Study of induction chemotherapy in advance stage of cancer
- Conditions
- Health Condition 1: null- Oral cancers patients
- Registration Number
- CTRI/2017/04/008425
- Lead Sponsor
- TMC Research Administrative Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 1068
1.Participants must have malignancy arising from either buccal mucosa or oral tongue.
a.The tumors arising in gingivobuccal sulcus would be considered as buccal mucosa cancers in this study.
2.Clinical stage grouping Stage III or IV
3.The oral cancer should be deemed resectable
4.ECOG performance status <=2
5.Histopathologically or FNAC
7.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
8.The effects of chemotherapy on the developing human fetus are teratogenic. Hence women of childbearing potential and men must agree to use adequate contraception
1.Stage groups T3N0,T1N1, T2N1
2.Stage IVC
3.Patients receiving NACT for mandibular preservation or borderline resectable or technically unresectable status
4.Participants who are receiving any other investigational agents.
5.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. .
6.History of previous malignancy in last 5 years
7.Patients receiving methotrexate medical indications not limited to rheumatoid arthritis or as who have received it either as neoadjuvant or adjuvant within last 2 years.
8.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
9.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 4.02 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.
10.Pregnant women and breastfeeding women are excluded from this study because Neoadjuvant chemotherapy agents have the potential for teratogenic or abortifacient effects.
11.HIV-positive, Hepatitis B and C seropositive patients are excluded from this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method