Patient Reported Outcomes in Term of Swallowing and Quality of Life After Prophylactic Versus Reactive Percutaneous Endoscopic Gastrostomy Tube Placement in Advanced Oropharyngeal Cancer Patients Treated With Definitive Chemo-radiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- global M.D. Anderson Dysphagia Inventory score at 6 months after end of treatment.
研究概览
简要总结
Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer.
Study is composed by 2 arms of subjects: prophylactic or reactive percutaneous endoscopic gastrostomy tube placement.
All subjects will be treated with a cisplatin standard chemotherapy regimen and by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT).
详细描述
Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer.
Study is composed by 2 arms of subjects (male or female): prophylactic or reactive percutaneous endoscopic gastrostomy tube placement.
The arm will be allocated by randomisation (1:1).
- Prophylactic PEG (pPEG): Prophylactic PEG tube will be placed before the start of the study treatment (CRT). The enteral nutrition will start following the assessment by the clinical dietitian in order to complete the current oral consumption according to the estimated energy needs (on the basis of 30 to 35 kcal / kg adapted and 1.2 to 1.5 g / prot./ kg.BW) with an increase as needed during the treatment.
- Reactive PEG (rPEG): Reactive PEG tube will be placed and enteral nutrition initiated, during the study treatment period in case of decrease of oral intake less than 2/3 of estimated energy requirements (based on 30-35 kcal / adapted kg .BW and 1.2 - 1.5 g/prot./adapted kg. BW) for a period of or anticipated to be, greater than 7 days or weight loss ≥ 5% from pre-treatment baseline).
All subjects will be treated with a cisplatin standard chemotherapy regimen and by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age ≥ 18 years old
- •ECOG performance status ≤ 2
- •Female and Male
- •Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx
- •Candidate for curative intent radiotherapy and systemic treatment
- •No prior or current anticancer treatment for the HNSCC (e.g. neo-adjuvant chemotherapy, surgery)
- •Diagnosis biopsy results
- •HPV/p 16 testing results
- •Serum test (for subjects of childbearing potential) negative within 7 days prior to the 1st CRT administration.
- •Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least 6 months after the last administration of cisplatin.
- •Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the cisplatin.
- •Adequate bone marrow function as defined below:
- •Absolute neutrophil count (ANC) ≥1500/µL or 1.5x109/L
- •Hemoglobin ≥ 9 g/dL
- •Platelets ≥100000/µL or 100x109/L
- •Adequate liver function as defined below:
- •Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome < 3 x UNL is allowed
- •AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN
- •Alkaline phosphatase ≤ 2.5 x ULN
- •Adequate renal function as defined below:
- •Creatinine ≤ 1.5 x UNL and creatinine clearance > 60 mL/min
- •Peripheral neuropathy ≤ grade 1
- •Hear impaired ≤ grade 1
- •Completion of all necessary screening procedures within 15 days prior to randomisation.
- •Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- •Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by principal investigator upon screening
排除标准
- •Severe malnutrition
- •Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE_v.5)
- •Distant metastasis
- •Serious coagulation disorders (INR>1.5, PTT>50s, platelets <50000/mm3)
- •Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
- •Other malignancies in the 3 years prior to study entry except of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin;
- •Pregnant and/or lactating women.
- •Known hypersensitivity to the study drug (cisplatin) or excipients.
研究组 & 干预措施
Prophylactic PEG
Prophylactic PEG tube will be placed before the start of the study treatment (CRT). The enteral nutrition will start following the assessment by the clinical dietitian in order to complete the current oral consumption according to the estimated energy needs (on the basis of 30 to 35 kcal / kg adapted and 1.2 to 1.5 g / prot./ kg.BW) with an increase as needed during the treatment.
干预措施: Percutaneous Endoscopic Gastrotomy tube placement (Device)
Prophylactic PEG
Prophylactic PEG tube will be placed before the start of the study treatment (CRT). The enteral nutrition will start following the assessment by the clinical dietitian in order to complete the current oral consumption according to the estimated energy needs (on the basis of 30 to 35 kcal / kg adapted and 1.2 to 1.5 g / prot./ kg.BW) with an increase as needed during the treatment.
干预措施: Cisplatin injection (Drug)
Prophylactic PEG
Prophylactic PEG tube will be placed before the start of the study treatment (CRT). The enteral nutrition will start following the assessment by the clinical dietitian in order to complete the current oral consumption according to the estimated energy needs (on the basis of 30 to 35 kcal / kg adapted and 1.2 to 1.5 g / prot./ kg.BW) with an increase as needed during the treatment.
干预措施: Radiotherapy (Radiation)
Reactive PEG
Reactive PEG tube will be placed and enteral nutrition initiated, during the study treatment period in case of decrease of oral intake less than 2/3 of estimated energy requirements (based on 30-35 kcal / adapted kg .BW and 1.2 - 1.5 g/prot./adapted kg. BW) for a period of or anticipated to be, greater than 7 days or weight loss ≥ 5% from pre-treatment baseline).
干预措施: Percutaneous Endoscopic Gastrotomy tube placement (Device)
Reactive PEG
Reactive PEG tube will be placed and enteral nutrition initiated, during the study treatment period in case of decrease of oral intake less than 2/3 of estimated energy requirements (based on 30-35 kcal / adapted kg .BW and 1.2 - 1.5 g/prot./adapted kg. BW) for a period of or anticipated to be, greater than 7 days or weight loss ≥ 5% from pre-treatment baseline).
干预措施: Cisplatin injection (Drug)
Reactive PEG
Reactive PEG tube will be placed and enteral nutrition initiated, during the study treatment period in case of decrease of oral intake less than 2/3 of estimated energy requirements (based on 30-35 kcal / adapted kg .BW and 1.2 - 1.5 g/prot./adapted kg. BW) for a period of or anticipated to be, greater than 7 days or weight loss ≥ 5% from pre-treatment baseline).
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
global M.D. Anderson Dysphagia Inventory score at 6 months after end of treatment.
时间窗: at 6 months after end of treatment
The M.D.Anderson Dysphagia inventory is a dysphagia-specific quality-of-life questionnaire for patients with H\&N cancer including 20 items divided into 4 subscales emotional (6 questions), functional (5 questions), physical (8 questions) and one global question. Each subscale has a score ranging from 1 to 5 (higher scores represent a better outcome). The mean score of the 20 items will be multiplied by a factor of 20 to obtain a MDADI total score which ranges from 20 (extremely low functioning) to 100 (high functioning). A difference of 8 points in MDADI score is considered as the Minimal Clinically Important Difference for the trial.
次要结局
- Impact of tobacco consumption on the outcomes(Baseline, at week 3 and at 1, 3, 6, 12 and 24 months after the end of treatment.)
- Assessment of clinical tumour response after study treatment(at 3 and 12 months after end of treatment)
- Assessment of Quality of Life(Baseline; at week 3 & 6 during treatment; at 1,3, 6, 12 and 24 months after end of treatment)
- Assessment of chemo-radiotherapy treatment related toxicities and PEG tube placement complications(through study completion, an average of 38 months)
- Cost-Effectiveness of each treatment strategy(during the pre-study treatment period (within 15 days after randomisation and before starting study treatment) and at 12 months after end of treatment)
- Impact of the nutritional status on survival and toxicity outcomes(Baseline, during treatment period (7 weeks) and follow-up period (24 months))
- Assessment of the subject outcome(at 3, 12 and 36 months after end of treatment)
- Clinical validation of cancer prediction models available at www.predictcancer.org(at 6 months after treatment)
- Impact of HPV on the outcomes(at screening)