Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Progression-Free Survival Rate (PFS) at 2 years post radiation
研究概览
简要总结
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. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Radiation therapy sometimes causes unwanted symptoms or side effects, including late effects such as hearing loss and dental problems. The severity of the side effects is related to the radiation dose received and the amount of tissue that received radiation. De-escalation IMRT uses lower doses of radiation based on a good response to induction chemotherapy. Giving de-escalated IMRT may be as effective as standard doses of IMRT in treating patients with EBV-associated nasopharyngeal cancer.
详细描述
PRIMARY OBJECTIVE:
I. To measure the proportion of participants alive without progression of disease two years following induction therapy (IT) response-guided IMRT.
SECONDARY OBJECTIVES:
I. To assess the 1-year rate of progression-free survival (PFS) after IT response-guided IMRT.
II. To assess the 1- and 2-year cumulative incidence of locoregional recurrence (LRR) after IT response-guided IMRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 (PCR)-based test.
- •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 efficacy assessment of the investigational regimen are eligible for this trial.
- •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 duration of study participation and for at least 60 days after the last administration of radiation therapy. Should a study participant or their partner become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •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 complications of the therapy
- •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 safe administration of study treatment
- •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 opinion of the treating investigator
- •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 considered to NOT be of child-bearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if the participant meets either of the following two criteria:
- •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 endpoints
研究组 & 干预措施
Arm I (de-escalated Intensity Modulated Radiation Therapy (IMRT)
Participants undergo de-escalated IMRT every day (QD) 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, PET, PET/CT, CT, and/or bone scans as well as providing blood samples throughout the trial.
干预措施: Intensity-Modulated Radiation Therapy (IMRT) (Radiation)
Arm I (de-escalated Intensity Modulated Radiation Therapy (IMRT)
Participants undergo de-escalated IMRT every day (QD) 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, PET, PET/CT, CT, and/or bone scans as well as providing blood samples throughout the trial.
干预措施: Radiographic Imaging (Procedure)
Arm I (de-escalated Intensity Modulated Radiation Therapy (IMRT)
Participants undergo de-escalated IMRT every day (QD) 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, PET, PET/CT, CT, and/or bone scans as well as providing blood samples throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Arm II (standard IMRT)
Patients undergo standard IMRT QD 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, PET, PET/CT, CT, and/or bone scans as well as providing blood samples throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Arm II (standard IMRT)
Patients undergo standard IMRT QD 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, PET, PET/CT, CT, and/or bone scans as well as providing blood samples throughout the trial.
干预措施: Intensity-Modulated Radiation Therapy (IMRT) (Radiation)
Arm II (standard IMRT)
Patients undergo standard IMRT QD 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, PET, PET/CT, CT, and/or bone scans as well as providing blood samples throughout the trial.
干预措施: Radiographic Imaging (Procedure)
结局指标
主要结局
Progression-Free Survival Rate (PFS) at 2 years post radiation
时间窗: Up to 26 months
PFS is defined as the proportion of participants alive without progression of disease from the first day of radiotherapy to progression or death by any cause, whichever occurs first, assessed up to 2 years after the last day of radiation therapy. The Kaplan-Meier method will be used to estimate the PFS rate along with a 90% confidence interval.
次要结局
- Progression-Free Survival Rate (PFS) at 1 year post radiation(Up to 14 months)
- Locoregional recurrence rate (LRR) at 1 year post radiation(Up to 14 months)
- Locoregional recurrence rate (LRR) at 2 years post radiation(Up to 26 months)
- Incidence of Distant metastasis (DM) at 1 year post radiation(Up to 14 months)
- Incidence of Distant metastasis (DM) at 2 years post radiation(Up to 26 months)
- Median Overall Survival (OS) at 1 year post radiation(Up to 14 months)
- Median Overall Survival (OS) at 2 years post radiation(Up to 26 months)
- Overall Proportion of patients with grade ≥ 3 adverse events (AEs)(Up to 5 months)
- Proportion of patients with acute grade ≥ 3 adverse events (AEs) by group(Up to 5 months)
- Proportion of patients with late onset grade ≥ 3 AEs by group post radiation(Up to 21 months)