NCT01301248

Brief Summary

To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further addition of cetuximab experimental treatment

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 17, 2011

Status Verified

April 1, 2011

Enrollment Period

3.1 years

First QC Date

February 22, 2011

Last Update Submit

May 16, 2011

Conditions

Head and Neck NeoplasmsAJCC Stage III/IV

Keywords

locally advanced,unresectable,head and neck squamous cell carcinoma,stage III/IV

Outcome Measures

Primary Outcomes (1)

  • Determine safety and toxicity of combination

    Toxicity is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 1 system.

    Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months

Secondary Outcomes (3)

  • Overall survival time

    Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months

  • Progression-free survival time

    Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months

  • Response

    Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months

Study Arms (2)

Radiotherapy/Cisplatin(GroupA)

ACTIVE COMPARATOR

Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)

Other: Chemoradiation

Radiotherapy/Cisplatin/Cetuximab(GroupB)

EXPERIMENTAL

Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)concurrently with weekly cetuximab 250mg/m2 (following initial loading dose of 400mg/m2 a week before radiotherapy initiation)

Other: Chemoradiation plus Cetuximab

Interventions

Chemoradiation plus CetuximabOTHER

Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)concurrently with weekly cetuximab 250mg/m2 (following initial loading dose of 400mg/m2 a week before radiotherapy initiation)

Also known as: Platinol, Erbitux
Radiotherapy/Cisplatin/Cetuximab(GroupB)
ChemoradiationOTHER

Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2

Also known as: Platinol
Radiotherapy/Cisplatin(GroupA)

Eligibility Criteria

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

You may qualify if:

  • histologically confirmed HNSCC of oral cavity, larynx, oropharynx or
  • hypopharynx; age of 18 years or more
  • adequate liver (SGOT, SGPT, ALP ≤ 3x normal)
  • kidneys (creatinine clearance ≥ 60ml/min
  • heart (no arrythmias, no heart failure) and
  • bone marrow (WBC ≥ 4,000/μL, granulocytes ≥ 1,500/μL, Hb ≥ 10g/dL, platelets ≥ 100,000/μL) function
  • ECOG performance status 0 or 1 and
  • stage III or IVa to b with measurable lesions
  • written informed consent

You may not qualify if:

  • prior radiotherapy
  • chemotherapy
  • concurrent active malignancies
  • pregnancy
  • breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Theagenio Cancer Hospital

Thessaloniki, 54007, Greece

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

ChemoradiotherapyCetuximabCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapyAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Charalambos Andreadis, MD

    Theagenio Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 23, 2011

Study Start

March 1, 2008

Primary Completion

April 1, 2011

Study Completion

June 1, 2011

Last Updated

May 17, 2011

Record last verified: 2011-04

Locations

GR(1)