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New treatment option for Nasopharyngeal Carcinoma
Official title Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT06682442
What this study is testing
- What it's testing
- This clinical trial tests the effect of induction chemotherapy response-guided radiation (de-escalated intensity-modulated radiation therapy [IMRT]) compared to standard IMRT in patients with Epstein-Barr virus (EBV)-associated nasopharyngeal cancer. Intensity-modulated radiation therapy (IMRT) is an advanced form of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor.
- Time commitment: about 10 years
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
- Participants must have histologically or cytologically confirmed (from primary lesion and/or lymph nodes) nasopharyngeal carcinoma.
- Participants must have Epstein Barr virus (EBV)-associated nasopharyngeal carcinoma, defined as detectable (\> 0 copies/mL) circulating plasma EBV...
- Stage III-IVA disease (American Joint Committee on Cancer [AJCC], 8th edition [ed.]) with no evidence of distant metastasis at the time of diagnosis...
- History/physical examination by a medical oncologist or clinical oncologist or radiation oncologist or otolaryngology (ENT);
- Evaluation of tumor extent with either one of the following:
You likely can't join if
- Prior systemic chemotherapy for nasopharyngeal carcinoma, other than induction chemotherapy (IT); note that prior chemotherapy for a different cancer...
- Prior radiotherapy to the nasopharynx or surrounding involved areas that would result in overlap of radiation therapy fields
- Has participated in a study of an investigational product and received treatment with an investigational drug or used an investigational device...
- Severe, active comorbidity, defined as any of the following:
- Major medical or psychiatric illness that, in the treating investigator's opinion, would interfere with the completion of therapy and follow-up or...
- Unstable angina, congestive heart failure, or peripheral vascular disease requiring hospitalization within the last 12 months; or other cardiac...
See the full eligibility criteria
Who can join
- Participants must have histologically or cytologically confirmed (from primary lesion and/or lymph nodes) nasopharyngeal carcinoma.
- Participants must have Epstein Barr virus (EBV)-associated nasopharyngeal carcinoma, defined as detectable (\> 0 copies/mL) circulating plasma EBV DNA on a qualitative or quantitative polymerase chain reaction...
- Stage III-IVA disease (American Joint Committee on Cancer [AJCC], 8th edition [ed.]) with no evidence of distant metastasis at the time of diagnosis based upon all 3 of the following minimum diagnostic workup criteria:
- History/physical examination by a medical oncologist or clinical oncologist or radiation oncologist or otolaryngology (ENT);
- Evaluation of tumor extent with either one of the following:
- MRI with contrast of the face, nasopharynx, and neck or CT with contrast of the face, nasopharynx and neck with ≤ 3 mm contiguous slices and bone windows to evaluate base of skull involvement; or
- MRI of the nasopharynx and PET/CT (with contrast) of the neck
- Imaging to rule out distant metastasis:
- CT scan with contrast of the chest and abdomen (required) and the pelvis (optional) or a total body PET/CT scan (non-contrast PET/CT is acceptable); and
- Only if clinically indicated: Bone scan only when there is suspicion of bone metastases (a PET/CT scan can substitute for the bone scan)
- Started or planning to start platinum-based induction systemic therapy.
- Planning to receive intensity modulated radiation therapy (IMRT) with concurrent, platinum-based systemic therapy during radiation.
- Use of adjuvant (post-chemoradiation) immunotherapy is permitted.
- Age \>=18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%).
- Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy are eligible for this trial.
- For individuals with evidence of chronic hepatitis B virus (HBV) infection: must be on suppressive therapy, if indicated.
- For individuals with a history of hepatitis C virus (HCV) infection: must be currently on treatment, or must have been treated and cured.
- Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Because the radiation therapy used in this trial is known to be teratogenic, individuals of reproductive potential must agree to use adequate contraception (e.g., hormonal or barrier methods, abstinence) for the...
- Ability to understand and willingness to sign a written informed consent document.
What rules you out
- Prior systemic chemotherapy for nasopharyngeal carcinoma, other than induction chemotherapy (IT); note that prior chemotherapy for a different cancer is permitted
- Prior radiotherapy to the nasopharynx or surrounding involved areas that would result in overlap of radiation therapy fields
- Has participated in a study of an investigational product and received treatment with an investigational drug or used an investigational device within 4 weeks prior to the first dose of treatment
- Severe, active comorbidity, defined as any of the following:
- Major medical or psychiatric illness that, in the treating investigator's opinion, would interfere with the completion of therapy and follow-up or interfere with a full understanding of the risks and potential...
- Unstable angina, congestive heart failure, or peripheral vascular disease requiring hospitalization within the last 12 months; or other cardiac compromise that in the judgment of the treating investigator will preclude...
- Chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization within 30 days prior to registration, or which would preclude safe administration study therapy in the...
- Active, untreated infection and/or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Because the radiation therapy used in this trial is known to be teratogenic, individuals of child-bearing potential must have documentation in their medical record of a negative pregnancy test \ A female participant is...
- Has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause)
- Has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries)
- Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study activities or interfere with participant safety or study...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, 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 10 years 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 San Francisco, California, 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.