INRT- AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy Using Artificial Intelligence-Based Radiomics for Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Risk of Solitary Elective Volume Recurrence Following Elective Volume Reduction Using INRT
研究概览
简要总结
Elective nodal irradiation has been a longstanding standard-of-care in the management of mucosal squamous cell carcinoma of the head and neck. Recent studies have suggested that reduced elective dose and volume may be a viable approach to improve toxicity. In this study, we are eliminating the elective neck treatment, focusing therapy on involved and suspicious nodes.
详细描述
We recently completed and reported a successful study (INFIELD) using reduced elective dose (40 Gy) and volume (involved echelons + 1) for oropharynx and larynx cancer. In INRT-AIR (Involved Nodal Radiotherapy using AI-based Radiomics), we are eliminating the elective neck treatment altogether, using radiologic and radiomic-based criteria to focus treatment on the nodes themselves. Eligible patients include previously untreated patients with stage I-IVB oropharynx, larynx and hypopharynx cancer, excluding T1-2 glottic carcinoma. Patients requiring chemotherapy may receive cisplatin, cetuximab, or carboplatin-paclitexel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •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
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •7.1 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 or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- •Negative serum pregnancy test within 2 weeks before registration for women of childbearing potential.
- •Neck CT and/or neck MRI, and PET-CT (at least skull-to-thigh).
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Distant metastasis.
- •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, surgery may occur before or after treatment, provided all other eligibility criteria are met .
- •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.
- •Subjects 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 that, in the opinion of the investigator, would limit compliance with study requirements
- •Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- •History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.
研究组 & 干预措施
PET-CT at 3 months and ENT evaluation
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
干预措施: Intensity modulated radiation therapy (IMRT) (Radiation)
结局指标
主要结局
Risk of Solitary Elective Volume Recurrence Following Elective Volume Reduction Using INRT
时间窗: 2 years
Definition: solitary means that the recurrence occurred without a preceding or synchronous in-field or distant recurrence By definition, local recurrence (LR) means disease recurrence in the primary site, and regional recurrence (RR) is a nodal failure anywhere in the neck. Patients who experienced either an LR or RR (or both), were also coded as a locoregional recurrence.
次要结局
- Comparison of SEVR Risks by Anatomic Site(2 years)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales(Baseline, 3 months, 6 months, 12 months, 24 months)
- European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales(Baseline, 3 month, 6 month, 12 month, 24 months)
- MD Anderson Dysphagia Inventory (MDADI) Global, Emotional, Functional and Physical Subscales(Baseline, 3 months, 6 months, 12 months, 24 months)
- Skin Toxicity (Dermatitis)(2 years)
- Gastrostomy Placement(from end of treatment to 2 years post treatment)
- EQ-5D Quality of Life Overall Health Visual Analogue Scale (VAS)(Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months from the end of treatment)
- 2-year Overall and Progression-free Survival Following Treatment With INRT(2 years)
- Time From the End of Treatment for Disease-free Patients to Have Their Gastrostomy Tubes Removed(2 years)
研究者
David Sher
Professor
University of Texas Southwestern Medical Center