Health Condition 1: C069- Malignant neoplasm of mouth, unspecified
Conditions
Interventions
Intervention1: TPF (Docetaxel, Cisplatin and 5FU): will be started with induction chemotherapy with TPF regimen after pretreatment investigation. 2-3 such cycles will be given after which response ass
Sponsors
TMC Research Administrative Council
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must have borderline resectable oral cancer 2. Age: Male or female subjects aged â?¥ 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 â?¥ 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the overall survival.Timepoint: OS will be assessed yearly post enrollment like Year 1,Year 2 etc till participant survives. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the progression free survivalTimepoint: Till last participants progressed;To compare the overall response rate post 2 cycles according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1Timepoint: At post 2 cycles of chemotherapy;To assess & compare the safety & tolerabilityTimepoint: During treatment & post treatment until death;QOL comparison between two armsTimepoint: At base line & at completion of NACT & then every 3 months or at each visit after completion of whole treatment for 2 years. | — |
Countries
India
Contacts
Public ContactDr Vanita Noronha
Tata Memorial Hospital
Outcome results
None listed