CompletedPhase 2

Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer

United StatesStarted 2001-06-06

Plain-language summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy and chemotherapy in treating patients who have stage III or stage IV cancer of the larynx or stage III or stage IV cancer of the oropharynx.

Who can participate

Age range

18 Years – 120 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.

DISEASE CHARACTERISTICS: * Histologically confirmed stage III or IV (T2-T4) squamous cell carcinoma of the larynx or oropharynx * No recurrent disease * No evidence of distant metastasis * Resectable disease, defined as follows: * High probability of attaining clear surgical margins (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall) * No extension to root of tongue (for disease of the base of tongue) * No extension into pterygoid by radiograph (for disease of the tonsil, soft palate, or pharyngeal wall) * No primary tumor or nodal metastases fixed to the carotid artery or cervical spine (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall) * No trismus (for disease of the tonsil, soft palate, or pharyngeal wall) * No involvement of the trachea greater than 1 cm or any involvement of the esophagus (for disease of the subglottis) * For disease of the supraglottis, glottis, or subglottis: * No base of the tongue invasion greater than 2 cm * No tumor extension through cartilage to involve strap muscles of the neck * No tumor fixation to prevertebral fascia * No involvement of the carotid artery * No fixed nodal disease with involvement of the deep neck * Extension into pyriform sinus or lateral pharyngeal wall allowed if no extension into posterior pharynx * Measurable disease * \- Lesions accurately measured in at least one dimension as \> 20 mm (2.0 cm) with conventional techniques…

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

Organ preservation rate

Feasibility and toxicity

Utility of pre- and post-treatment organ function instruments

Disease-free survival and patterns of failure

Objective tumor response rate (complete and partial response)

Changes in quality of life

Correlation of the presence of human papilloma virus infection and p-glycoprotein with outcome

Trial details

NCT IDNCT00014118

SponsorEastern Cooperative Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2007-03

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