A study comparing two chemotherapy regimens prior to surgery for patients with technically unresectable oral cancers
- Conditions
- Health Condition 1: C109- Malignant neoplasm of oropharynx,unspecified
- Registration Number
- CTRI/2023/02/049406
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall SurvivalTimepoint: OS will be assessed as time in months from the <br/ ><br>date of randomization to the date of death. Patients <br/ ><br>alive at their last follow-ups will also be censored.
- Secondary Outcome Measures
Name Time Method Assess and compare the safety and tolerabilityTimepoint: Adverse events will be assessed at each visit until 30 days after the last administration of study <br/ ><br>medication.;Overall Response Rate <br/ ><br>Timepoint: Response rate will be cumulative percentage of subjects having <br/ ><br>complete response and partial response as best response which will be assessed <br/ ><br>in accordance with RECIST version 1.1 criteria;Progression Free SurvivalTimepoint: From the date of randomisation to the date of progression