| CTRI Number |
CTRI/2024/07/070327 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of radiotherapy given before or after surgery in patients with breast cancer receiving chemotherapy before surgery. |
|
Scientific Title of Study
|
Does Neo Adjuvant Radiotherapy improve breast cancer outcomes? An Open label, randomised, parallel group, superiority trial to compare the disease free survival following NEO-adjuvant versus adjuvant HYPO-fractionated RadioTherapy in breast cancer |
| Trial Acronym |
NEO-HYPORT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjoy Chatterjee |
| Designation |
Consultant Radiation Oncology |
| Affiliation |
Tata Medical Centre, Kolkata |
| Address |
Department of radiation Oncology, Tata Medical Centre, Newtown, Kolkata
Kolkata
WEST BENGAL
700160
India |
| Phone |
9038161825 |
| Fax |
|
| Email |
sanjoy.chatterjee@tmckolkata.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjoy Chatterjee |
| Designation |
Consultant Radiation Oncology |
| Affiliation |
Tata Medical Centre, Kolkata |
| Address |
Department of radiation Oncology, Tata Medical Centre, Newtown, Kolkata
Kolkata
WEST BENGAL
700160
India |
| Phone |
9038161825 |
| Fax |
|
| Email |
sanjoy.chatterjee@tmckolkata.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjoy Chatterjee |
| Designation |
Consultant Radiation Oncology |
| Affiliation |
Tata Medical Centre, Kolkata |
| Address |
Department of radiation Oncology, Tata Medical Centre, Newtown, Kolkata
Kolkata
WEST BENGAL
700160
India |
| Phone |
9038161825 |
| Fax |
|
| Email |
sanjoy.chatterjee@tmckolkata.com |
|
|
Source of Monetary or Material Support
|
| Tata Medical Centre, 14, MAR(E-W), DH Block(Newtown), Action Area I, Newtown, Kolkata, Chakpachuria, West Bengal, India
Pin Code: 700160 |
|
|
Primary Sponsor
|
| Name |
Tata Medical Center |
| Address |
14, MAR(E-W), DH Block(Newtown), Action Area I, Newtown, Kolkata, Chakpachuria, West Bengal 700160 |
| 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 Sanjoy Chatterjee |
Tata Medical Centre |
Department of Radiation Oncology
Kolkata
WEST BENGAL |
9038161825
sanjoy.chatterjee@tmckolkata.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Medical Center-Intitutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adjuvant radiotherapy arm |
Adjuvant radiotherapy given after Surgery would be given in 5 to 15 fractions over a period of 1 to 3 weeks. |
| Intervention |
Neoadjuvant radiotherapy arm |
Neoadjuvant radiotherapy given Prior to Surgery would be given in 5 to 15 fractions over 1 to 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age ≥ 18 years
2. Patients must have a pathological proof of an invasive epithelial breast malignancy at
the treating institute. A core biopsy with adequate specimen quality is necessary for
this. FNAC alone is not sufficient. Biopsies taken outside must have been reviewed
for pathological confirmation and specimen adequacy at the treating institute.Patients
with ductal and lobular cancers are eligible for the study.
3. Receptor status (Oestrogen receptor, Progesterone receptor and HER2 neu receptor)
status should be documented. Patients can be enrolled with an equivocal HER2neu
receptor report but in all such cases a confirmatory in-situ hybridisation should be
done to confirm the status prior to initiation of taxane based chemotherapy.
4. ECOG performance status 0 - 2.
5. Clinical stage I - III disease as documented with adequate pretreatment staging.
Adequate staging include either of the two following options:
a. Whole body 18-FDG PET CT (preferred)
b. Contrast enhanced CT scan of the thorax and abdomen and a bone scan. Note
that chest X ray or USG abdomen are not acceptable substitutes.
6. Patients should have been planned for neoadjuvant chemotherapy as per institutional
protocol.
7. Patients with tumour that is likely to be amenable for curative intent resection of the
breast primary, following neoadjuvant therapy.
8. If the patient had nodal disease in the supraclavicular fossa (proven pathologically) or
internal mammary nodes (proven radiologically or pathologically), then residual gross
nodes should not be present in these regions post NACT. |
|
| ExclusionCriteria |
| Details |
1. Patients planned for therapeutic mammoplasty.
2. Patients planned for chest wall perforator flaps. This criteria will be re-evaluated after
the data from the perforator substudy is available and has been reviewed by the
DSMC.
3. Patients with non-epithelial malignant conditions of breast viz. Sarcomas, lymphomas
and phyllodes breast tumours.
4. Patients with skin cancer affecting the breast.
5. Prior radiotherapy to the ipsilateral breast or chest wall or mediastinum.
6. Concurrent illness, including severe infection that may jeopardise the ability of the
patient to undergo the procedures outlined in this protocol with reasonable safety
7. Serious medical or psychiatric conditions that might limit the ability of the patient to
comply with the protocol.
Patients enrolled for trials of investigational drugs should not be enrolled for this study. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Any Breast cancer recurrence, local/regional/distant, development of ipsilateral or contralateral invasive breast cancer, ductal carcinoma in situ or any invasive second malignancy or death |
At 7 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient reported breast / chest wall induration |
At 3 years |
Additional cancer outcomes: Overall survival, Locoregional recurrence free survival, Distant metastasis free survival Patient reported outcomes
Clinician reported toxicity
|
At 3 years
|
|
|
Target Sample Size
|
Total Sample Size="1121"
Sample Size from India="1121"
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)
|
01/08/2024 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Neoadjuvant systemic therapy is commonly used to downstage breast cancers prior to surgical curative resection. This is conventionally followed by adjuvant radiation therapy (ART) to improve local control as well as distant metastatic spread. There is credible data suggesting that a change in sequencing of radiation therapy from ART to neoadjuvant radiotherapy (NART) is likely to improve disease control. Studies support the concept of enhanced immune modulation following radiation therapy thereby improving local response to breast cancer and also reducing the risk of systemic disease progression. Modern literature has confirmed durable responses of breast cancers to local ultra hypofractionated radiotherapy. In our study, patients eligible to receive neoadjuvant systemic chemotherapy with a curable intent, will be consented. Following neo adjuvant chemotherapy, patients will be randomised between receiving pNART and ART. The primary objective of the study will be to investigate if NART improves breast cancer disease free survival compared to ART. Other secondary objectives will report locoregional control, overall survival, quality of life and safety of interventions in the treatment groups
|