NCT00765011

Brief Summary

A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment With TPF Chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

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

Timeline
Completed

Started Oct 2008

Typical duration for phase_2 head-and-neck-cancer

Geographic Reach
1 country

17 active sites

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

First Submitted

Initial submission to the registry

October 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2015

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

5.3 years

First QC Date

October 1, 2008

Last Update Submit

April 9, 2019

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Specific survival free of total laryngectomy

    Time from the start of TPF treatment to death caused by the disease or by the treatment of the disease, or even to surgery involving total laryngectomy. Deaths caused by other reasons were considered "censored" data on the date of death.

    Three years after the end of treatment with radiotherapy and cetuximab

Study Arms (2)

Group A

EXPERIMENTAL

TPF plus concomitant treatment with cetuximab and conventional radiotherapy

Drug: TPF, radiotherapy and cetuximab

Grupo B

OTHER

Surgery

Procedure: H&N surgery

Interventions

TPF, radiotherapy and cetuximabDRUG

3 cycles of: cisplatin: 75mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracilo: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy,divided into daily doses of 2 Gray (total days:35) Cetuximab: 400 mg/m2, i.v, 2 hours, 1 day Cetuximab: 250 mg/m2, i.v, 1 hour, 7 days

Also known as: TPF plus radiotherapy and cetuximab
Group A
H&N surgeryPROCEDURE

Rescue surgery

Also known as: Rescue surgery
Grupo B

Eligibility Criteria

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

You may qualify if:

  • Signed Informed Consent Form.
  • Men or women, age (18 and 70).
  • ECOG scale:0-1.
  • Life expectancy superior to 3 months.
  • Larynx squamous carcinoma histologically demonstrated.
  • Patients with larynx squamous carcinoma, stage III-IVA, with resectable disease whose surgery will imply a total laryngectomy. The T should be a T3, T4A, or a T2 not candidate for a partial laryngectomy. In case of T2 of any of both locations it will be required a III or IVA stadium.
  • Patients to be able to receive treatment with TPF followed by normofractionated radiotherapy with cetuximab.
  • Measurable disease (OMS criteria).
  • Neutrophils superior or equal to 1500/mm3, platelets superior or equal to 150.000/mm3, hemoglobin superior or equal to 10 g/dl.
  • Adequate renal function: creatinin lower or equal to 120 µmol/l (1,4mg/dl)
  • Adequate hepatic function: bilirubin lower or equal to 1 x UNL, AST and ALT lower or equal to 2,5 UNL, alkaline phosphatase lower or equal to 5 UNL.
  • Seric calcium adjusted to albumine lower or equal to 1,25 UNL.
  • Adequate nutritional condition: loss of weight \<20% with relation to the theoretical weight and albumin superior or equal to 35 g/L.
  • Use of an effective contraceptive method.

You may not qualify if:

  • Metastatic disease
  • Surgical treatment, previous radiotherapy and/or chemotherapy for the study disease.
  • Other tumour locations in H\&N that are not larynx.
  • Other stages that are not III or IVa without metastasis and resectable disease.
  • The following cases, which will be considered candidates for radical surgery, will not be included in the study:
  • Tumors of the subglottis.
  • Tumors of glottis or supraglottis with subglottal extension
  • Tumor that destroys the thyroid cartilage and/or cricoid and it extends to thyroid gland or soft necks's tissues.
  • Tumor of supraglottis with a superior extension to 1 cm towards the tongue base (the extension will be measured since the vallecula).
  • Other previous and/or synchronic squamous carcinoma.
  • Diagnosis of another neoplasia in the last 5 years, excepting carcinoma in situ of uterine neck and/or a cutaneous carcinoma basocellular properly treated.
  • Active infection(at needs endovenous antibiotics), including active tuberculosis and diagnosed HIV.
  • Not controlled hypertension defined as arterial systolic tension superior or equal to 180 mm Hg and/or diastolic arterial tension superior or equal to 130 mm Hg baseline.
  • Pregnancy or breastfeeding.
  • Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the cancer.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Hospital de Manresa

Manresa, Barcelona, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, Spain

Location

Hospital Dr.Josep Trueta (ICO Girona)

Girona, 17007, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Spain

Location

Oncogranada

Granada, Spain

Location

Hospital Xeral Calde

Lugo, Spain

Location

Hospital Gregorio Marañon

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario San Carlos

Madrid, Spain

Location

Hospital Son Llátzer

Palma de Mallorca, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Hospital Universitario la Fe de Valencia

Valencia, Spain

Location

Hospital Clínico Universitario de Zaragoza

Zaragoza, Spain

Location

Hospital Miguel Servet

Zaragoza, Spain

Location

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

RadiotherapyCetuximab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TherapeuticsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Ricard Mesía Nin, MD

    Hospital Durán i Reynals

    PRINCIPAL INVESTIGATOR

  • José A. García Sáenz, MD

    Hospital San Carlos, Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2008

First Posted

October 2, 2008

Study Start

October 1, 2008

Primary Completion

February 1, 2014

Study Completion

May 12, 2015

Last Updated

April 11, 2019

Record last verified: 2019-04

Locations

ES(17)