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Platinum-based Chemotherapy
Pre-Surgery Chemotherapy + Surgery & Radiation for Sinus Cancer
Phase 2
Recruiting
Led By Nabil Saba
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial studies how well chemotherapy works with surgery and radiation therapy compared to surgery and radiation therapy alone for nasal and paranasal sinus cancer.
Who is the study for?
This trial is for adults with nasal and paranasal sinus cancer that can be surgically removed. They should not have had prior radiation for head or neck tumors, no severe allergies to the chemo drugs used, and no other cancers in the last 2 years (except certain skin cancers). Participants need functioning major organs, no serious illnesses that could affect treatment, and women must not be pregnant.Check my eligibility
What is being tested?
The study compares two approaches: one group receives chemotherapy (docetaxel, cisplatin, carboplatin) before surgery and radiation therapy; the other has surgery followed by radiation only. The goal is to see if pre-surgery chemo makes tumors smaller and reduces how much normal tissue needs removal.See study design
What are the potential side effects?
Chemotherapy may cause side effects like nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts. Radiation might lead to skin irritation at the treated site or fatigue. Surgery risks include bleeding and infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is advanced and requires surgery near the eye or skull.
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My surgery team considers my condition operable, with expectations for preserving key facial structures.
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I had skin or cervical cancer before, but it was successfully treated.
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I am not pregnant or breastfeeding.
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I do not have severe numbness or pain in my hands or feet.
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
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Structure preservation rate defined as both skull base and orbit being preserved
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (docetaxel, cisplatin, carboplatin, surgery, IMRT)Experimental Treatment8 Interventions
Patients receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Patients who are ineligible to receive cisplatin receive carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery no later than 6 weeks following the last dose of chemotherapy. Beginning 4-6 weeks after surgery, patients undergo image guided IMRT QD for 5 fractions per week for 30 fractions. Patients with positive margins/positive ECS in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin IV or carboplatin IV weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (surgery, IMRT, cisplatin, carboplatin)Active Control7 Interventions
Patients undergo standard of care surgery. Beginning 4-6 weeks after surgery, patients undergo image guided IMRT QD for 5 fractions per week for 30 fractions. Patients with positive margins/positive ECS in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin IV over 1-2 hours or carboplatin IV over 30 minutes (for patients who are ineligible to receive cisplatin) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Docetaxel
1995
Completed Phase 4
~5620
Image Guided Radiation Therapy
2016
Completed Phase 2
~20
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Find a Location
Who is running the clinical trial?
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,840 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,923 Total Patients Enrolled
Nabil SabaPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured and I've had a scan within the last 2 weeks.I do not have cancer that has spread far or to the lining of my brain.I have not had radiation for tumors in my head, neck, skull base, or brain.I do not have any other serious illnesses that would stop me from receiving cancer treatment.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is advanced and requires surgery near the eye or skull.My surgery team considers my condition operable, with expectations for preserving key facial structures.I had skin or cervical cancer before, but it was successfully treated.I am a woman who can still have children and have not been through menopause for 24 months.I am using or willing to use effective birth control during the study.I am not pregnant or breastfeeding.I have had cancer before, but it hasn't gotten worse in the last 2 years.My health allows me to undergo chemotherapy and surgery.I do not have severe numbness or pain in my hands or feet.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (surgery, IMRT, cisplatin, carboplatin)
- Group 2: Arm B (docetaxel, cisplatin, carboplatin, surgery, IMRT)
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.
What ailment or medical issue does Therapeutic Conventional Surgery commonly address?
"Therapeutic Conventional Surgery is an effective means of treating melanoma, head cancer and soft tissue sarcoma."
Answered by AI
Does this experiment have any available slots for participants?
"This clinical trial, which was brought to light on March 28th 2018, is currently seeking patients. The entry has been updated as recently as December 16th 2021 according to the documents on clinicaltrials.gov"
Answered by AI
Has the FDA sanctioned Therapeutic Conventional Surgery?
"With some evidence to back up its safety, our team at Power assigned Therapeutic Conventional Surgery a rating of 2 on the 1-3 scale. As this is only Phase 2 trial, there are no findings yet that demonstrate efficacy."
Answered by AI
Are there any other scholarly examinations that have looked into the effectiveness of Therapeutic Conventional Surgery?
"Presently, there are 1,398 active studies on Therapeutic Conventional Surgery with 473 of them in the third stage. While most of such trials take place at Shanghai medical centres, 81295 sites globally offer treatments related to this surgery."
Answered by AI
How many healthcare settings are currently administering this experiment?
"This clinical trial is recruiting participants from numerous medical faculties, including Mount Sinai Hospital in Detroit, Michigan, Wayne State University/Karmanos Cancer Institute in Bronx, Montana and Montefiore Medical Center - Moses Campus in Great Falls, Wisconsin."
Answered by AI
What is the upper limit of individuals participating in this research endeavor?
"Indeed, the information available on clinicaltrials.gov indicates that this medical trial is presently recruiting participants. It was initially posted on March 28th 2018 and recently updated on December 16th 2021. 82 individuals from 100 sites are required for successful completion of the study."
Answered by AI
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