| CTRI Number |
CTRI/2025/07/090646 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Using a Scoring Tool to Adjust Chemotherapy Doses for Fewer Side Effects in Cancer Patients |
|
Scientific Title of Study
|
Risk stratified SPA score versus Physician decision chemotherapy
dosage in patients with palliative chemotherapy to reduce treatment
Toxicity- Open label, Randomised Controlled Trial
|
| Trial Acronym |
SPART |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Biswajit Dubashi |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Medical Oncology, Regional Cancer Centre, Dhanvantri Nagar, Jipmer
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8056338405 |
| Fax |
|
| Email |
drbiswajitdm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajat Soge |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Medical Oncology, Regional Cancer Centre, Dhanvantri Nagar, Jipmer
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8421138792 |
| Fax |
|
| Email |
rpsoge@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Soge |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Medical Oncology, Regional Cancer Centre, Dhanvantri Nagar, Jipmer
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8421138792 |
| Fax |
|
| Email |
rpsoge@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
JIPMER Campus Road,JIPMER Campus,Puducherry,605006 |
| 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 |
| Dr Rajat Soge |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Room Number: 18 Regional Cancer Centre Department of Medical Oncology JIPMER JIPMER Campus Road, JIPMER Campus Puducherry 605006
Pondicherry
PONDICHERRY |
8421138792
rpsoge@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physician’s Choice of Chemotherapy Dose |
Standard chemotherapy at a dose and schedule determined by the treating oncologist, based on clinical judgment and routine clinical parameters and olanzapine |
| Intervention |
SPA score |
SPA risk score-based chemotherapy dose adjustment along with Olanzapine
Patients will be assigned a risk score based on the following parameters:
Subjective Global Assessment (SGA): A, B, or C
ECOG Performance Status (PS): 0, 1, or more than or equal to 2
Serum Albumin: more than or equal to 3.6 g/dL, 3.0–3.5 g/dL, or less than 3.0 g/dL
Based on these criteria, patients will be categorized in each group and dosed as follows:
Low Risk: Chemotherapy at 100% standard dose
Intermediate Risk: Chemotherapy at 80% of standard dose
High Risk: Chemotherapy at 60% of standard dose
These patients will also receive olanzapine 2.5 mg once daily orally for 12 weeks, starting from Day 1 of chemotherapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Histologically confirmed cancer (lung, gastroesophageal, pancreaticobiliary (PB)) cancers
2. Locally advanced inoperable and metastatic cancer patients not suitable for curative therapy and planned for first-line palliative chemotherapy
3. Patients who have previously received adjuvant/neoadjuvant chemotherapy can be included in the study if they have received chemotherapy more than 6 months before randomization
4. No major surgery within the last 4 weeks, excepting palliative surgeries like colostomy, GJ, biliary drainage, etc.
5. Haematological, hepatic, and renal function parameters satisfying the parameters mentioned below -
a. Haematological- Hb more than 80 g/L, ANC more than or equal to 1.5 x 10 raised to 9/L, platelets more than or equal to 100 x 10 raised to 9/L.
b. Liver function- bilirubin less than or equal to 2 x upper limit normal (ULN), AST/ALT less than or equal to 5 times ULN
c. Renal function- Creatinine clearance more than or equal to 40 mL/min
d. Baseline ECG/2D Echocardiography LVEF more than or equal to 50%
|
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity or contraindication to chemotherapy drugs used in the study
2. Do not give consent for the study
3. Pregnancy or lactation
4. Patient planned for targeted therapy alone
5. Symptomatic, untreated brain metastasis
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Grade more than or equal to 2 non-haematological and Grade more than or equal to 3 haematological chemotherapy-related toxicity by NCI CTCAE v5.0 |
Assessed before each cycle and at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cumulative frequency of haematological Grade more than or equal to 3 and non-haematological Grade more than or equal to 2 chemotherapy-related toxicity |
Assessed before each cycle and at 12 weeks |
| Disease response rates by RECIST 1.1 criteria |
12 weeks |
| Dose intensity, delays and modifications |
Assessed before each cycle and at 12 weeks |
| Chemotherapy discontinuation rates |
12 weeks |
| Progression-free survival |
1 year |
| Overall survival |
1 year |
| Change in quality of life by Cancer Institute-Quality of Life Questionnaire |
Assessed before each cycle and at 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="206"
Sample Size from India="206"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single-centre academic study to be conducted at JIPMER. Enrollment will start in July Project title: Risk stratified SPA score versus Physician decision chemotherapy dosage in patients with palliative chemotherapy to reduce treatment toxicity- Open label, Randomised controlled Trial (SPART)
Aim: To compare the SPA score categorised tailoring of chemotherapy dose versus physicians’ decision, both combined with olanzapine, to reduce treatment toxicity and improve survival
Research question: Does SPA score-categorised dose tailoring of chemotherapy versus physicians’ decision, both combined with olanzapine, reduce the incidence of grade 2 or higher toxicity during 12 weeks of chemotherapy in patients receiving palliative chemotherapy in Lung, Gastroesophageal and Pancreaticobiliary malignancy?
Primary objective: To compare the incidence of grade more than or equal to 2 non-haematological and grade grade more than or equal to 3 haematological chemotherapy-related toxicity during 12 weeks of chemotherapy based on NCI CTCAE v5.0 among patients receiving SPA score-categorised tailoring of chemotherapy dose versus physicians’ decision, combined with olanzapine in patients receiving palliative chemotherapy in Lung, Gastroesophageal and Pancreaticobiliary malignancy.
Secondary objectives: To compare the 2 groups for 1. Cumulative frequency of haematological Grade more than or equal to 3 and non-haematological Grade more than or equal to 2 chemotherapy-related toxicity during the 12 weeks of chemotherapy 2. Response rates by RECIST 1.1 criteria 3. Dose intensity, delays and modifications 4. Chemotherapy discontinuation rates 5. Progression-free survival at 1 year 6. Overall survival at 1 year 7. Quality of life measured by the Cancer Institute-Quality of Life Questionnaire
Methodology:
Patients planned for palliative chemotherapy will be screened. Patients fulfilling the inclusion and exclusion criteria are included in the study. Patients will be randomised into two arms
Arm A (Intervention): Chemotherapy dose adjustments based on the SPA risk score + Olanzapine Arm B (Control Group): Physician’s choice of chemotherapy dose + Olanzapine The highest score will be determined by selecting the value among the three variables
•Low Risk: All parameters within the low-risk column (100% dose of chemotherapy) •Intermediate Risk: Any one or more parameter not fulfilling the low-risk columns would be considered intermediate risk (80% dose of chemotherapy) •High Risk: Any one parameter within the high-risk column (60% dose of chemotherapy)
Arm B will receive the physician’s decision of the chemotherapy dose along with the tablet Olanzapine 2.5 mg once daily up to 12 weeks
Baseline SGA score, PS, serum albumin, and CI-QoL II questionnaire will be recorded. Before each chemotherapy cycle and at 12 weeks, toxicity grading by CTCAE version 5.0 and CI-QoL II questionnaire will be done
sample size: 206 patients, 103 in each arm
Intention to treat: All patients who are randomised and initiated on treatment with chemotherapy with olanzapine, based on groups, will be analysed. If not started on treatment will be replaced.
In patients for whom toxicity assessment is not available at 12 weeks, they will be analysed in two ways 1. They will be considered to have a negative outcome 2. They will be counted as an event
|