NCT01472653

Brief Summary

The therapy of patients with locally advanced head and neck cancer will be adjusted to the grade of skin rush as recorded after the first two cycles of Cetuximab and Cisplatin, i.e. either with radioimmunotherapy (radiotherapy and Cetuximab) or radiochemotherapy (radiotherapy and Cisplatin.

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
120

participants targeted

Target at P75+ for phase_2 head-and-neck-cancer

Timeline
Completed

Started Dec 2011

Typical duration for phase_2 head-and-neck-cancer

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

First Submitted

Initial submission to the registry

October 23, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

2.2 years

First QC Date

October 23, 2011

Last Update Submit

December 11, 2011

Conditions

Head and Neck Cancer

Keywords

Head and neck CancerRadiochemotherapyRadioimmunotherapySkin rushlocoregional controlSurvivalToxicity

Outcome Measures

Primary Outcomes (1)

  • locoregional complete response rate

    The primary objective of the study is to determine radiologically the complete response rate 12-14 weeks after therapy.

    12-14 weeks after therapy

Secondary Outcomes (5)

  • feasibility (toxicity profile) of the proposed regimen

    participants will be followed for the duration of treatment (an expected average of 20 weeks)

  • locoregional control

    at 2 years after thapy

  • progression-free survival

    2 years after therapy

  • overall survival

    2 years after therapy

  • late toxicity including thyroid function

    up to 2 years post-therapy

Interventions

cisplatinDRUG

cisplatin 30 mg/m2/week I.V. during radiotherapy

radiotherapyRADIATION

3-dimensional conformal radiotherapy planning and delivery, 35x2 Gy/day over 7 weeks

cetuximabDRUG

cetuximab 400 mg/m2 I.V. 1 week before the start of radiotherapy, cetuximab 250 mg2/week I.V. during radiotherapy

Also known as: Erbitux

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Squamous cell carcinoma, histologically proven (with HPV-status determined in patients with oropharyngeal primary)
  • Tumour site: oral cavity, oropharynx, hypopharynx or larynx.
  • Locally and/or regionally operable and inoperable tumors (UICC TNM stages III, IVa or IVb), without distant metastases (M0-stage)
  • Male or female ≥18 years of age
  • Expected survival \>6 months
  • WHO performance status 0-2
  • Laboratory parameters:
  • hemoglobin ≥100 g/L; leukocyte count \> 3.5x109/L, absolute neutrophil count ≥ 1.5x109/L; platelet count \> 100x109/L; total bilirubin \< 1.25x upper normal limit; transaminases (ALT, AST) \< 5x upper normal limit; creatinine clearance (ECC) ≥ 60 ml/minute;
  • Presence of at least one bidimensionally measurable index lesion
  • Effective contraception for both male and female subjects if risk of conception exists
  • Signed written informed consent

You may not qualify if:

  • Other previous malignancy within 5 years, with exception of a history of a previously adequately treated basal cell carcinoma of the skin or pre- invasive carcinoma of the cervix
  • Chemotherapy ineligibility:
  • unstable cardiopulmonary, renal and liver disease likely to compromise the safe delivery of I.V. infusion (chemotherapy); haematologic diseases; clinically evident hearing impairment; pre-existing motor or sensory neurotoxicity grade ≥ 2 according to the CTCAE v3.0; previous administration of Cetuximab or Cisplatin;
  • Active, uncontrolled infection
  • Medical or psychological condition which in the opinion of the investigator precludes the safe administration of the planned radiotherapy or systemic therapy
  • Known drug abuse or severe alcohol abuse
  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, SI-1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

CisplatinRadiotherapyCetuximab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeuticsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Primož Strojan, Prof.

    Dept. of Radiation Oncology, Institute of Oncology Ljubljana, Slovenia

    PRINCIPAL INVESTIGATOR

  • Branko Zakotnik, Prof.

    Dept. of Medical Oncology, Institute of Oncology Ljubljana, Slovenia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Primož Strojan, Prof.

CONTACT

pstrojan@onko-i.si

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2011

First Posted

November 16, 2011

Study Start

December 1, 2011

Primary Completion

March 1, 2014

Study Completion

December 1, 2016

Last Updated

December 13, 2011

Record last verified: 2011-12

Locations

SL(1)