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Alkylating agents
Chemotherapy + Radiation for Head and Neck Cancer
Phase 2
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
Cardiovascular: No clinically significant cardiomyopathy or congestive heart failure
Stage IV carcinoma of the oral cavity, pharynx (including nasopharynx, oropharynx, and hypopharynx), or larynx
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well giving radiation therapy together with chemotherapy works in treating patients with head and neck cancer.
Who is the study for?
This trial is for patients aged 15-80 with advanced, previously untreated mouth, pharynx, or larynx cancer. They should have no distant metastasis and measurable disease is preferred. Participants must have adequate blood counts, liver and kidney function, no significant heart failure or lung dysfunction, not be pregnant/nursing, and cannot have had prior chemotherapy or radiotherapy.Check my eligibility
What is being tested?
The study tests the effectiveness of combining chemotherapy drugs with radiation therapy on patients with advanced head and neck cancers. It's a Phase II trial aiming to see if this combination treatment can better kill tumor cells compared to what's currently available.See study design
What are the potential side effects?
Chemotherapy combined with radiation may cause side effects like fatigue, nausea, hair loss, skin irritation at the radiation site, low blood cell counts leading to infection risk or bleeding problems. Some people might also experience changes in taste or difficulty swallowing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart is healthy without significant issues.
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My cancer is in stage IV and located in my mouth or throat.
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My creatinine level is 2.0 mg/dL or lower.
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My cancer has not spread to distant parts of my body.
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I am between 15 and 80 years old.
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My cancer in the head or neck area is confirmed to be a specific type.
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I can care for myself but may not be able to do active work.
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My lungs work well without any significant problems.
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My cancer is at stage III and is located at the base of my tongue or hypopharynx.
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My liver tests are within the required limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart is healthy without significant issues.I had surgery for my tumor, but it was minor and within the last 3 months.My cancer is in stage IV and located in my mouth or throat.My creatinine level is 2.0 mg/dL or lower.My cancer has not spread to distant parts of my body.I am between 15 and 80 years old.I am currently free of cancer symptoms after having surgery.My cancer in the head or neck area is confirmed to be a specific type.I can care for myself but may not be able to do active work.My lungs work well without any significant problems.I have never undergone chemotherapy.My treatment plan for biologic therapy is not decided.My treatment plan does not specify endocrine therapy.I have not had any prior radiotherapy.My cancer is at stage III and is located at the base of my tongue or hypopharynx.My liver tests are within the required limits.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged sixty and older eligible to partake in this experiment?
"This clinical trial permits participants aged 15-80, according to the specified eligibility requirements."
Answered by AI
Is enrollment still possible for those interested in participating in this experiment?
"According to clinicaltrials.gov, this research is not presently in need of volunteers; the record was initially posted on August 1st 1999 and most recently updated January 3rd 2014. Although no longer looking for applicants, there are 481 other studies actively recruiting participants."
Answered by AI
Has this treatment been approved by the United States Food and Drug Administration?
"The safety of this treatment was deemed a 2 due to the phase 2 nature of the trial, suggesting that while there is some evidence affirming its security, efficacy has yet to be verified."
Answered by AI
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