CTRI

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CTRI Number

CTRI/2024/10/074718 [Registered on: 04/10/2024] Trial Registered Prospectively

Last Modified On:

05/06/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Radiation Therapy

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Acute skin toxicity comparison of adjuvant two-weekly versus three-weekly radiotherapy in breast cancer

Scientific Title of Study

Acute skin toxicity comparison of adjuvant two-weekly accelerated hypofractionated versus three-weekly moderately hypofractionated radiotherapy in breast cancer- A Phase 2, open label, randomized control trial

Trial Acronym

nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Aswathi PL
Designation	Junior Resident
Affiliation	JIPMER
Address	Department of radiation oncology, Regional cancer centre, JIPMER, puducherry Pondicherry PONDICHERRY 605006 India
Phone	7907248146
Fax
Email	aswathipl1997@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Pooja Sethi
Designation	Associate professor
Affiliation	JIPMER
Address	Department of radiation oncology, Regional cancer centre, JIPMER, puducherry Pondicherry PONDICHERRY 605006 India
Phone	9543601257
Fax
Email	docpujasethi@gmail.com

Details of Contact Person
Public Query

Name	Dr Pooja Sethi
Designation	Associate professor
Affiliation	JIPMER
Address	Department of radiation oncology, Regional cancer centre, JIPMER, puducherry Pondicherry PONDICHERRY 605006 India
Phone	9543601257
Fax
Email	docpujasethi@gmail.com

Source of Monetary or Material Support

JIPMER, JIPMER CAMPUS ROAD, GORIMEDU, DHANVANTARI NAGAR, PUDUCHERRY, INDIA 605006

Primary Sponsor

Name	JIPMER
Address	JIPMER JIPMER campus road gorimedu Dhanvantari nagar,Puducherry 605006
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
Dr Aswathi PL	JIPMER	RADIATION ONCOLOGY, RCC, JIPMER, JIPMER campus road, GORIMEDU, Dhanvantari nagar, Puducherry, INDIA Pondicherry PONDICHERRY	7907248146 aswathipl1997@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

Status

Not Applicable

Health Condition / Problems Studied

Health Type

Condition

Patients

(1) ICD-10 Condition: C500||Malignant neoplasm of nipple and areola, (2) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, (3) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, (4) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (5) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, (6) ICD-10 Condition: C505||Malignant neoplasm of lower-outerquadrant of breast, (7) ICD-10 Condition: C506||Malignant neoplasm of axillary tail of breast, (8) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, (9) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Radiotherapy	Patient will be treated with standard accelerated hypo fractionated post surgery of dose dose equivalent to 34 Gy in 10 fractrions
Comparator Agent	Radiotherapy	Patient will be treated with standard hypo fractionated dose equivalent to 40 Gy / 15 fractions post surgery

Inclusion Criteria

Age From	18.00 Year(s)
Age To	50.00 Year(s)
Gender	Female
Details	1.Female 2.more than or equal to 18 years of age 3.Invasive carcinoma of breast (cT1-3,N0-2a) 4.Post breast conserving surgery/mastectomy, with clear margin of more than or equal to 1mm, with or without axillary lymph node dissection for breast cancer(pT0-T3,N0-2a) 5.Written informed consent 6.Able to comply with follow-up up to 6 months

ExclusionCriteria

Details

1.Advanced loco-regional disesase- cT4/ cN2b/cN3 tumors, known residual macroscopic local or nodal disease post-surgery, requirement for Internal mammary nodal RT (more than or equal to 4axillary nodal macrometastasis, radiologically positive IMN), Positive margin,
2.Metastatic disease
3.Breast reconstruction
4.Pregnancy
5.Prior radiotherapy in the thoracic and /or lower neck area
6.Past history of malignancy except (i) basal cell skin cancer, (ii) CIN cervix uteri or (iii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free
7.Contralateral and/or previous ipsilateral breast cancer, including DCIS, irrespective of date of diagnosis
8. Patients at low risk, eligible and willing for Accelerated partial breast irradiation (more than or equal to 50 years of age, tumor less than oe equal to 2 cm, ER-Positive, Her-2-neu -Negative, Grade 1-2, unicentric, unifocal, no EIC, LVSI, Node negative, clear surgical margin at least 2mm, no genetic mutation, no lobular pathology)

Method of Generating Random Sequence

Stratified block randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1.To compare the proportion of patients with cumulative more than or equal to grade 2 dermatitis according to RTOG Acute & CTCAE Version 5, anytime during or within 3 months post radiotherapy	during radiotherapy or within 3 months post radiotherapy

Secondary Outcome

Outcome	TimePoints
To compare the time to first occurrence of more than or equal to grade 2 skin toxicities	first occurrence of more than or equal to grade 2 skin toxicities
To compare the change in EORTC Quality of life C30 score and EORTC BR 45 score from baseline prior to radiotherapy, to 6 months post radiotherapy	6 months post radiotherapy
To compare the proportion of patients with acute toxicities other than skin, according to RTOG Acute & CTCAE Version 5 Grades during and within 3 months post radiotherapy.	3 months post radiotherapy
To compare the proportion of dosimetric feasibility on treatment planning as per protocol, between two radiation dose prescriptions	start of radiotherapy
To compare the proportion of patients with ipsilateral local and or regional nodal relapse at 6 months post radiotherapy	6 months post radiotherapy
To compare the proportion of patients with late toxicities at 3-6 months according to RTOG Late & CTCAE Version 5 Grades post radiotherapy	6 months post radiotherapy

Target Sample Size

Total Sample Size="72"
Sample Size from India="72"
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)

07/10/2024

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

Post operative breast cancer patients will be recruited into the study and randomized into two arms as control arm and intervention arm. Control arm patients will receive standard hypofractionation regimen with or with out nodal irradiation and intervention arm will receive 34Gy in 10 fractions in case of mastectomy and with tumor bed boost in case of breast conservative surgery. Patients will be reviewed 1 month, 3 months and 6 months.