SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer: A Phase II Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- UNICANCER
- 入组人数
- 128
- 试验地点
- 23
- 主要终点
- Two-years Disease Free Survival (DFS) rate
研究概览
简要总结
Oropharyngeal cancer (OPC) is the most common type of head and neck cancer. The current standard treatment for this cancer is radiotherapy (RT) of the tumour and lymph nodes of both sides of the neck, combined with concurrent chemotherapy for advanced stages. Even though a small proportion of patients with this cancer have involvement of the lymph nodes of the neck on the opposite side of the tumour (contralateral involvement) or involvement of the lymph nodes on both sides of the neck (bilateral involvement), bilateral radiotherapy is performed due to the risk of contralateral microscopic involvement, which is invisible on imaging and clinical examination. Bilateral radiotherapy causes more adverse events, leading to a decrease in quality of life.
Lymphatic mapping using Single Photon Emission Computed Tomography-Computed Tomography (SPECT-CT) imaging is a technique that visualises the lymphatic drainage of the tumour and thus determines whether radiotherapy should be delivered unilaterally or bilaterally to the lymph nodes. This technique would therefore reduce adverse events and improve quality of life, while maintaining the efficacy of radiotherapy.
The goal of the clinical trial SELECT-FR is to investigate if the efficacy of a lymphatic drainage mapping with a SPECT-CT-guided approach is acceptable in terms of two-year Disease Free Survival (DFS) rate in patients with lateralized OPC.
详细描述
SELECT-FR is a national, randomized, phase II, non-comparative trial.
Patients aged 18 or over, with lateralized oropharyngeal squamous cell carcinoma (tonsil, soft palate, pharyngeal wall or tongue base) not involving or crossing midline, Human Papilloma Virus (HPV) positive or negative, T1-T3 with no contralateral nodes or nodes > 6 cm on Computed Tomography (CT), Magnetic Resonance Imaging (MRI) or Positron Emission Tomography-Computed Tomography (PET-CT).
Eligible subjects will be randomized at a 1:1 ratio into the experimental and control arms.
- Experimental arm: Patients will receive definitive RT to the primary tumour and ipsilateral neck nodes, while contralateral neck RT treatment will be guided by lymphatic mapping with SPECT-CT.
- Control arm: Patients will receive definitive RT to the primary tumour and bilateral neck nodes (Note: candidates for standard unilateral neck RT are not eligible).
Randomization will be stratified by the following factors:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Patients must have signed a written informed consent form prior to any trial specific procedures.
- •Patients with histologically confirmed T1-T3 M0 lateralized OPC (tonsil, soft palate, pharyngeal wall or base of tongue) not involving or crossing midline. Nodal disease may include no node or single or multiple ipsilateral lymph nodes (largest should be equal or less than 6 cm in maximum diameter) without contralateral nodes involved. For HPV-positive patients, this includes N0-N
- •For HPV-negative patients, this includes N0-N2b. Patients with radiologic extranodal extension without clinical signs of extranodal extension (skin invasion, deep nodal fixation, and/or clinical signs of cranial nerve or brachial plexus invasion) will be eligible for participation.
- •HPV-positive or -negative (by p16 immunohistochemistry). Tumours will be classified as p16 at local sites based on greater than 70% strong diffuse nuclear or nuclear and cytoplasmic staining.
- •Planned definitive bilateral neck radiotherapy with or without concurrent chemotherapy.
- •Patients ≥ 18 years old.
- •ECOG Performance Status 0-
- •The following radiological investigations must have been done within 8 weeks before randomization:
- •CT or MRI of the neck (with head imaging as indicated);
- •PET-CT scan;
- •Chest CT scan.
- •Patients who receive a concomitant chemoradiotherapy (cCRT) should have adequate organ and bone marrow function including the following:
- •Hematological function (absolute neutrophil count ≥ 1.5 x10⁹/L, platelets ≥ 100 x10⁹/L, hemoglobin ≥ 9 g/dL) measured before cCRT.
- •Renal function (creatinine clearance ≥ 50 mL/min per Cockcroft and Gault formula) measured before cCRT.
- •Hepatic function (total bilirubin < 1.5 ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2.5 ULN, Alkaline phosphatase < 2.5 ULN) measured before cCRT.
- •Women/men of childbearing potential must have agreed to use a highly effective contraceptive method up to 90 days after completing radiotherapy.
