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Compares treatment options for Head and Neck Cancer
Official title Invert-Prospective Phase II Randomized Trial of Involved Nodal Versus Elective Neck RadioTherapy
ClinicalTrials.gov ID: NCT06477692
What this study is testing
What is ENI using IMRT with or without chemotherapy?
ENI using IMRT with or without chemotherapy is an investigational medicine, being studied as a potential treatment for head and neck cancer.
Also referred to as cisplatin, cetuximab, or carboplatin- paclitaxel).
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
- To determine the risk of solitary elective volume recurrence following involved nodal radiotherapy (INRT) versus elective nodal irradiation (ENI)
- Phase 2: a mid-size study of how well it works
- 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 to 99
You may be able to join if
- Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is...
- Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node...
- Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
- Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
- Age ≥ 18 years.
You likely can't join if
- Distant metastasis.
- Inability to undergo either a diagnostic CT with contrast or simulation CT with contrast.
- Inability to undergo PET-CT.
- Stage I and II glottic carcinoma.
- Gross total excision of both the primary and nodal disease.
- Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and...
See the full eligibility criteria
- Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
- Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (≤ 2 nodes) is also allowable.
- Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
- Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
- Age ≥ 18 years.
- ECOG Performance Status 0-2
- All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for...
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria Has not undergone a hysterectomy...
- Neck CT and/or neck MRI, and PET-CT
- Ability to understand and the willingness to sign a written informed consent.
- Distant metastasis.
- Inability to undergo either a diagnostic CT with contrast or simulation CT with contrast.
- Inability to undergo PET-CT.
- Stage I and II glottic carcinoma.
- Gross total excision of both the primary and nodal disease.
- Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer; in the latter case...
- Prior invasive malignancy with an expected disease-free interval of less than 3 years.
- Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
- people may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
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 - 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 to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.