WithdrawnPhase 3

Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab

Stopped: change company strategy

Brazil0Started 2013-11

Plain-language summary

Primary: to compare the overall survival defined as the time elapsed between the randomization date and death due to any cause, in both treatment groups. Secondary: to compare the progression-free survival, incidence of locoregional failure, site of the first recurrence/progression, objective response rate assessment, quality of life assessment and incidence of adverse events.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Aged 18 to 75 years old; * Histological or cytological confirmation of SCC in oral cavity, oropharynx, hypopharynx, or larynx; * Stages III or IV disease * Unresectability according to responsible surgeon or medical staff's opinion; * Performance status 0 or 1 * Present indication for radiation therapy and chemotherapy treatment with cisplatin; * Adequate hepatic, renal and medullar functions, indicated by: * Life expectancy above 6 months. Exclusion Criteria * Presence of nasopharyngeal, paranasal sinuses, or salivary glands carcinoma; * Presence of known distant metastasis; * Presence of any other active neoplasm or history of any tumor diagnosed in the last 5 years * Patients with inability to eat normally, in whom a gastric or enteral tubing was not possible at least 2 weeks before their enrollment in the study; * Previous treatment with chemotherapy, radiation therapy, or EGFR inhibitors of any pharmacological class; * Presence of serious comorbidity that, in the investigator's opinion, will put the patient at risk or will jeopardize protocol compliance; * Active known seropositivity for HIV, hepatitis B or C * Presence of a significant neurological or psychiatric disease, as per the investigator's judgment; * Hypersensitivity or allergy to any of the study treatments; * Presence of uncontrolled hypercalcemia; * Pregnancy or breastfeeding; * Female patients of childbearing potential who wish to become pregnant or are unwilling, as well as their pa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall survival

Timeframe: 6 months

Trial details

NCT IDNCT01345084

SponsorEurofarma Laboratorios S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

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