| CTRI Number |
CTRI/2026/04/109506 [Registered on: 27/04/2026] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Short versus standard radiation treatment before surgery in patients with soft tissue cancer of the arms and legs: a study comparing treatment results and side effects |
|
Scientific Title of Study
|
HypofracTionated Radiotherapy In Soft Tissue Sarcomas of Extremities and Limb Girdles – A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jifmi Jose Manjali |
| Designation |
Associate Professor Radiation Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Main Building Ground Floor OPD No 93
Tata Memorial Hospital
Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7045714838 |
| Fax |
|
| Email |
jifmijosemanjali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jifmi Jose Manjali |
| Designation |
Associate Professor Radiation Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Main Building Ground Floor OPD No 93
Tata Memorial Hospital
Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7045714838 |
| Fax |
|
| Email |
jifmijosemanjali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jifmi Jose Manjali |
| Designation |
Associate Professor Radiation Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Main Building Ground Floor OPD No 93
Tata Memorial Hospital
Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7045714838 |
| Fax |
|
| Email |
jifmijosemanjali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Funding TRAC, Tata Memorial Hospital, Main Building, 3rd Floor, Dr. E. Borges Road, Parel, Mumbai – 400012, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre Mumbai |
| Address |
Dr. Ernest Borges Road, Tata Memorial Hospital,Parel, Mumbai 400012 Maharashtra India |
| 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 Jifmi Jose Manjali |
Tata Memorial Hospital |
Department of Bone and Soft Tissue Radiation Oncology, Room No.93, Main Building, Ground Floor, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai – 400012, Maharashtra, India.
Mumbai
MAHARASHTRA |
7045714838
jifmijosemanjali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institututional Ethics Committee I Tata Memorial Hospital Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C49||Malignant neoplasm of other connective and soft tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Fractionated Radiotherapy (SF-NART) |
Dose: 50 Gy in 25 fractions (2 Gy/fraction)
Schedule: Daily over 5–7 weeks
Technique: IMRT/VMAT or IMPT (proton therapy)
Planning: CT-based planning with MRI fusion; standard GTV–CTV–PTV margins
Image Guidance: As per institutional protocol (2–5 times/week)
Monitoring: Toxicity assessment using RTOG/CTCAE v5.0
Surgery: Planned 5–8 weeks post-radiotherapy
Adjuvant Therapy: As per institutional guidelines |
| Intervention |
Ultra Hypofractionated Radiotherapy(UH-NART) |
Intervention Details-
Dose & Schedule 25–30 Gy in 5 fractions 5–6 Gy/fraction, given on alternate days over 2–3 weeks
Technique: IMRT/VMAT or IMPT (proton therapy)
Planning: CT-based planning with MRI fusion; standard GTV–CTV–PTV margins
Image Guidance: Daily IGRT (CBCT/MVCT)
Monitoring: Toxicity assessment using RTOG/CTCAE v5.0
Surgery: Planned 5–8 weeks post-radiotherapy
Adjuvant Therapy: As per institutional guidelines |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
greater than or equal to 18 years of age
Karnofsky Performance Status KPS 70 or above
Core needle biopsy obtained for pathologic confirmation of primary soft tissue sarcoma FNCLCC grading intermediate or high
Site extremities and limb girdles (scapula and pelvis)
Localised disease – primary or recurrent
Size less than 30cm
Prior inappropriate biopsy or unplanned surgery in single specimen which is planned for re-surgery as per clinical decision
MR imaging of the primary tumour at diagnosis
Medically and surgically operable documentation of resectability after appropriate evaluation by orthopaedic oncosurgeons
Informed consent obtained prior to inclusion
Patient willing and reliable for follow up and QOL
|
|
| ExclusionCriteria |
| Details |
Locally advanced presence of lymph nodes and metastatic disease
Prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
Pregnant women
Round cell sarcoma histologies
Patients with a synchronous primary cancer requiring treatment
STS of headneck retroperitoneum or chestwall regions
Tumor size greater than or equal to 30 cm in any plane
Tumours requiring vascular reconstruction
Patients with known immunosuppression HIV or history of longterm steroid intake or uncontrolled diabetes HbA1C greater than 7
Complete microscopic resection of tumour deemed unfeasible or doubtful
Prior piece meal unplanned surgery
Patients unfit for general anaesthesia medically inoperable
Any contraindication to radiotherapy like DNA repair syndromes
Unable to follow up or poor logistic or social support
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 3-yr local recurrence free survival (LRFS) |
Assessed up to 3 years after surgery/treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Major wound complication rate within 90 days after surgery
Acute radiation toxicity (within 6 weeks of radiotherapy completion)
Late radiation toxicity (fibrosis, edema, joint stiffness)
Disease Free Survival (DFS)
Overall Survival (OS)
Radiological response using RECIST criteria
Pathological necrosis percentage
R0 resection rates
Functional outcome using Toronto Extremity Salvage Score (TESS)
Patient satisfaction using EORTC OUT-PATSAT7 questionnaire
Direct patient expenditure (travel, food, stay) |
Major wound complication rate -Within 90 days after surgery
Acute radiation toxicity (RTOG/CTCAE grading)-Within 6 weeks after completion of radiotherapy
Late radiation toxicity (fibrosis, subcutaneous edema, joint stiffness, skin toxicity)-Assessed from 6 weeks post-RT up to 3 years follow-up
Disease Free Survival (DFS)-3 years after treatment
Overall Survival (OS)-3 years after treatment
Radiological response assessed using RECIST criteria on MRI-4–8 weeks after completion of radiotherapy
Pathological tumor necrosis percentage-At time of surgery
R0 resection rate (complete surgical resection with negative margins)-At time of surgery
Functional outcome assessed using Toronto Extremity Salvage Score (TESS)-At baseline (enrollment) and during follow-up up to 3 years
Patient experience assessed using EORTC OUT-PATSAT7 questionnaire-At baseline (enrollment) and during follow-up visits
Direct expenditure incurred by patients (travel, stay, food costs)-During treatment and follow-up period
|
|
|
Target Sample Size
|
Total Sample Size="372"
Sample Size from India="372"
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)
|
19/04/2027 |
| 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="8"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 randomized, open-label, phase II trial comparing ultra-hypofractionated pre-operative radiotherapy (UH-NART) with standard fractionated pre-operative radiotherapy (SF-NART) in patients with soft tissue sarcoma of the extremities and limb girdles. A total of 372 patients will be randomized in a 1:1 ratio to receive either 25–30 Gy in 5 fractions (UH-NART) or 50 Gy in 25 fractions (SF-NART) prior to surgery. The primary objective is to compare 3-year local recurrence-free survival (LRFS) between the two treatment arms. Secondary outcomes include major wound complications, acute and late toxicities, disease-free survival, overall survival, radiological and pathological response, functional outcomes, quality of life, and direct treatment-related expenditure. |