CTRI/2023/08/056693尚未招募3 期
Phase 3 study comparing TPF versus Paclitaxel-Carboplatin and oral metronomic chemotherapy as neoadjuvant chemotherapy for borderline resectable oral cancers - NI
TMC Research Administrative Council0 个研究点目标入组 0 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
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. Subjects must have borderline resectable oral cancer
- •2. Age: Male or female subjects aged = 18 years.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- •4. Subjects must have normal organ and marrow function as per institutional standards
- •5. Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last treatment administration if the risk of conception exists. The effects on the developing human fetus are teratogenic. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- •6. Both men and women of all races and ethnic groups are eligible for this study.
- •7. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and/or nature of required assessments.
- •8. Ability to understand and the willingness to sign a written informed consent document.
- •Subjects must have borderline resectable oral cancer
- •2. Age: Male or female subjects aged = 18 years.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- •4. Subjects must have normal organ and marrow function as per institutional standards
- •5. Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last treatment administration if the risk of conception exists. The effects on the developing human fetus are teratogenic. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- •6. Both men and women of all races and ethnic groups are eligible for this study.
- •7. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and/or nature of required assessments.
- •8. Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •1. Subjects who are receiving any other investigational agents.
- •2. Pregnant women are excluded from this study. Based on its mechanism of action, chemotherapy can cause fetal harm when administered to a pregnant woman. Therefore, potential risks of administering chemotherapy during pregnancy include increased rates of abortion or stillbirth. Advise females of reproductive potential to use effective contraception during treatment and for at least one month after the last dose.
- •3. Lactating females: Since many drugs are excreted in human milk, it is advised that a lactating woman should not breastfeed during treatment and for at least one month after the last dose due to the potential for serious adverse reactions in breastfed infants.
研究者
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