EUCTR2021-000999-11-ES进行中（未招募）1 期
A Phase 2b/3, multicenter, randomized, double-blind, placebocontrolled study comparing the efficacy and safety of clonidine mucoadhesive buccal tablet to placebo to prevent chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male/Female patients of = 18 years of age. Patients with histologically or pathologically confirmed squamous cell carcinoma of the oropharynx (including tonsils or the base of tongue) at one or several sites.
- •2. Patients treated with surgical resection of their primary tumor for localized or locally advanced disease T = T0 and/or N = N1 without distant metastasis (M0) (American Joint Committee on Cancer – AJCC 8th edition) and initiating adjuvant concurrent CRT within 8 weeks postoperatively.
- •Unknown primary with node-positive disease confirmed to be Squamous Cell Carcinoma would be allowed.
- •Patients who will be treated with definitive concurrent CRT for locally advanced disease T = T0 and/or N = N1 M0 (American Joint Committee on Cancer – AJCC 8th edition).
- •3. Patients eligible to receive a continuous course of external fractionated irradiation [conventional or intensity modulated radiation therapy (IMRT)] based on a daily dosing of 1.8 to 2.2 Gy/day 5 days/week in combination with cisplatin monotherapy either every 3 weeks (100 mg/m2) or weekly
- •cisplatin (40 mg/m2). Alternative treatment regimens are allowed only if cisplatin is contraindicated. The decision on which cisplatin regimen to use in combination with IMRT and study drug/placebo will be at the discretion of the investigator.
- •4. Radiation plan must include delivery of a cumulative dose of 60-72 Gy. The oropharynx should receive at least 50 Gy.
- •5. Patients with adequate laboratory values defined as:
- •a. Absolute neutrophil count = 1.5 × 109/L
- •b. Platelet count = 75 × 109/L
- •c. Hemoglobin = 9 g/dL
- •d. Creatinine blood level = 1.5 × upper limit of the normal range (ULN)
- •e. Total bilirubin = 1.5 × ULN; patients with Gilbert’s Syndrome can be included if hyperbilirubinemia = 3 × ULN
- •f. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 × ULN
- •6. Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. A performance status of 2 is allowed only if due to a patient’s malignancy.
- •7. Patients must provide written informed consent.
- •8. Human Papillomavirus (HPV) status documented by immunohistochemical detection of p16 expression in the tumor.
- •9. Negative serum pregnancy test for females of child-bearing potential at screening. A female is eligible to enter and participate in the study if she is of non-child-bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had a hysterectomy, a bilateral oophorectomy (ovariectomy), a bilateral tubal ligation, or is post-menopausal with a minimum of 1 year without menses.
- •10. Males with female partners of child-bearing potential and females of child-bearing potential must agree to use effective contraception starting prior to the first day of study drug treatment and continuing for 3 months after the last dose of study drug MBT.
- •11. Patients must be willing to complete questionnaires on a tablet, home computer, or paper form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1. Patients with no tumor or lesion in the oropharynx.
- •2. Prior induction chemotherapy for treatment of current malignancy.
- •3. Patients with planned accelerated IMRT.
- •4. Evidence of a concomitant other malignancy and/or any prior malignancy without complete remission in the last 2 years, except adequately treated basal or squamous cell carcinoma of the skin or in situ cervical cancer.
- •5. Patients with OM at baseline, any other oral ulceration or active oral infection (e.g., aphthous ulcers, orofacial herpes). Patients with post-operative pain of the mouth or throat are eligible.
- •6. Patients with known human immunodeficiency virus (HIV) seropositivity, known active Hepatitis B or C or known active tuberculosis.
- •7. Patients with systolic blood pressure (BP) < 100 mmHg and/or diastolic BP < 50 mmHg.
- •8. Patients with symptomatic cardiac dysrhythmia.
- •9. Patients with recent (less than 6 months) acute cardiovascular diseases (i.e., stroke, myocardial infarction).
- •10. Patients with any clinical condition, psychiatric condition, or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with study requirements and follow-up visits.
- •11. Patients currently being treated with sultopride, clonidine hydrochloride (eg, Catapres®), pentoxifylline or pilocarpine.
- •12. Patients intended to be treated specifically to prevent OM with any of the following:
- •a. Bioadherent agents and mouthwashes:
- •i. GelClair (consists of polyvinylpyrrolidone,
- •hyaluronic acid, and glycyrrhetinic acid)
- •ii. Sucralfate
- •iii. Episil mouth spray
- •iv. MuGard oral mucoadhesive
- •v. Saforis (L-glutamine (topical))
- •b. Drug therapies and biologics:
- •i. Amifostine (and similar free radical
- •scavenger/antioxidant medications)
- •ii. Palifermin (recombinant human keratinocyte
- •growth factor-(KGF-1))
- •iii. Glutamine
- •b. Interventional therapies
- •i. Low level laser therapy (LLLT)
- •13. Patients who are unable to tolerate oral diet and/or are feeding tube dependent at baseline.
- •14. Patients receiving an approved or an investigational anticancer agent other than those specified in this study.
- •15. Patients with a known hypersensitivity to clonidine or any of the MBT excipients.
- •16. Women who are pregnant or breast-feeding.
- •17. Patients whose medical, psychological or surgical conditions are unstable and may affect the study completion and/or compliance and/or the ability to give informed consent.
- •18. Men and women of child-bearing age and their respective partners unwilling to use a highly effective contraception method during the study and for 3 months after the last administration of study drug.
- •19. Patient who has participated in another clinical trial with an investigational drug in the last 30 days prior to randomization in the present clinical study.
- •20. Subjects with orthostatic hypotension, defined by a decrease of systolic BP and/or diastolic BP above 20 mmHg when the patient stands up.
- •21. Conditions including but not limited to COVID-19 which would confound the assessment of the effects and/or safety of study medication in the opinion of the investigator.
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