| CTRI Number |
CTRI/2022/06/043215 [Registered on: 13/06/2022] Trial Registered Prospectively |
| Last Modified On: |
17/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study for comprehensive assessment of elderly cancer patients undergoing treatment for cancer |
|
Scientific Title of Study
|
Pilot study for comprehensive geriatric assessment of elderly cancer patients undergoing treatment at APCC-SENIOR STUDY |
| Trial Acronym |
SENIOR Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sapna Nangia |
| Designation |
Senior Consultant Radiation Oncologist |
| Affiliation |
Apollo Proton Cancer Centre |
| Address |
Breast Cancer Management Team, Dept of radiation oncology, (2nd floor),Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai
Chennai TAMIL NADU 600041 India |
| Phone |
9971866069 |
| Fax |
|
| Email |
sapna_nangia@outlook.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sapna Nangia |
| Designation |
Senior Consultant Radiation Oncologist |
| Affiliation |
Apollo Proton Cancer Centre |
| Address |
Breast Cancer Management Team, Dept of radiation oncology, (2nd floor),Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai
Chennai TAMIL NADU 600041 India |
| Phone |
9971866069 |
| Fax |
|
| Email |
sapna_nangia@outlook.com |
|
Details of Contact Person Public Query
|
| Name |
Sapna Nangia |
| Designation |
Senior Consultant Radiation Oncologist |
| Affiliation |
Apollo Proton Cancer Centre |
| Address |
Breast Cancer Management Team, Dept of radiation oncology, (2nd floor),Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai
Chennai TAMIL NADU 600041 India |
| Phone |
9971866069 |
| Fax |
|
| Email |
sapna_nangia@outlook.com |
|
|
Source of Monetary or Material Support
|
|
Not applicable as it is an academic collaborative observational study |
|
|
Primary Sponsor
|
| Name |
Apollo Proton Cancer Centre |
| Address |
Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai, Tamil Nadu |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sapna Nangia |
Apollo Proton Cancer Centre |
reast Cancer Management Team, Department of radiation oncology, (2nd floor), 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai, Tamil Nadu 600041 Chennai TAMIL NADU Chennai TAMIL NADU |
9971866069
sapna_nangia@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Biomedical Research, Apollo Hospitals, Apollo Hospitals Enterprise Limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Cancer patients aged ≥ 65 years reporting to APCC and being considered for treatment at APCC |
|
| ExclusionCriteria |
| Details |
1. Cancer patients on routine follow-up after completion of treatment
2. Patients not registered at APCC
3. Patients unable to fulfil the voluntary informed consent requirements |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Identification of vulnerable geriatric cancer patients using G8. |
1. Identification of vulnerable geriatric cancer patients using G8. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Demographic details, comorbidities and status as per G8 screening tool |
baseline, 3 months |
| Prospective record of geriatric assessment-based interventions in patients identified as vulnerable |
baseline, 3 months |
| Prospective record of treatment modifications at initiation due to elderly / G8 screening status of patient |
baseline, 3 months |
| Toxicity (Acute and late toxicity according to CTCAE version 5.0 criteria) |
baseline, 3 months |
| Quality of life EORCT QLQ-C30, QLQ-ELD14 at 0 and 3 months |
baseline, 3 months |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PROTOCOL SYNOPSIS Background and Rationale | The treatment of geriatric cancer patients has to be cognizant of their vulnerabilities. Oncologic interventions require to be tailor made to the chronological as well as biological age of patients as well as to their social situation. Geriatric assessment helps to identify areas of special concern as well as to design interventions to address them. There is limited information regarding vulnerabilities among the elderly cancer patient in India especially with reference to patients undergoing radiotherapy and surgery. This study aims to fill this gap. | General aim | Pilot study to record comprehensive evaluation of elderly patients before treatment decisions and to prospectively evaluate the association of G8 assessment with assessment-based intervention, clinical outcomes and treatment-related severe toxicity | Primary objective (endpoint) | · Identification of vulnerable geriatric cancer patients using G8. | Secondary objectives (endpoints) | · Demographic details, comorbidities and status as per G8 screening tool. · Prospective record of geriatric assessment-based interventions in patients identified as vulnerable. · Prospective record of treatment modifications at initiation due to elderly / G8 screening status of patient (0,3 months). · Treatment breaks/ reduced intensity/omission · Prolongation of treatment time · Hospital admission · ICU admission · Falls · Deterioration in G8 score · Toxicity (Acute and late toxicity according to CTCAE version 5.0 criteria at baseline and 3 months) · Quality of life EORTC QLQ-C30, QLQ-ELD14 at 0 and 3 months | Design | Prospective registry-based study | Population | All patients above 65 years registered at APCC for cancer diagnosis/treatment | Statistical considerations | Descriptive statistical analysis will be applied to routine demographic data collected, expressed as frequency for categorical variables. Chi-square test and Fisher’s exact test will be used for comparisons. Kaplan Meir curves will be used to summarize the time to event endpoints over time. Log-rank test will be used to test for differences in the OS for dichotomous variables. Factors significant in the univariate analysis will be tested by multivariate analysis using the Cox proportional hazard model. | |