Health Condition 1: C109- Malignant neoplasm of oropharynx,unspecified
Conditions
Interventions
Intervention1: TPF regimen: Inj Docetaxel 75 mg/m2 in 500 ml NS intravenous over 1 hour on Day 1
Inj Cisplatin 75 mg/m2 in 500 ml NS over 1 hour on Day 1
Inj 5 FU 750 mg/m2 in 500 ml NS over 24 hours
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: 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.
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 |
|---|---|
| Overall SurvivalTimepoint: OS will be assessed as time in months from the date of randomization to the date of death. Patients alive at their last follow-ups will also be censored. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess and compare the safety and tolerabilityTimepoint: Adverse events will be assessed at each visit until 30 days after the last administration of study medication.;Overall Response Rate Timepoint: Response rate will be cumulative percentage of subjects having complete response and partial response as best response which will be assessed in accordance with RECIST version 1.1 criteria;Progression Free SurvivalTimepoint: From the date of randomisation to the date of progression | — |
Countries
India
Contacts
Public ContactDr Ashay Karpe
Cancer Research and Statistics Foundation
Outcome results
None listed