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Optimum sequence of radiation and chemotherapy in breast cancer

Standardizing sequence of Adjuvant Radiation and Systemic therapy for breast cancer (STARS): A phase III randomized controlled trial - STARS

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036621
Enrollment
1234
Registered
2021-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C508- Malignant neoplasm of overlappingsites of breast

Interventions

Intervention1: Radiation followed by adjuvant Chemotherapy: Patients will receive Radiation followed by adjuvant Chemotherapy Control Intervention1: Chemotherapy followed by adjuvant Radiation: Patien

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: � Age 18 - 75 years � Female patients � Biopsy proven IDC (any grade) � Stage: T1-4b; N0-2; M0 � ER/PR/Her2neu-Any � ECOG PS 0-1 � 2DECHO-LVEF 50-60% � No history of prior anti-cancer treatment with radiotherapy, chemotherapy, or surgery � Patient must sign an informed consent before entry into the study

Exclusion criteria

Exclusion criteria: � Age >75 years and � Previous history of radiotherapy � Recurrent disease� Patients with significant co-morbid condition � History of previous malignancy � Not compliant for regular follow up

Design outcomes

Primary

MeasureTime frame
To compare Loco-regional recurrence free survival (LRRFS) at 5 yearsTimepoint: To compare Loco-regional recurrence free survival (LRRFS) at 5 years

Secondary

MeasureTime frame
1) Ipsilateral breast tumor recurrence (IBTR) at 5 years 2) To compare 5 year OS 3) To compare Distant metastasis free survival 4) Impact of annual PET CT scan for detection of early metastasisTimepoint: 5 years

Countries

India

Contacts

Public ContactSupriya Mallick

National Cancer Institute, AIIMS, New Delhi

drsupriyamallick@gmail.com9910453489

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026