Health Condition 1: null- Patients with Intermediate -high grade glioma ( WHO grade 2- 4 gliomas undergoing adjuvant temozolomide therapy
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants must be post radical chemoradiation for a histologically confirmed newly diagnosed grade II-IV Glioma. 2.Participants must warrant adjuvant temozolomide 3.Age : Any age above 18 years. No maximum age. 4.Post first 2 cycles of adjuvant temozolomide 5.ECOG performance status 6.Feasibility of doing video call at native place. Either internet based video call service or a smartphone based video call service. For internet based service either presence of skype or any other equivalent service for video call. For smartphone based video call presence of either a 3G or 4G service. For internet based video call presence of a webcam based camera of 480 pixels or more. For smartphone based video call presence of a front facing camera of 1.3 megapixels or more. 7.Participants must have normal organ and marrow function as defined below: a.Leukocytes >=2,500/mcL or ANC >= 1000 b.Platelets >=100,000/mcL c.Total bilirubin d.AST(SGOT)/ALT(SGPT) e.Calculated Creatinine clearance > 30 ml/min 8.The effect of temozolomide chemotherapy on the developing human fetus are teratogenic. Hence women and men of reproductive age 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. . 9.Both men and women of all races and ethnic groups are eligible for this trial. 10.Willing and able to comply with all study requirements, including treatment (able to swallow tablets), able to be followed up at regular intervals and/or nature of required assessments (e.g. ability to undergo video follow up) 11.Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
Exclusion criteria: 1.Participants who had life threatening complications either during CTRT with temozolomide or during first 2 cycles of temozolomide 2.Participants who are receiving any other investigational agents. 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, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents, 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. 5.Pregnant women and breastfeeding women are excluded from this study because temozolomide has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants. These potential risks may also apply to other agents used in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment plan for administration of temozolamide will be compared at the end of the study between the 2 approaches.Timepoint: 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Agreement between different domains of treatment plan between VF & CCF 2.To compare the patients satisfaction rate between VF & CCF 3.To compare the direct cost between VF & CCFTimepoint: 1.1 month 2.1 month 3.1 month | — |
Countries
India
Contacts
Public ContactDr Vijay Patil
Tata Memorial Hospital
Outcome results
None listed