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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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