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Trial record 4 of 50 for:    Open Studies | "Laryngeal Neoplasms"
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Cetuximab Plus Radiotherapy Versus Cisplatin Plus Radiotherapy in Locally Advanced Head and Neck Cancer (CTXMAB+RT)

This study is currently recruiting participants.
Verified October 2010 by Azienda USL 4 Prato
Sponsor:
Information provided by:
Azienda USL 4 Prato
ClinicalTrials.gov Identifier:
NCT01216020
First received: October 6, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  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 (associated with radiotherapy)
Drug: cisplatin (associated to radiotherapy)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Azienda USL 4 Prato:

Primary Outcome Measures:
  • Compliance [ Time Frame: weekly during treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evaluation and comparison of the event free survival (both local control and distant metastases)

  • acute toxicity [ Time Frame: Weekly during treatment. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Evaluation and comparison of local control

  • cause specific survival [ Time Frame: bimonthly after treatment for two years, then every 6 months ] [ Designated as safety issue: No ]
    Evualation and comparison of cause specific survival

  • overall survival [ Time Frame: bimonthly after treatment for two years, then every 6 months ] [ Designated as safety issue: No ]
    evaluation and comperison of overall survival


Estimated Enrollment: 140
Study Start Date: October 2010
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2013 (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 (associated with radiotherapy)
  • 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.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216020

Contacts
Contact: Stefano M Magrini, Prof ++ 39 0574 4891 ext 302 magrini@med.unibs.it
Contact: Caterina Polli, MD ++ 39 0574 4891 ext 300 cpolli@libero.it

Locations
Italy
Radiotherapy Dept., Arezzo Hospital Not yet recruiting
Arezzo, Italy
Contact: Pietro Ponticelli, MD     ++39 - 0575254 ext 086     p.ponticelli@asl8.toscana.it    
Contact: Luciana Lastrucci, MD     ++39 - 0575254 ext 086     l.lastrucci@asl8.toscana.it    
Principal Investigator: Pietro Ponticelli, MD            
Sub-Investigator: Luciana Lastrucci, MD            
Radiotherapy Dept., Brescia University and Medical Oncology Dept., Brescia Hospital Not yet recruiting
Brescia, Italy, 25100
Contact: Michela Buglione, MD     ++ 39 - 030 3995 ext 271     buglione@med.unibs.it    
Contact: Sandro Tonoli, MD     ++ 39 - 030 3995 ext 271     sandrotonoli@alice.it    
Sub-Investigator: Salvatore Grisanti, MD            
Sub-Investigator: Sandro Tonoli, MD            
Principal Investigator: Michela Buglione, MD            
Radiotherapy Dept., Florence University Not yet recruiting
Firenze, Italy, 50100
Contact: Gianpaolo Biti, Prof.     ++39 - 055 4378 ext 051     biti@dfc.unifi.it    
Contact: Fabiola Paiar, MD     ++39 - 055 4378 ext 051     paiar@dfc.unifi.it    
Principal Investigator: Gianpaolo Biti, Prof            
Sub-Investigator: Fabiola Paiar, MD            
Radiotherapy Dept., Genoa University Not yet recruiting
Genoa, Italy
Contact: Renzo Corvò, Prof.     ++39 - 010 5600 ext 014     renzo.corvo@unige.it    
Contact: Almalina Bacigalupo, MD     ++39 - 010 5600 ext 014     almalina.bacigalupo@istge.it    
Principal Investigator: Renzo Corvò, Prof.            
Sub-Investigator: Almalina Bacigalupo, MD            
Radiotherapy Dept., Azienda USL 4 Prato Recruiting
Prato, Italy, 59100
Contact: Stefano M Magrini, Prof     ++39-0574 4891 ext 302     magrini@med.unibs.it    
Contact: Caterina Polli, MD     ++ 39-0574 4891 ext 300     cpolli@libero.it    
Principal Investigator: Stefano M Magrini, Prof            
Sub-Investigator: Caterina Polli, MD            
Radiotherapy Dept., Siena University Not yet recruiting
Siena, Italy
Contact: Luigi Pirtoli, Prof     ++ 39 - 0577 233390     pritoli@unisi.it    
Contact: Monica Crociani, MD     ++ 39 - 0577 233390     monicacrociani@infinito.it    
Principal Investigator: Luigi Pirtoli, Prof.            
Sub-Investigator: Monica Crociani, MD            
Radiotherapy Dept., Turin University Not yet recruiting
Torino, Italy
Contact: Umberto Ricardi, Prof.     ++39 - 011 6705352     umberto.ricardi@unito.it    
Contact: Monica Rampino, MD     ++39 - 011 6705352     mrampino@molinette.piemonte.it    
Principal Investigator: Umberto Ricardi, Prof.            
Sub-Investigator: Monica Rampino, MD            
Sponsors and Collaborators
Azienda USL 4 Prato
Investigators
Study Chair: Stefano M Magrini, Prof Radiotherapy Dept., Prato Hospital and Brescia University
  More Information

No publications provided

Responsible Party: Prof. Stefano M. Magrini, Radiotherapy Dept., Azienda USL 4 Prato
ClinicalTrials.gov Identifier: NCT01216020     History of Changes
Other Study ID Numbers: eudract 2010-021552-26
Study First Received: October 6, 2010
Last Updated: October 6, 2010
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Azienda USL 4 Prato:
Head and Neck Cancer
Radiotherapy
Cetuximab
Cisplatin

Additional relevant MeSH terms:
Laryngeal Neoplasms
Neoplasms
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Mouth Neoplasms
Pharyngeal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Otorhinolaryngologic Neoplasms
Laryngeal Diseases
 Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Diseases
Cetuximab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013