- •Women of childbearing potential must have a negative pregnancy test before the beginning of the trial.
- •Treating surgeon must confirm that the patient is a candidate to undergo injection procedure for lymphatic mapping in either the nuclear medicine, ambulatory clinic, or operating room setting.
- •Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
- •Patients affiliated to (or beneficiary from) the French social security system.
- •Patients 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.
排除标准
- •Patients with T1-T2 cancers isolated to the tonsil fossa (i.e., without any soft palate, tongue base, posterior pharyngeal wall or posterior tonsil pillar involvement) with no involved lymph nodes or with a single ipsilateral node < 3 cm without extranodal extension.
- •Patients with tonsil or tongue base primary squamous cell carcinoma who have previously undergone diagnostic palatine or lingual tonsillectomy with either complete excision or with no clinically apparent residual disease are excluded. However, patients who have had previous deep biopsies or partial excisions with clinically evaluable disease are still eligible.
- •Previous head and neck cancer or multiple synchronous primary head and neck cancers.
- •Previous induction or neo-adjuvant chemotherapy.
- •Previous radiation therapy to the head and neck or comprehensive neck dissection of at least 3 levels on either side (due to potential for disrupted lymphatic channels and drainage pathways). Patients who have had excisional biopsies of involved lymph nodes are, however, still eligible.
- •Previous radiotracer allergy. Contraindication in patients with history of hypersensitivity to human albumin-containing products.
- •Patients with severe, active co-morbidity including any of the following:
- •Chronic Obstructive Pulmonary Disease or other pulmonary illness requiring hospitalization within 30 days of registration.
- •Unstable angina and/or congestive heart failure requiring hospitalization within the 30 days of registration.
- •Acute myocardial infarction within 30 days of study registration.
- •Diseases precluding RT (e.g., scleroderma).
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, as assessed by the investigator.
- •Pregnant or breastfeeding women.
- •Patient enrolled in another therapeutic trial within 30 days of registration.
- •Persons deprived of their liberty or under protective custody or guardianship.
研究组 & 干预措施
Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy
Radiotherapy of ipsilateral neck nodes & Radiotherapy of the contralateral neck nodes guided by SPECT-CT
干预措施: Lymphatic mapping with SPECT-CT (Other)
Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy
Radiotherapy of ipsilateral neck nodes & Radiotherapy of the contralateral neck nodes guided by SPECT-CT
干预措施: Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy (Radiation)
Bilateral neck radiotherapy
Radiotherapy of nodes on both sides of the neck
干预措施: Bilateral neck radiotherapy (Radiation)
结局指标
主要结局
Two-years Disease Free Survival (DFS) rate
时间窗: At 2 years after treatment
The primary endpoint is 2 year-Disease-Free Survival rate (2y-DFS) defined as patients free of disease at two years. Patients without any event before 2 years will be considered as success, patients lost to follow-up before 2 years will be considered as failure.
次要结局
- Disease free survival(From randomization to any of the following events: local, regional, or distant recurrence or death from any cause, up to 3 years after treatment.)
- Overall survival (OS)(From randomization to the date of death from any cause, up to 3 years after treatment.)
- Isolated Contralateral Neck Failure (iCNF)(From randomization to the date of iCNF, up to 3 years after treatment.)
- Local-regional failure (LRF)(From randomization to the date of any local or regional failure, up to 3 years after treatment.)
- Distant metastases (DM)(From randomization until clear evidence of distant metastasis, up to 3 years after treatment.)
- Disease free survival(From randomization to any of the following events: local, regional, or distant recurrence or death from any cause, up to 3 years after treatment.)
- Overall survival (OS)(From randomization to the date of death from any cause, up to 3 years after treatment.)
- Isolated Contralateral Neck Failure (iCNF)(From randomization to the date of iCNF, up to 3 years after treatment.)
- Local-regional failure (LRF)(From randomization to the date of any local or regional failure, up to 3 years after treatment.)
- Distant metastases (DM)(From randomization until clear evidence of distant metastasis, up to 3 years after treatment.)
- Incidence and Severity of Treatment-Related Adverse Events(Throughout study completion, up to 3 years after treatment.)
- Incidence and Severity of Treatment-Related Adverse Events reported by patients (using items of PRO-CTCAE)(Throughout study completion, up to 2 years after treatment.)
- Gastrostomy tube usage(Throughout study completion, up to 3 years after treatment.)