Suspended

A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer

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What is being tested

Placebo

+ Erlotinib
+ Standard of care
Drug
Other
Who is being recruted

Head and Neck Cancer

Over 18 Years
+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 3
Interventional
Study Start: November 2006

See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: November 25, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2006Actual date on which the first participant was enrolled.

This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo in participants with resected head and neck squamous cell cancer who are receiving concurrent chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease progression or unacceptable toxicity.

Official TitlePhase III Randomized, Controlled Trial of Erlotinib (Tarceva) as Maintenance Therapy in Patients With Squamous Cell Carcinoma of the Head and Neck Treated With Resection and Radiotherapy With or Without Concomitant Chemotherapy With Curative Aim 
Principal SponsorHoffmann-La Roche
Last updated: November 25, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
94 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Head and Neck Cancer
Criteria
3 inclusion criteria required to participate
Adults greater than or equal to (≥) 18 years of age
Curatively treated head and neck squamous cell cancer with T3-T4 and/or N2-N3 pathology, with or without other findings of poor prognosis such as extranodal extension, positive resection margins, and perineural or vascular involvement
Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
2 exclusion criteria prevent from participating
Macroscopic residual disease after surgery
Previous treatment with anti-epidermal growth factor receptor (anti-EGFR) targeted therapies

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive erlotinib tablets as 150 mg PO daily for 1 year until disease progression or intolerable toxicity.
Group II
Placebo
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity.
Study Objectives
Primary Objectives

Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The number of participants who experienced disease progression was reported.

Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. TTP was defined as the time from inclusion in the study to the time of disease progression, appearance of second tumor, or death from any cause, whichever occurred first. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The median duration of TTP and corresponding 95% confidence interval (CI) were to be estimated by Kaplan-Meier analysis and expressed in months.
Secondary Objectives

The number of participants who died from any cause was reported.

OS was defined as the time from inclusion in the study to date of death for any reason. The median duration of OS and corresponding 95% CI were to be estimated by Kaplan-Meier analysis and expressed in months.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 31 locations
Suspended
Unknown FacilityAlcorcon, SpainSee the location
Suspended
Unknown FacilityBarcelona, Spain
Suspended
Unknown FacilityBarcelona, Spain
Suspended
Unknown FacilityBarcelona, Spain
Suspended31 Study Centers