Trial comparing treatments for Locally Advanced Hypopharyngeal Squamous Cell Carcinoma
Official title Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Advanced Head and Neck Cancer Who Cannot Receive Cisplatin
ClinicalTrials.gov ID: NCT07441681
What this study is testing
What is Carboplatin?
an investigational IV chemotherapy being studied as a potential treatment for locally advanced hypopharyngeal squamous cell carcinoma is designed to kill or stop the growth of cancer cells by forming DNA crosslinks as a platinum-containing compound
Also referred to as Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether cetuximab or standard chemotherapy works better when given with intensity‑modulated radiation therapy for advanced head‑and‑neck cancer.
- Who it's for
- Adults with advanced squamous cell cancer of the mouth, throat, larynx or hypopharynx who are unable to receive cisplatin.
- What's involved
- Participants will receive intensity‑modulated radiation therapy plus either cetuximab (a targeted antibody) or a chemotherapy combo of carboplatin and paclitaxel, along with regular clinic visits and safety tests.
- Time commitment
- Treatment lasts several weeks (about 6‑7 weeks) with multiple visits for radiation, drug infusions, and follow‑up assessments.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have pathologically confirmed, previously untreated, unresected squamous cell carcinoma of the larynx, hypopharynx, oropharynx, or oral...
- Local evaluation of p16 status is required for all oropharynx patients prior to registration
- Local evaluation of p16 status is recommended for non-oropharynx patients prior to registration
- Non-oropharynx and p16-negative oropharynx cancer: American Joint Commission on Cancer (AJCC) 9th edition stage III-IVB
- AJCC 9th Edition TNM: T3 N0 or T1-3 N1 M0; AJCC 9th Edition Stage: III
See the full eligibility criteria
- Patients must have pathologically confirmed, previously untreated, unresected squamous cell carcinoma of the larynx, hypopharynx, oropharynx, or oral cavity
- Local evaluation of p16 status is required for all oropharynx patients prior to registration
- Local evaluation of p16 status is recommended for non-oropharynx patients prior to registration
- Non-oropharynx and p16-negative oropharynx cancer: American Joint Commission on Cancer (AJCC) 9th edition stage III-IVB
- AJCC 9th Edition TNM: T3 N0 or T1-3 N1 M0; AJCC 9th Edition Stage: III
- AJCC 9th Edition TNM: T1-3 N2 or T4a N0-N2 M0; AJCC 9th Edition Stage: IVA
- AJCC 9th Edition TNM: T4b N0-N2 or T1-4b N3 M0; AJCC 9th Edition Stage: IVB
- p16-positive oropharynx cancer: AJCC 9th edition stage II-III
- Eligible p16-Positive Oropharyngeal Primaries
- AJCC 9th Edition TNM: T3 N0-2 or T1-2 N2 M0; AJCC 9th Edition Stage: II
- AJCC 9th Edition TNM: T4 N0-3 or T1-3 N3 M0; AJCC 9th Edition Stage: III
- Imaging of the head and neck with a neck CT or MRI (with contrast, unless contraindicated) or PET/CT which includes diagnostic-quality CT of the neck (with contrast, unless contraindicated)
- Chest imaging: Chest CT (with contrast, unless contraindicated) or PET/CT
- Age ≥ 18
- Complete the online tool at www.nrgoncology.org prior to registration and record the (modified) Charleston Comorbidity Index (CCI), Head and Neck Cancer Intergroup (HNCIG) omega, and G-8 scores on the registration form...
- Creatinine clearance (CrCl) \< 60 mL/min by the Cockroft-Gault formula
- Pre-existing peripheral (sensory or motor) neuropathy grade ≥ 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0)
- Existing need of a hearing aid OR
- ≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated OR
- age ≥ 70 with Head and Neck Cancer Intergroup (HNCIG) omega score \< 0.80 prior to registration OR
- HNCIG omega score \< 0.80
- (Modified) Charlson Comorbidity Index (CCI) ≥ 1
- G-8 score ≤ 14
- Not pregnant and not nursing
- Participants must be able to safely receive the radiation and drug regimens per current Food and Drug Administration (FDA)-approved package insert(s), treating investigator's discretion, and institutional guidelines
- No prior systemic therapy for the study cancer; note that prior systemic therapy for a different cancer is allowable
- No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- No prior surgery for the study cancer
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Anaheim, California, United States
- Baldwin Park, California, United States
- Bellflower, California, United States
- Beverly Hills, California, United States
- Fontana, California, United States
- Harbor City, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Ontario, California, United States
- Palo Alto, California, United States
- Panorama City, California, United States
- Riverside, California, United States
- San Diego, California, United States
- San Jose, California, United States
- San Marcos, California, United States
- Woodland Hills, California, United States
- Newark, Delaware, United States
- Wilmington, Delaware, United States
- Bay Pines, Florida, United States
+ 99 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Anaheim, California, United States; Baldwin Park, California, United States; Bellflower, California, United States; Beverly Hills, California, United States; Fontana, California, United States and 113 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.