Quality of Life After Primary Transoral Robotic Surgery vs Intensity-modulated Radiotherapy for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma: A Randomized National Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 138
- 试验地点
- 3
- 主要终点
- Swallowing related quality of life by MDADI
研究概览
简要总结
Oropharyngeal squamous cell carcinoma (OPSCC) is now the most frequently diagnosed head and neck cancer in Denmark which is mainly due to the increase of Human Papillomavirus (HPV). Patients with HPV-positive OPSCC have a significantly higher survival rate compared to HPV-negative OPSCC. The traditional primary treatment modality in Denmark is Intensity Modulated Radiation Therapy (IMRT), and in advanced stages in combination with chemotherapy. Since 2009, Transoral Robotic Surgery (TORS) has enabled surgeons to perform minimally invasive surgery as an alternative to standard radiotherapy treatment which is considered the primary treatment for OPSCC in many countries. There is a lack of randomised trials comparing long-term functional outcomes after TORS or IMRT. Current data are mostly derived from retrospective studies with selection bias. However, several small retrospective studies have shown promising results when comparing the two treatment modalities in favour of TORS with regards to treatment related swallowing function and quality of life (QoL) without compromising survival outcomes.
This study aims to evaluate the early and long-term functional outcomes following two treatment arms 1) TORS combined with neck dissection and 2) IMRT±concurrent chemotherapy with a special focus on swallowing-related QoL.
详细描述
The current study is performed as a nationwide randomized phase III study that aims to investigate the long-term functional outcomes after primary TORS and neck dissection vs. IMRT±concurrent chemotherapy for early-stage oropharyngeal squamous cell carcinoma.
The study is a registered Danish Head and Neck Cancer Group (DAHANCA) 34 protocol.
The investigators hypothesise that primary TORS±adjuvant therapy will significantly improve the QoL at 12 months follow-up compared to IMRT±concurrent chemotherapy.
Primary endpoint: QoL measured by a composite MD Anderson Dysphagia Inventory (MDADI) score evaluated at 12 months follow-up after treatment (10-point difference)
Study design:
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
- 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
- •18 years or older
- •Able to provide informed consent
- •The Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2
- •Histologically confirmed oropharyngeal squamous cell carcinoma (exclusively palatine tonsils and base of tongue tumours) with known p16 status
- •Clinical tumour stage cT1-2 according to The Union for International Cancer Control (UICC), tumor (T), nodes (N), and metastases (M), (TNM) classification, 8th edition.
- •Clinical nodal stage cN0-1 according to UICC, TNM classification, 8th edition, however in p16 positive patients with unilateral metastasis, only a nodal metastasis up to a maximum of 4 cm in greatest diameter according to pre-operative imaging will be included.
- •Diagnostic imaging including computed tomography/magnetic resonance imaging (CT/MRI) performed within 14 days at time of randomization.
- •A tumour that is considered resectable according to MRI, clinical examination and/or ultrasound
排除标准
- •Serious medical comorbidities or ECOG/WHO performance status >
- •Other contraindications to radiotherapy, chemotherapy or surgery
- •Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
- •Distant metastasis
- •Clinically and radiologic signs of nodal extracapsular extension
- •Previous radiotherapy of the head and neck
- •Previous head and neck cancer
- •Significant trismus (maximum inter-incisal opening ≤ 35mm) [46]
- •Unable or unwilling to complete quality of life questionnaires
- •Posterior pharyngeal wall involvement
研究组 & 干预措施
Transoral robotic surgery (TORS)
干预措施: Transoral Robotic Surgery (TORS) with neck dissection (Procedure)
Intensity-Modulated Radiation Therapy (IMRT)
Patients with clinical T1N0 stage are offered accelerated radiotherapy to 66 Gy/33fractions with concurrent nimorazole.
Patients with clinical T2N0 stage are offered either accelerated radiotherapy to 66 Gy/33fractions with the option of weekly cisplatin to fit patients or hyper-fractionated accelerated radiotherapy to 76 Gy/56fractions both with concurrent nimorazole.
Patients with clinical T1-T2, N1 stage are offered accelerated radiotherapy to 66 Gy/33 fractions and nimorazole with the addition of concurrent weekly cisplatin 40 mg/sqm to fit patients.
干预措施: Intensity-Modulated Radiation Therapy (IMRT) (Radiation)
Intensity-Modulated Radiation Therapy (IMRT)
Patients with clinical T1N0 stage are offered accelerated radiotherapy to 66 Gy/33fractions with concurrent nimorazole.
Patients with clinical T2N0 stage are offered either accelerated radiotherapy to 66 Gy/33fractions with the option of weekly cisplatin to fit patients or hyper-fractionated accelerated radiotherapy to 76 Gy/56fractions both with concurrent nimorazole.
Patients with clinical T1-T2, N1 stage are offered accelerated radiotherapy to 66 Gy/33 fractions and nimorazole with the addition of concurrent weekly cisplatin 40 mg/sqm to fit patients.
干预措施: Cisplatin (Drug)
Intensity-Modulated Radiation Therapy (IMRT)
Patients with clinical T1N0 stage are offered accelerated radiotherapy to 66 Gy/33fractions with concurrent nimorazole.
Patients with clinical T2N0 stage are offered either accelerated radiotherapy to 66 Gy/33fractions with the option of weekly cisplatin to fit patients or hyper-fractionated accelerated radiotherapy to 76 Gy/56fractions both with concurrent nimorazole.
Patients with clinical T1-T2, N1 stage are offered accelerated radiotherapy to 66 Gy/33 fractions and nimorazole with the addition of concurrent weekly cisplatin 40 mg/sqm to fit patients.
干预措施: Nimorazole. (Drug)
结局指标
主要结局
Swallowing related quality of life by MDADI
时间窗: evaluated at baseline, 3 and 12 months after treatment
Difference in swallowing related quality of life measured by a composite MD Anderson Dysphagia Inventory (MDADI) score. The MDADI is a 20-item self-administered questionnaire that quantifies swallowing-related quality of life. Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. Summary and subscale MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).
次要结局
- Nerve function(evaluated at baseline and up to 12 months after treatment)
- Late toxicity(evaluated at 3, 6, 12, 24, 36, 48 and 60 months after treatment)
- Overall survival(evaluated from time of randomization up to 5 years)
- Nasogastric or percutaneus tube dependency(evaluated at baseline, 3 and 12 months after treatment)
- Patient reported quality of life by EORTC-QLQ-H&N35(evaluated at baseline, 3 and 12 months after treatment)
- Treatment-related pain(evaluated at baseline up to 12 months after treatment)
- Swallowing function by fiberendoscopic evaluation(evaluated at baseline, 3 and 12 months after treatment)
- Patients returning to work after treatment(evaluated at baseline, 3 and 12 months after treatment)
- Swallowing function by modified barium swallowing(evaluated at baseline, 3 and 12 months after treatment)
- Patient reported quality of life by EORTC QLQ-C30(evaluated at baseline, 3 and 12 months after treatment)
- Weight(evaluated at baseline, 3 and 12 months after treatment)
- Morbidity after staging neck after staging neck dissection(evaluated from time of neck dissection up to 14 days after treatment)
- Disease-free survival(evaluated from time of randomization up to 5 years)
- Disease-specific survival(evaluated from time of randomization up to 5 years)
- Distant recurrence(evaluated from time of randomization up to 5 years)
- Loco-regional recurrence(evaluated from time of randomization up to 5 years)
研究者
Christian von Buchwald
Clinical Professor and Study Chair
Rigshospitalet, Denmark