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New treatment option for Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma...
Official title Evaluating a Decreased Dose of Radiation Therapy to the Elective Neck for the Treatment of HPV-Related Oropharyngeal Cancer, ENLIGHT Trial
ClinicalTrials.gov ID: NCT07178301
What this study is testing
- What it's testing
- This clinical trial evaluates how decreasing the dose of radiation to the elective neck (areas of lymph nodes not directly involved in the cancer) impacts treatment outcomes in patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 7 weeks
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
- 3.1.1 Patients must have a histologically confirmed HPV-related OPSCC, confirmed by HPV insitu hybridization.
- 3.1.2 Patients must not have received prior treatment (i.e., no induction chemotherapy).
- 3.1.3 Patients must have evaluable disease (per RECIST v1.1 response criteria). See Section 6.
- 3.3 for the evaluation of measurable disease.
- 3.1.4 Patients must be age ≥ 18 years.
You likely can't join if
- 3.2.1 Patients with cT4, cN3, or cM1 disease by AJCC 8 th edition.
- 3.2.2 Patients who have had prior RT to the head/neck region that would result in overlap of RT fields.
- 3.2.3 Patients who have had prior major surgery to the head/neck region that could disrupt lymphatic flow as determined by the PI.
- 3.2.4 Patients who have an uncontrolled intercurrent illness that would interfere with the receipt of RT including, but not limited to any of the...
See the full eligibility criteria
- 3.1.1 Patients must have a histologically confirmed HPV-related OPSCC, confirmed by HPV insitu hybridization.
- 3.1.2 Patients must not have received prior treatment (i.e., no induction chemotherapy).
- 3.1.3 Patients must have evaluable disease (per RECIST v1.1 response criteria). See Section 6.
- 3.3 for the evaluation of measurable disease.
- 3.1.4 Patients must be age ≥ 18 years.
- 3.1.5 Patients must have AJCC 8 th edition Stage I-II disease, as defined by a T-classification of T1-3, and N-classification of N1-2, without metastases (M0), as defined by physical examination (including...
- 3.1.6 Patient must receive a staging PET scan prior to registration on study.
- 3.1.7 Patients must exhibit an ECOG performance status of 0-1. Please refer to Appendix A ECOG Performance Status Scale.
- 3.1.8 Patients may be planned to undergo RT alone or RT with concurrent chemotherapy, with chemotherapy managed at the discretion of the treating medical oncologist per standard of care.
- 3.1.9 RT is known to be teratogenic to a developing human fetus. For this reason, patients of child-bearing potential (POCBP) must agree to use adequate contraception (hormonal or barrier method of birth control...
- 3.1.10 POCBP must have a negative pregnancy test prior to CT simulation or sign the Department of Radiation Oncology's standard pregnancy testing declination form. Note: the timing of the pregnancy test/declination form...
- 3.1.11 Patients must have the ability to understand and the willingness to sign a written informed consent document prior to registration.
- 3.2.1 Patients with cT4, cN3, or cM1 disease by AJCC 8 th edition.
- 3.2.2 Patients who have had prior RT to the head/neck region that would result in overlap of RT fields.
- 3.2.3 Patients who have had prior major surgery to the head/neck region that could disrupt lymphatic flow as determined by the PI.
- 3.2.4 Patients who have an uncontrolled intercurrent illness that would interfere with the receipt of RT including, but not limited to any of the following, are not eligible: Uncontrolled connective tissue disorders...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Warrenville, Illinois, 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 study runs about 7 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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?
Study sites include Chicago, Illinois, United States; Warrenville, Illinois, 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.