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Anti-tumor antibiotic, Anti-metabolites

Chemotherapy + Radiation for Head and Neck Cancer

Phase 1

Waitlist Available

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically proven head and neck cancer requiring regional radiotherapy

Locoregional, recurrent disease after primary therapy with surgery, radiation, or both OR Stage IV, no prior therapy, and not amenable to conventional therapy with curative intent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well combination chemotherapy plus radiation therapy works in treating patients with head and neck cancer.

Who is the study for?

This trial is for adults over 18 with advanced or recurrent head and neck cancer, who haven't had prior treatment and can't be treated with intent to cure. They should have a decent performance status (able to carry out daily activities), acceptable liver and kidney function tests, no significant infections or severe illnesses, not pregnant or nursing, and willing to use contraception.Check my eligibility

What is being tested?

The study is testing how well combining chemotherapy drugs with radiation therapy works against advanced/recurrent head and neck cancer. It's a Phase I trial which means it's the first step in checking the treatment's safety and effectiveness.See study design

What are the potential side effects?

Potential side effects may include damage to healthy cells leading to symptoms like fatigue, nausea, hair loss from chemotherapy; skin irritation, dry mouth, difficulty swallowing from radiation; plus increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My head or neck cancer diagnosis was confirmed through lab tests and needs radiation.

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My cancer has returned after initial treatment or is at stage IV and cannot be treated with standard curative methods.

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My liver tests are within normal limits.

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I am able to get out of my bed or chair and move around.

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My creatinine level is 2.0 mg/dL or lower.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,153 Total Patients Enrolled

Athanassios Argiris, MDStudy ChairRobert H. Lurie Cancer Center

9 Previous Clinical Trials

241 Total Patients Enrolled

Media Library

Combination Chemotherapy (Anti-tumor antibiotic, Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00004097 — Phase 1

Head and Neck Cancers Research Study Groups:

Head and Neck Cancers Clinical Trial 2023: Combination Chemotherapy Highlights & Side Effects. Trial Name: NCT00004097 — Phase 1

Combination Chemotherapy (Anti-tumor antibiotic, Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00004097 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How hazardous is this therapy for individuals?

"The risk associated with this treatment is classified as low, receiving a safety score of 1. This reflects the fact that it is only in Phase 1 clinical trials and there is limited data regarding its efficacy or safety."

Answered by AI

Does this research study currently have open slots for participants?

"Clinicaltrials.gov reports that this trial is not currently recruiting patients and hasn't been updated since September 19th, 2013. Despite its lack of availability, there are 480 other medical studies enrolling new participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced and/or Recurrent Head and Neck Cancer

1999. "Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced and/or Recurrent Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00004097.

All > Head And Neck Cancer