Clinical Trial: Cetuximab Plus Radiotherapy Versus Cisplatin Plus Radiotherapy in Locally Advanced Head and Neck Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 C

Brief Summary:

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)


Detailed Summary:

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;

  • Sponsor: Azienda USL 4 Prato

    Current Primary Outcome: Compliance [ Time Frame: weekly during treatment ]

    Evaluation and comparison of the compliance of the two treatments arms


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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


    Original Secondary Outcome: Same as current

    Information By: Azienda USL 4 Prato

    Dates:
    Date Received: October 6, 2010
    Date Started: October 2010
    Date Completion: December 2019
    Last Updated: July 16, 2015
    Last Verified: July 2015