We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cetuximab Plus Radiotherapy Versus Cisplatin Plus Radiotherapy in Locally Advanced Head and Neck Cancer (CTXMAB+RT)

This study has been terminated.
(insufficient recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01216020
First Posted: October 7, 2010
Last Update Posted: July 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Università degli Studi di Brescia
Information provided by (Responsible Party):
STEFANO M. MAGRINI, PROF, Azienda USL 4 Prato
  Purpose

BACKGROUND:

Concomitant radiotherapy and cisplatin (CDDP) based chemotherapy is the standard treatment for LA-NHSCC. This combined modality treatment is linked with considerable acute local and systemic toxicity.EGFR is overexpressed in 90-100% of the HNSCC cases and is considered an unfavourable prognostic marker. EGFR costitutive activation is linked with HNSCC pathogenesis.

Cetuximab is a monoclonal anti-EGFR antibody blocking the activation of the receptor and signal transduction. Cetuximab combined with radiotherapy is superior to radiotherapy only in the treatment of LA-HNSCC and is characterized by an acceptable toxicity profile.

RATIONALE:

A direct comparison between concomitant chemoradiotherapy with Cisplatin and the concomitant treatment with radiotherapy associated to cetuximab does not exist.

STUDY DESIGN:

Arm A: Radical radiotherapy (doses and volumes) concomitant with chemotherapy with Cisplatin (40 mg/mq/week) Arm B: Radical radiotherapy (doses and volumes) concomitant with therapy with the monoclonal antibody Cetuximab (400 mg/m2 ["loading dose"] and subsequently 250 mg /m2/week)


Condition Intervention Phase
Head and Neck Neoplasms Laryngeal Neoplasms Mouth Neoplasms Pharyngeal Neoplasms Drug: cetuximab Drug: cisplatin (associated to radiotherapy) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multiinstitutional Open Label Randomized Phase II Study Comparing Cetuximab and Radiotherapy Versus Cisplatin and Radiotherapy as Firstline Treatment for Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA-NHSCC)

Resource links provided by NLM:


Further study details as provided by STEFANO M. MAGRINI, PROF, Azienda USL 4 Prato:

Primary Outcome Measures:
  • Compliance [ Time Frame: weekly during treatment ]
    Evaluation and comparison of the compliance of the two treatments arms


Secondary Outcome Measures:
  • event free survival [ Time Frame: bimonthly for two years, every 6 months thereafter ]
    Evaluation and comparison of the event free survival (both local control and distant metastases)

  • acute toxicity [ Time Frame: Weekly during treatment. ]
    Evaluation and comparison of the grade and incidence of acute toxicity.

  • Local control [ Time Frame: bimonthly for two years after treatment, every six months thereafter ]
    Evaluation and comparison of local control

  • cause specific survival [ Time Frame: bimonthly after treatment for two years, then every 6 months ]
    Evualation and comparison of cause specific survival

  • overall survival [ Time Frame: bimonthly after treatment for two years, then every 6 months ]
    evaluation and comperison of overall survival


Enrollment: 70
Study Start Date: October 2010
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cetuximab plus radiotherapy
Cetuximab given one week before radiotherapy (loading dose, 400 mg/m2) plus weekly (250 mg/m2), concomitant with radiotherapy (7O Gy on clinically involved sites).
Drug: cetuximab
  • Cetuximab is given according to the standard mode of administration: "loading dose" : 400 mg/m2 one week before the start of radiotherapy (week -1), followed by a weekly dose of 250 mg/m2 during the weeks of the treatment with radiotherapy.
  • Radiotherapy: Doses: Clinical sites of disease (T e N) : total dose of 70 Gy given with a fractional dose of 2 Gy/day; "prophylactic" nodal volume (N) : total dose of 50 Gy given with a fractional dose of 2 Gy/day ; Treatment technique: conformal 3D. Intensity modulated radiotherapy (IMRT), also with simultaneous boost (SIB), is allowed.
Other Name: Erbitux
Active Comparator: cisplatin plus radiotherapy
CDDP 40 mg/mq in a single weekly 1-hour infusion concomitant to radiotherapy: (70 Gy to clinically involved sites)
Drug: cisplatin (associated to radiotherapy)
  • CDDP dose: 40 mg/mq in a single weekly 1-hour infusion preceded by adequate hydration, diuretics e antiemetic premedication.
  • Radiotherapy: Doses: Clinical sites of disease (T e N) : total dose of 70 Gy given with a fractional dose of 2 Gy/day; "prophylactic" nodal volume (N) : total dose of 50 Gy given with a fractional dose of 2 Gy/day ; Treatment technique: conformal 3D. Intensity modulated radiotherapy (IMRT), also with simultaneous boost (SIB), is allowed.
Other Name: Cisplatin

Detailed Description:

PRIMARY OBJECTIVES:

Evaluation and comparison of the compliance of the two treatments;

SECONDARY OBJECTIVES:

Evaluation and comparison of the grade and incidence of acute toxicity; Evaluation and comparison of local control; Evaluation and comparison of event free survival (both local control and distant metastases); Evaluation and comparison of cause specific and overall survival.

