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Alkylating agents
Chemotherapy for Sinus Cancer
Phase 2
Waitlist Available
Led By Ehab Y Hanna
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage II-IV disease; tumor (T) 2-4, node (N) any, metastasis (M) 0
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up u to 5 years
Awards & highlights
Study Summary
This trial is testing docetaxel, cisplatin and fluorouracil to see if they can effectively treat patients with previously untreated stage II-IV nasal cavity and/or paranasal sinus cancer.
Who is the study for?
This trial is for adults with untreated stage II-IV nasal cavity or paranasal sinus cancer. Participants must have certain blood and organ function levels, be able to perform daily activities (ECOG PS 0-1), not have had prior treatments that would exclude them, and women must test negative for pregnancy. People with severe hearing loss, HIV, other cancers treated within the last 3 years, or those who are pregnant or breastfeeding cannot join.Check my eligibility
What is being tested?
The study tests how well a combination of chemotherapy drugs—docetaxel, cisplatin and fluorouracil—works against stage II-IV nasal cavity and paranasal sinus cancer when given before any surgery. The effectiveness will be measured by the ability of these drugs to kill tumor cells or stop them from growing and spreading.See study design
What are the potential side effects?
Possible side effects include reactions to the infusion of drugs like fatigue, nausea, hair loss; damage to organs such as kidneys; nerve damage leading to numbness; increased risk of infection due to low blood cell counts; hearing changes; eye issues related to therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is at stage II-IV, with a tumor size of T2-T4, any node involvement, and no distant metastasis.
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I am fully active or can carry out light work.
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I am capable of becoming pregnant and have a negative pregnancy test.
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My cancer diagnosis is one of the specific types affecting my nasal area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ u to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~u to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical/radiographic complete rate after induction chemotherapy with docetaxel, cisplatin, and fluorouracil
Local tumor control to 80%
Secondary outcome measures
Acute treatment-related toxicity
Biological markers
Disease specific-survival rate
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (docetaxel, cisplatin, and fluorouracil)Experimental Treatment8 Interventions
INDUCTION CHEMOTHERAPY: Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 30-180 minutes or carboplatin IV on day 1, and fluorouracil IV continuously on days 1-4. Cycles repeat every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Patients who achieve CR or PR receive 1 additional course of treatment and undergo chemoradiotherapy over 6-7 weeks. Patients who have SD or PD to induction therapy, or less than a complete response to chemoradiotherapy undergo surgery and radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
FDA approved
Quality-of-Life Assessment
2017
Completed Phase 3
~4950
Carboplatin
FDA approved
Fluorouracil
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
Cisplatin
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,477 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,340 Total Patients Enrolled
Ehab Y HannaPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is at stage II-IV, with a tumor size of T2-T4, any node involvement, and no distant metastasis.Your blood needs to have specific levels of certain components.My cancer has spread to areas below my collarbone.You have been diagnosed with HIV.You need to have specific signs of the disease that can be measured according to certain criteria.You had a bad allergic reaction to certain drugs in the past.Your kidneys work well enough to filter at least 50 milliliters of waste from your blood every minute.You have severe hearing loss in both ears.I have not had chemotherapy in the last 3 years.I had surgery for sinus or nasal cancer and am now free of signs of the disease.I do not have another active cancer or am using experimental drugs.I was treated for another cancer less than 3 years ago.I am fully active or can carry out light work.I am not using or cannot use birth control.I am willing to have hearing and eye tests.I have severe nerve pain or damage.I am capable of becoming pregnant and have a negative pregnancy test.I do not have any untreated or uncontrolled illnesses.My cancer diagnosis is one of the specific types affecting my nasal area.I have had radiation therapy to my sinus or upper neck area.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (docetaxel, cisplatin, and fluorouracil)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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.
How many volunteers are being recruited for this research?
"That is accurate. The study, which began recruiting on June 16th, 2008, is still enrolling patients. 45 participants are needed in total, and they can be seen at a single medical facility."
Answered by AI
To what extent can Chemoradiotherapy help patients with cancer?
"Chemoradiotherapy, which is a common treatment for esophageal neoplasms malignant, can also help patients with advanced endometrial cancer, melanoma, and actinic keratosis."
Answered by AI
Chemoradiotherapy- what side effects do patients experience?
"Chemoradiotherapy received a 2 because, while there is data affirming its safety, there is currently no evidence suggesting that it is an effective treatment."
Answered by AI
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