PRECEDENT: Pilot Phase II Study of Personalized Radiation to the Contralateral Neck Directed by Sentinel Node Evaluation in Lateralized Oral Cavity Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Contralateral regional control rate
研究概览
简要总结
This phase II trial studies how well personalized neck radiation therapy directed by sentinel lymph node biopsy (SLNB) works in treating patients with oral cavity squamous cell carcinoma (OCSCC). SLNB can be performed as part of standard care for OCSCC. During SLNB, a radiotracer is injected around the tumor. The lymph nodes are then biopsied and tested to see if the tracer injected into the tumor traveled to and is present in the sentinel lymph nodes (SLNs). Results of the SLNB are used to determine whether lymph nodes should be removed in both sides of the neck or just on the same side as the primary tumor. Standard treatment then involves radiation therapy to both sides of the neck, regardless of SLNB results. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Studies have shown only a small number of patients develop a return of the cancer (recurrence) in the opposite side of the neck after radiation therapy. In addition, radiation therapy can negatively impact patient outcomes like saliva production, speech and swallow function, increased risk of radiation induced cancers, and chronic pain. Standard of care SLNBs may be effective in determining whether radiation therapy only needs to be administered to one side of the neck or both sides. This may help spare tissue on the opposite side of the neck from receiving radiation if there is no indication of lymph node involvement there.
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
- •Patient must have biopsy-proven squamous cell carcinoma of the oral cavity
- •Clinical stage cT1-4a N0-2b M0 within 42 days of study enrollment based on the following work-up:
- •History and physical examination within 42 days of study enrollment; must include documentation of lateralized primary tumor site
- •Cross-sectional imaging of the head and neck within 42 days of study enrollment
- •Cross-sectional imaging of the chest within 42 days of study enrollment
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 within 42 days of study enrollment
- •Age > 18
- •Recommended treatment plan is surgical resection with ipsilateral neck dissection and SPECT-CT-guided sentinel node biopsy. Flap reconstruction is allowed
- •Patient is willing and able to provide informed consent. Patient provides study-specific informed consent prior to study entry
- •Women of childbearing potential and male participants must agree to use medically effect means of birth control throughout their participation in the treatment phase of the study
排除标准
- •Evidence of distant metastatic disease based on clinical or radiologic evaluation
- •Evidence of contralateral neck disease on staging imaging
- •Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years
- •Diagnosis of head and neck squamous cell carcinoma (SCC) in the oropharynx, nasopharynx, hypopharynx, and larynx
- •Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed. Prior immunotherapy for the study cancer is allowed.
- •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- •Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection
- •Pregnant and breast-feeding patients
- •Excisional biopsy for study cancer
- •Prior surgery involving the lateral neck, including neck dissection or gross injury to the neck that would preclude surgical dissection for this trial. Prior thyroid and central neck surgery is permissible; incisional biopsy is permitted
- •Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia [CLL]) or other active disease capable of causing lymphadenopathy (sarcoidosis or untreated mycobacterial infection)
- •Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy
- •Currently participating in another investigational therapeutic trial
研究组 & 干预措施
Treatment (SLN mapping, SLNB, RT, chemotherapy)
See Detailed Description.
干预措施: Modified Barium Swallow (Procedure)
Treatment (SLN mapping, SLNB, RT, chemotherapy)
See Detailed Description.
干预措施: Positron Emission Tomography (Procedure)
Treatment (SLN mapping, SLNB, RT, chemotherapy)
See Detailed Description.
干预措施: Questionnaire Administration (Other)
Treatment (SLN mapping, SLNB, RT, chemotherapy)
See Detailed Description.
干预措施: Radiation Therapy (Radiation)
Treatment (SLN mapping, SLNB, RT, chemotherapy)
See Detailed Description.
干预措施: Sentinel Lymph Node Biopsy (Procedure)
Treatment (SLN mapping, SLNB, RT, chemotherapy)
See Detailed Description.
干预措施: Single Photon Emission Computed Tomography (Procedure)
Treatment (SLN mapping, SLNB, RT, chemotherapy)
See Detailed Description.
干预措施: Technetium Tc 99m-labeled Tilmanocept (Radiation)
Treatment (SLN mapping, SLNB, RT, chemotherapy)
See Detailed Description.
干预措施: Paclitaxel (Drug)
Treatment (SLN mapping, SLNB, RT, chemotherapy)
See Detailed Description.
干预措施: Technetium Tc-99m Sulfur Colloid (Other)
Treatment (SLN mapping, SLNB, RT, chemotherapy)
See Detailed Description.
干预措施: Biospecimen Collection (Procedure)
Treatment (SLN mapping, SLNB, RT, chemotherapy)
See Detailed Description.
干预措施: Computed Tomography (Procedure)
Treatment (SLN mapping, SLNB, RT, chemotherapy)
See Detailed Description.
干预措施: Carboplatin (Drug)
Treatment (SLN mapping, SLNB, RT, chemotherapy)
See Detailed Description.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Contralateral regional control rate
时间窗: From completion of definitive treatment to neck recurrence date, death date or date of last contact, assessed at 1 year from completion of definitive treatment
Contralateral regional control rate is defined as the proportion of evaluable subjects free of contralateral neck recurrence at 1 year from completion of definitive treatment. Regional Recurrence is defined as biopsy-proven cancer within the ipsilateral or contralateral neck at any time point after initial surgical resection. When biopsy is not feasible, evidence of recurrence by imaging suffices only with documented attestation at tumor board that the imaging is clinically diagnostic of regional recurrence. Cumulative incidence function estimate with 90% confidence interval (CI) for follow-up after 1 year.
次要结局
- Change in neck function(Baseline up to 1 year from completion of definitive treatment)
- Change in oral and oropharyngeal dryness(Baseline up to 3 months from completion of definitive treatment)
- Change in quality of life(Baseline up to 3 months from completion of definitive treatment)
- Recurrence free survival(1 year from completion of definitive treatment)
- Overall survival(1 year from completion of definitive treatment)
- Disease-specific survival(1 year from completion of definitive treatment)