INCLUSION/EXCLUSION CRITERIA

  • Histologically confirmed squamous cell carcinoma (biopsy obtained from the tumor and/or from its lymphnodal metastases) originating from oral cavity, oropharynx, hypopharinx, supraglottic larynx;
  • Locally advanced disease, defined by one of the following criteria: every T, N+, M0 ( T1, N1 cases excluded); T3-4, N0, M0;
  • Not a nasopharynx, paranasal sinuses, salivary glands tumor;
  • General conditions and concomitant diseases not considered a contraindication for chemotherapy or curative radiotherapy;
  • No other surgical, chemotherapeutic or radiotherapic treatments for ENT region tumors or for tumors of other anatomical sites (with the exception of non-melanoma cutaneous tumors and of the carcinoma in situ of the uterine cervix and of other solid tumors whose primary treatment has been completed more than 3 years before the accrual in this study and never relapsed since primary treatment (the patient having been since then continuously disease- free);
  • Availability for follow-up;
  • Signed informed consent;
  • An interval of maximum 3 weeks between staging procedures for local disease and randomization
  • An interval of maximum 2 weeks between randomization and the onset of the treatment
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma (with biopsy on the primary and / or lymph node metastases) of the oral cavity, oropharynx, hypopharynx, larynx supraglottix;
  • Locally advanced disease, defined by one of the following criteria: any T, N +, M0 (excluding T1, N1), T3-4, N0, M0;
  • Not cancer nasopharynx or paranasal sinuses or salivary glands;
  • General conditions and associated diseases which does not allow to perform chemotherapy or radiotherapy in a radical view;
  • No other surgical treatments, chemotherapy or radiotherapy for cancer of head and neck or elsewhere, except non-melanoma skin cancer or in situ cervical cancer and other solid tumors for which radical treatment has been completed > three years prior to enrollment in the study and for which the patient has remained continuously free of disease;
  • Accessibility to follow-up;
  • Signing of informed consent;
  • Interval between examinations of local staging and randomization, maximum 3 weeks
  • Interval between randomization and initiation of treatment, maximum 2 weeks

Exclusion Criteria:

  • Age <18 years
  • ECOG performance status > 0-1
  • Hemoglobin <9 g / dL
  • Counts of granulocytes, total <1.5 x 10 ^ 9 / L
  • Platelet count <100 x 10 ^ 9 / L
  • Bilirubin> 1.5 times upper limit of normal (ULN)
  • AST or ALT> 3 times ULN
  • Creatinine clearance > 50 mL/min
  • Mg > 0.5 mmol/L
  • Pregnancy or lactation
  • Presence of allergy to study drug or to the excipients used in their formulation
  • Peripheral neuropathy ≥ grade 2 (CTCAE v3.0)
  • Hearing loss / tinnitus ≥ grade 3 (CTCAE v3.0)
  • One of the following conditions:

    • Myocardial infarction within 12 months prior to randomization
    • Severe congestive heart failure
    • Unstable angina
    • Cardiomyopathy in act
    • Ventricular arrhythmia
    • uncontrolled hypertension
    • Severe psychotic disorders in act
    • Severe infection in act
    • Any other serious illness that could interfere with the administration of the therapy provided by the protocol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216020


Locations
Italy
Radiotherapy Dept., Arezzo Hospital
Arezzo, Italy
Radiotherapy Dept., Brescia University and Medical Oncology Dept., Brescia Hospital
Brescia, Italy, 25100
Radiotherapy Dept., Florence University
Firenze, Italy, 50100
Radiotherapy Dept., Genoa University
Genoa, Italy
Radiotherapy Dept., Azienda USL 4 Prato
Prato, Italy, 59100
Radiotherapy Dept., Siena University
Siena, Italy
Radiotherapy Dept., Turin University
Torino, Italy
Sponsors and Collaborators
Azienda USL 4 Prato
Università degli Studi di Brescia
Investigators
Study Chair: Stefano M Magrini, Prof Radiotherapy Dept., Brescia Hospital and Brescia University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: STEFANO M. MAGRINI, PROF, PROF, Azienda USL 4 Prato
ClinicalTrials.gov Identifier: NCT01216020     History of Changes
Other Study ID Numbers: eudract 2010-021552-26
First Submitted: October 6, 2010
First Posted: October 7, 2010
Last Update Posted: July 17, 2015
Last Verified: July 2015

Keywords provided by STEFANO M. MAGRINI, PROF, Azienda USL 4 Prato:
Head and Neck Cancer
Radiotherapy
Cetuximab
Cisplatin

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Laryngeal Neoplasms
Mouth Neoplasms
Pharyngeal Neoplasms
Neoplasms by Site
Otorhinolaryngologic Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Diseases
Cisplatin
Cetuximab
Antineoplastic Agents


To Top