NCT00941135

Brief Summary

To evaluate the progression free time in patients with completed or partial response \> 30% evaluated over primary tumour (damage T and N) after induction TPF (Docetaxel, Cisplatin, 5-FU) treated with RT + Cetuximab over 2 years.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2009

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
terminated

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

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

4 years

First QC Date

July 15, 2009

Last Update Submit

September 28, 2011

Conditions

Laryngeal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • To evaluate progression-free time in patients with complete or partial response >30% evaluated over primary tumour(T and N) after TPF induction treated with RT + Cetuximab.

    2 years

Interventions

Docetaxel+Cisplatin+5-FU+ Radiotherapy+CetuximabOTHER

Docetaxel:75 mg/m2/d IV Cisplatin:75 mg/m2/d IV 5-FU:750 mg/m2/d IV TPF 3 cycles every 3 weeks Radiotherapy: Total 72 Gy in 42 fractions Cetuximab: 250 mg/m2/d Days 1, 8, 15, 22, 29, 36 and 43

Also known as: TPF (Chemotherapy Regimen code)

Eligibility Criteria

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

You may qualify if:

  • Patient informed consent must be signed before to start the study.
  • Age between 18 to 70 years.
  • Life expectancy \>3 months.
  • Confirmed anatomopathologic diagnosis of local advance scaly larynx or hypolarynx carcinoma III or IV stage without evidence of distance metastasis, which surgery involve a total laryngectomy.
  • T3, T4A, T4B or T2 not candidate to a partial laryngectomy. In case of T2 of both locations it will be required III or IVA stage.
  • Patients in medical conditions to receive neoadjuvant treatment with TPF followed by hyperfractionated radiotherapy combined with cetuximab.
  • Presence of a injury measurable with RECIST criteria.
  • Neutrophils \> or = 1500/mm3, platelets \> or = 150.000/mm3 and haemoglobin \> or =10 g/dL.
  • Renal Function appropriate
  • Hepatic Function appropriate
  • Serum Calcium tight to albumine \< or = 1,25 x upper normal limit (UNL).
  • Nutritional status appropriate: weight loss \< 20% and albumine \> or = 35 g/L.
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

You may not qualify if:

  • Metastatic disease.
  • Surgical treatment, radiotherapy and/or previous chemotherapy.
  • Another tumour locations in head and neck area different from larynx or hypo larynx.
  • Another stages different from III or IVa without distant metastasis and resectable disease.
  • Another previous scaly carcinoma
  • Diagnosis of another neoplasia in last 5 years, except cervix carcinoma in situ and/or basocellular cutaneous carcinoma adequately treated.
  • Active infection treated by ATB IV, including active tuberculosis and VIH.
  • Hypertension not controled defined as systolic \> or = 180 mm Hg and/or diastolic \> or =130 mm Hg at rest.
  • Pregnant/lactating women.
  • Systemic immune treatment, chronic and concomitant, or cancer hormone treatment.
  • Another antineoplastics concomitant treatments.
  • Coronary artery disease or history of heart attack in the last 12 months or high risk of arrythmia uncontrolled or cardiac insufficiency uncontrolled.
  • EPOC that required more than 3 hospitalizations in the last 12 months.
  • Active ulcus not controled.
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Carlos Haya

Málaga, Andalusia, 29010, Spain

Location

Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic Diseases

Study Officials

  • Fernando Arias, MD

    Hospital de Navarra

    PRINCIPAL INVESTIGATOR

  • Ruth Vera, MD

    Hospital de Navarra

    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
SPONSOR

Study Record Dates

First Submitted

July 15, 2009

First Posted

July 17, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

September 29, 2011

Record last verified: 2011-09

Locations

ES(4)