CTRI/2021/03/031884尚未招募3 期
Phase III randomised controlled trial Comparing Alternative Regimens for escalating treatment of intermediate and high-risk oropharyngeal cancer-CompARE trial. - CompARE
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Oropharyngeal squamous cell carcinoma (OPSCC) in base of
- •tongue and tonsil (includes bilateral tumours) with a
- •Multidisciplinary Team (MDT) recommendation for treatment with
- •definitive concurrent chemoradiotherapy
- •2. All OPC T4 or N3 (HPV-pos and HPV-neg)
- •all HPV-neg OPC T1-T4, N1-N3 or T3-4, N0
- •HPV-pos OPC T1-T4 with N2b-N3 nodes AND who are smokers
- •>= 10 pack years current or previous smoking history
- •3. Minimum life expectancy of 3 months
- •4. Eastern Cooperative Oncology Group (ECOG) performance
- •status 0-1
- •5. Body weight of >30kg
- •6. Adequate renal function, estimated glomerular filtration rate
- •(eGFR) >50ml/min calculated using Cockcroft-Gault formula
- •7. Adequate bone marrow function (absolute neutrophil count (ANC)
- •>=1.5 x 109/L, haemoglobin >=9.0g/dL and platelets >=100 x 109/L)
- •8. Adequate liver function i.e. serum bilirubin <=1.5 times the upper
- •limit of normal (ULN), AST (SGOT)/ALT (SGPT) <=2.5 x
- •institutional upper limit of normal
- •9. Prothrombin time (PT) <=1.5 x ULN or International Normalised
- •Ratio (INR) <=1. 5
- •10.Magnesium >= lower limit of normal
- •11. No cancers in previous 5 years, except basal cell carcinoma of
- •skin and cervical intra-epithelial neoplasia (CIN)
- •12. Aged 18-70
- •13. Written informed consent given for the trial
- •14. Surgically resectable disease if being randomised to all four arms
- •15.Evidence of post-menopausal status or negative urinary or serum
- •pregnancy test for female pre-menopausal patients. Women will
- •be considered post-menopausal if they have been amenorrheic
- •for 12 months without an alternative medical cause. The following
- •age-specific requirements apply:
- •- Women <50 years of age would be considered postmenopausal
- •if they have been amenorrheic for 12 months
- •or more following cessation of exogenous hormonal
- •treatments and if they have luteinizing hormone and
- •follicle-stimulating hormone levels in the post-menopausal
- •range for the institution or underwent surgical sterilization
- •(bilateral oophorectomy or hysterectomy).
- •- Women >=50 years of age would be considered postmenopausal
- •if they have been amenorrheic for 12 months
- •or more following cessation of all exogenous hormonal
- •treatments, had radiation-induced menopause with last
- •menses >12 months ago, had chemotherapy-induced
- •menopause with last menses >12 months ago, or
- •underwent surgical sterilization (bilateral oophorectomy,
- •bilateral salpingectomy or hysterectomy).
- •16. Willingness to comply with the protocol for the duration of the
- •study, including undergoing treatment and scheduled visits and
- •examinations including follow up
排除标准
- •Entered in the Brief Summary section(last page of CTRI form ) due to repeated errors in accepting data in the Exclusion criteria section.
研究者
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