AVOIDING ADJUVANT PROPHYLACTIC NECK IRRADIATION IN LATERALIZED ORAL CAVITY CANCER (APRON): A PHASE II Non-Inferiority study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Regional Recurrences. 2 years post-treatment: This will be defined as any nodal recurrence (isolated or in combination with local recurrence) occurring in ipsilateral or contralateral levels Ia - X nodal levels (as defined by Gregoire et al.).The regional recurrences will be diagnosed either radiologically or histologically or both
研究概览
简要总结
Cancers of the head and neck are one of the most common cancers in India, with approximately 2,50,000 new cases detected annually. Approximately 40% of these cancers are oral cavity cancers. Oral cavity cancers have a strong epidemiology from exposure to tobacco and alcohol.
The first step after detecting a doubtful lesion in the oral cavity is a clinical examination followed by a pathological and radiological examination. This is generally followed by surgery to remove the primary tumor and the draining lymph nodes.The pathologist examines post-surgery, the removed lesion, and high-risk features are determined on examination, and a report is made. Based on the final report, Patients are advised to undergo radiation radiotherapy (RT) or chemoradiotherapy (CTRT) to remove the microscopic disease and prevent recurrences.
Current standard practices mandate the RT to be given to the primary tumor site and the draining lymph nodes,i.e., almost the entire neck region. Due to the high amount of radiation being given to the structures of the neck,this is associated with increased risk side effects such as difficulty in swallowing, painful swallowing, and food going into the lungs. Many patients (approximately 30-40%) require long durations of assisted swallowing to manage these complications by utilizing external food pipes passed through either the nose or directly put in the bowel. This severely affects the quality of life of patients. Some studies report that to reduce these side effects in patients with an adequate number of lymph nodal tissue removed with surgery,RT can be avoided to the neck nodal region in those patients where the surgically removed neck nodes do not show involvement by the cancer (pN0/pN1).
In this study, patients with oral cavity cancers of the buccal mucosa and well-lateralized tongue who have been treated surgically for the primary site and have undergone adequate neck dissection with a minimum of 18 lymph nodes removed and are pN0/pN1 are included. After discussion in the multidisciplinary joint clinic, RT is indicated after surgery, we will treat only the region of the primary tumor and nearby neck nodal regions at maximum risk of relapse. We will omit RT to the neck nodal regions with lesser chances of relapse.
This study will help us determine if RT to the uninvolved low risk nodal region is required after adequate surgery. This will also help us to know if sparing of these low-risk neck nodal regions is associated with a better side effect profile for these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Buccal mucosa cancers Bucco-alveolar region.
- •Biopsy proven SCC and Any stage pT1-pT4a, pN0/N1 and has undergone adequate margin negative surgery as per institutional protocol.
- •Adequate node dissection of 18 nodes and tumor not crossing the midline.
- •Willing to sign ICF Tongue tumors Well lateralized tumors of the tongue 1-1.5cms from the midline or Tip of tongue involvement on baseline.
- •Biopsy-proven SCC.
- •Any T Stage pT1-pT4a.
- •pN0/N1(except Ia).
- •Has undergone upfront adequate margin negative surgery (as per institutional protocol).
- •Minimum of 18 nodes dissected.
- •No Contralateral node dissection.
- •Willing to sign Informed Consent form (ICF).
- •Age more than 18 years.
排除标准
- •Exclusion Criteria a) Synchronous /Metachronous tumours b) Unlikely to complete full course RT or follow up visits c) Patients with more than three risk factors such as i.
- •Worst pattern of invasion 5 iii.
- •Lymphovascular invasion iv.
- •Perineural invasion d) Previous history of head and neck cancer treated with surgery other than biopsy /FNAC e) Previous history of RT f) No more than 3 comorbidities like diabetes mellitus, hypertension, dyslipidaemia, comorbidities relating to heart such as IHD g) Pregnant nursing mother h) People unable to give consent.
结局指标
主要结局
Regional Recurrences. 2 years post-treatment: This will be defined as any nodal recurrence (isolated or in combination with local recurrence) occurring in ipsilateral or contralateral levels Ia - X nodal levels (as defined by Gregoire et al.).The regional recurrences will be diagnosed either radiologically or histologically or both
时间窗: Subjects fulfilling the criteria of inclusion /exclusion, having provided with consent form will be eligible for participation. Duration of enrolment will be for 36 months. Total duration of study will be of 5 years with follow up.
次要结局
- Swallowing function will be assessed using the MDADI scoring system. Local recurrence rate. Regional recurrence rate. Locoregional recurrence rate. Disease free survival. Overall survival rate. Toxicity assessment. Salvage rates of recurrence (surgery/ RT / Systmic therapy).MD Anderson lymphedema scoring system(Follow up will be done every 3 months post treatment, with appropriate, investigational techniques & QOL sheets for the first one year & then every 6 months for the second year. Pt will still be called for regular follow ups post 2 years of follow up.)
研究者
Dr Shwetabh Sinha
TATA MEMORIAL HOSPITAL