Comparision of two types of chemotherapy regimen in head and neck cancer
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2019/01/016837
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Head and neck cancers planned for palliative chemotherapy, post first line palliative chemotherapy failure
a.Patients who have failed within 6 months of curative treatment, where chemotherapy was a part will be considered.
2.Age : Any age >=18 years
3.ECOG performance status <=2
4.Histopathologically or FNAC (Fine needle aspiration cytology) proof of cancer.
5.Participants must have normal organ and marrow function as defined below:
a.Leukocytes >=3,000/mcL
b.Platelets >=100,000/mcL
c.Total bilirubin < 1.5 Ã? institutional upper limit of normal
d.AST(SGOT)/ALT(SGPT) <=2.5 Ã? institutional upper limit of normal
e.Calculated Creatinine clearance > 30 ml/min
6.The effects of chemotherapy on the developing human fetus are teratogenic. Hence women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 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. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of protocol.
7.Both men and women of all races and ethnic groups are eligible for this trial.
8.Willing and able to comply with all study requirements.
9.Ability to understand and the willingness to sign a written informed consent document
1.Participants who are currently receiving any other investigational agents.
2.Patients with QTc prolongation defined as QTc interval greater than 480 ms in view of risk of sudden cardiac death associated with use of ondansetron. Patients in whom an initial evaluation QTc is prolonged but with medical interventions it is restored to normal are eligible for the study. .
3.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
4.Uncontrolled intercurrent illness including, but not limited to, active tuberculosis, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents within last 1 year , inflammatory bowel disease, known hyperkalemia ( CTCAE version 5 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements. Patients who have uncontrolled hypertension or diabetes or other chronic medical condition at initial evaluation but in whom these conditions are controlled with medical intervention can be assessed for eligibility.
5.Pregnant women and breastfeeding women are excluded from this study because Chemotherapy agents have the potential for teratogenicity or abortifacient effects.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase II <br/ ><br>1.Disease control rate <br/ ><br>Phase III <br/ ><br>1.Over all survival <br/ ><br> <br/ ><br> <br/ ><br>Phase III <br/ ><br>1.Over all survival <br/ ><br>Timepoint: Phase II <br/ ><br>1.6 weeks <br/ ><br>Phase III <br/ ><br>1.6 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method Phase II <br/ ><br>1.Adverse Events <br/ ><br> <br/ ><br>Phase III <br/ ><br>1.Quality of life <br/ ><br>2.Adverese Event <br/ ><br>3.Progression free survivalTimepoint: Phase II <br/ ><br>1.6 Weeks <br/ ><br> <br/ ><br>Phase III <br/ ><br>1.6 months <br/ ><br>2.6 months <br/ ><br>3.6 months <br/ ><br>