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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Pharyngeal Neoplasms

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Trial Information

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)


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compliance

Outcome Description:

Evaluation and comparison of the compliance of the two treatments arms

Outcome Time Frame:

weekly during treatment

Safety Issue:

No

Principal Investigator

Stefano M Magrini, Prof

Investigator Role:

Study Chair

Investigator Affiliation:

Radiotherapy Dept., Prato Hospital and Brescia University

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

eudract 2010-021552-26

NCT ID:

NCT01216020

Start Date:

October 2010

Completion Date:

October 2016

Related Keywords:

  • Head and Neck Neoplasms
  • Laryngeal Neoplasms
  • Mouth Neoplasms
  • Pharyngeal Neoplasms
  • Head and Neck Cancer
  • Radiotherapy
  • Cetuximab
  • Cisplatin
  • Neoplasms
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Neoplasms
  • Mouth Neoplasms
  • Pharyngeal Neoplasms

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