number of cycles: 3.

Also known as: 5-Fluorouracil, Adrucil
Experimental
CisplatinDRUG

75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.

Also known as: Platinol
Experimental

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients aged 18 years or over;
  • Histologically confirmed locally advanced (stage III and IV) head and neck squamous cell carcinoma (HNSCC);
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
  • Signed written informed consent approved by the Lithuanian Bioethics Committee (LBEC);

You may not qualify if:

  • Positive serum pregnancy test in women of childbearing potential or breastfeeding;
  • Presence of distant metastasis;
  • Second primary tumor;
  • History of other malignancy within the last 5 years;
  • Recurrent head and neck cancer;
  • Serious uncontrolled concomitant disease that would contraindicate the use of any drugs use in this study as chemotherapy or radiotherapy; ;
  • Inadequate organ function, evidenced by the following laboratory results:
  • Absolute neutrophil count \<1,500 cells/mm3;
  • Platelet count \<100,000 cells/mm3;
  • Hemoglobin \<9 g/dL;
  • Total bilirubin greater than the upper limit of normal (ULN);
  • AST (SGOT) or ALT (SGPT) \>1,5 x ULN;
  • Alkaline phosphatase levels \>2,5 x the ULN;
  • Serum creatinine \>2,0 mg/dl or 177 umol/l.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, LT-44307, Lithuania

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckHead and Neck Neoplasms

Interventions

Radiotherapy, Intensity-ModulatedDocetaxelFluorouracilCisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeuticsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Ilona Kulakiene, Prof.

    Lithuanian University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 28, 2014

Study Start

June 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 2, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

3-7/07/2016 in ASCO (American Society of Clinical Oncology) Annual Meeting, Chicago

Locations

LI(1)