CTRI/2015/09/006204尚未招募3 期
A randomized clinical trial evaluating the efficacy and safety of the addition of oral metronomic chemotherapy after completion of standard chemoradiation versus observation in carcinoma esophagus and gastro esophageal junction. -
Tata Memorial Center0 个研究点目标入组 300 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
- 300
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.Patients with histologic or cytologic diagnosis of squamous cell carcinoma of the esophagus or GEJ
- •2.Completed definitive radical CTRT, with at least 50 Gy of radiation within the preceding12 weeks, concurrently with one of the following chemotherapy regimens:
- •Paclitaxel 50mg/m2 and Carboplatin AUC 2 given weekly-at least 5 doses.
- •Cisplatin, at least 30mg/m2, given weekly-at least 5 doses.
- •5FU 750 to 1000 mg/m2 CIVI for 4-5 days and cisplatin 75 to 100mg/m2on day 1, given 3 weekly-at least 2 doses.
- •3.Age >=18 years
- •4.ECOG performance status PS 0-2
- •5.Adequate bone marrow function (hemoglobin > 8 g/L, platelets > 100 x 109/L, ANC > 1.5 x 109/L)
- •6.Adequate liver function (ALT/AST < 2 x ULN, serum bilirubin < 2 x ULN)
- •7.Adequate renal function (creatinine clearance > 45 ml/min)
- •8.Women of childbearing potential must be willing to consent to using effective contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter. A man who is the partner of a woman of childbearing potential must be willing to consent to using effective contraception (eg, vasectomy or barrier with spermicide) while on treatment and for 3 months thereafter.
- •9.Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals.
- •10.Signed, written informed consent.
排除标准
- •1.Clinical or radiologic evidence of metastatic disease.
- •2.Progressive disease at disease reassessment post CTRT.The presence of stable disease on restaging is permissible, however the patient should not have new sites of disease or an increase in disease (that qualifies for PD as per RECIST, or is determined to be PD by the radiologist or the investigator) as compared to the pre-CTRT scan.
- •3.QTc prolongation (QTc interval prolonged more than 0.5seconds)
- •4.Known hypersensitivity to methotrexate, celecoxib or sulfonamides.
- •5.Any significant active infection, including chronic active hepatitis B, active hepatitis C, HIV infection with AIDS or immunodeficiency syndromes.Testing for these is not mandatory unless clinically indicated. Participants with known hepatitis B/C infection will be allowed to participate, provided evidence of viral suppression has been documented and the patient remains on appropriate anti-viral therapy.
- •6.Serious uncontrolled medical illness (e.g. uncontrolled diabetes mellitus, uncontrolled hypertension, severe infection or untreated psychiatric conditions) that might limit the ability of the patient to comply with the protocol.
- •7.Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.
- •8.History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- •9.History of malignancy other than esophagogastric cancer, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or othermalignancies curatively treated with no evidence of disease for >5 years.
- •10.Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or willing to use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilized or be willing to use a (double if required) barrier method of contraception.
研究者
相似试验
招募中
3 期
Treatment of Alopecia AreataCTRI/2024/02/062980Dr Rakesh Tilak raj
尚未招募
2 期
Study to evaluate the efficacy and safety of chemotherapy & Radiation therapy vs observation following surgery in patients with esophageal cancerCTRI/2019/05/019335Tata Memorial Hospital
已完成
不适用
A randomized clinical study evaluating the efficacy and tolerance of a new, reduced-volume, bowel preparation for colonoscopy ; a comparison between two different regimensgeneral populationJPRN-UMIN000014766Department of Endoscopy,Aichi Cancer Center Hospital400
尚未招募
不适用
Randomized clinical trial assessing efficacy of a novel Moisturising Skin Support versus standard care for management of chronic woundsACTRN12622001229763Optiderma Biosciences Pty. Ltd528
已完成
4 期
A randomised clinical trial evaluating the effect of remifentanil vs fentanyl during cardiac surgery on the incidence of chronic thoracic pain.chronische thoracale pijnchronic thoracic painchronic pain on chestNL-OMON41643Sint Antonius Ziekenhuis126