CTRI/2017/04/008425尚未招募3 期
TRISUL : Randomized evaluation of TPF in Resectable oral cancers as Induction followed by Surgery in Locally advanced stage.
TMC Research Administrative Council0 个研究点目标入组 1,068 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,068
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.Participants must have malignancy arising from either buccal mucosa or oral tongue.
- •a.The tumors arising in gingivobuccal sulcus would be considered as buccal mucosa cancers in this study.
- •2.Clinical stage grouping Stage III or IV
- •3.The oral cancer should be deemed resectable
- •4.ECOG performance status <=2
- •5.Histopathologically or FNAC
- •7.Participants must have normal organ and marrow function as defined below
- •a.Leukocytes>=3,000/mcL
- •b.Platelets>=100,000/mcL
- •c.Total bilirubin < 1.5 Ã? institutional upper limit of normal
- •d.AST(SGOT)/ALT(SGPT)<=2.5 Ã? institutional upper limit of normal
- •e.Calculated Creatinine clearance > 30 ml/min
- •8.The effects of chemotherapy on the developing human fetus are teratogenic. Hence women of childbearing potential and men must agree to use adequate contraception
排除标准
- •1.Stage groups T3N0,T1N1, T2N1
- •2.Stage IVC
- •3.Patients receiving NACT for mandibular preservation or borderline resectable or technically unresectable status
- •4.Participants who are receiving any other investigational agents.
- •5.Patients with QTc prolongation defined as QTc interval greater than 480 ms in view of risk of sudden cardiac death associated with use of ondansetron. Patients in whom an initial evaluation QTc is prolonged but with medical interventions it is restored to normal are eligible for the study. .
- •6.History of previous malignancy in last 5 years
- •7.Patients receiving methotrexate medical indications not limited to rheumatoid arthritis or as who have received it either as neoadjuvant or adjuvant within last 2 years.
- •8.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
- •9.Uncontrolled intercurrent illness including, but not limited to, active tuberculosis, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents within last 1 year , inflammatory bowel disease, known hyperkalemia ( CTCAE version 4.02 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements. Patients who have uncontrolled hypertension or diabetes or other chronic medical condition at initial evaluation but in whom these conditions are controlled with medical intervention can be assessed for eligibility.
- •10.Pregnant women and breastfeeding women are excluded from this study because Neoadjuvant chemotherapy agents have the potential for teratogenic or abortifacient effects.
- •11.HIV-positive, Hepatitis B and C seropositive patients are excluded from this study
研究者
相似试验
进行中（未招募）
1 期
Randomised controlled open-label trial of TPF induction chemotherapy in the surgical management of locally advanced head and neck cancer(T = taxane, P = cisplatin, F = 5-fluorouracil) - TITAN - Version 6Head and Neck Squamous Cell Carcinoma, in any of the following sites:- Lip / Oral Cavity- Paranasal / Nasal- Larynx- Hypopharynx- Cervical Osephagus- Oropharynx (HPV - ve)MedDRA version: 14.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-023195-22-GBniversity of Liverpool7
已完成
2 期
Trial of Induction TPF therapy in Advanced head & Neck cancerCancerISRCTN74465582Aintree University Hospitals NHS Foundation Trust (UK)7
已完成
1 期
PriCoTTF Trial: A phase I/II trial of TTFields prior and concomitant to radiotherapy in newly diagnosed glioblastomaC71Malignant neoplasm of brainDRKS00016667niversitätsklinikum Essen33
尚未招募
4 期
Evaluation of bone formation after tooth extraction with T-PRF placement (Titanium platelet rich fibrin) at low and highspeeds.CTRI/2022/11/047406Thotimpuri Anuraga Tejaswi
暂停
4 期
Comparing blood products made in different test tubes in patients with bone lossCTRI/2020/03/023741Dr Mounika Reddy