Shandong Cancer Hospital Affiliated to Shandong University

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study,the eligible breast cancer patients will be randomized divided into two groups. the study group receive the accelerated hypo-fractioned whole breast irradiation with a concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control group receive conventional fractioned whole breast irradiation with a concurrent boost to the tumor bed(WBI 1.8Gy x28 and SIB 2.15Gy x28). All radiotherapy will be delivered by external beam-intensity modulated radiotherapy. the purpose of this study is to assess whether the accelerated hypo-fractioned is non-inferior to the conventional fractionated radiotherapy. The outcomes evaluation will include acute toxicity , late toxicity including breast fibrosis and cardiac disease, cosmetic outcome ,local control and survival outcome.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Early-stage Breast Cancer Breast Conserving Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HF WBI-SIB breast radiation

WBI-SIB breast radiation(WBI 2.5Gy x18 and SIB 2.88Gy x18)

Group Type EXPERIMENTAL

Whole Breast irradiation Plus simultaneous tumor bed Boost

Intervention Type RADIATION

hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group

CF WBI-SIB breast radiation

WBI-SIB breast radiation(WBI 1.8Gy x28 and SIB 2.15Gy x28)

Group Type PLACEBO_COMPARATOR

Whole Breast irradiation Plus simultaneous tumor bed Boost

Intervention Type RADIATION

hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whole Breast irradiation Plus simultaneous tumor bed Boost

hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Female patients has had breast conserving surgery
2. age ≥ 18 and ≤ 65 years
3. with a histological diagnosis of invasive carcinoma of the breast
4. with pathological stage of T1-2N0-1M0
5. multidisciplinary decision of adjuvant WBI with a boost to the tumor bed
6. informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria

1. patients treated with Mastectomy
2. Need for lymph node irradiation
3. positive or close(≤ 1 mm) surgical margin
4. treated with neoadjuvant chemotherapy before surgery
5. Bilateral malignancy of the breast (synchronous or metachronous)
6. Pregnant or breastfeeding
7. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
8. Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Min Xu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jiyan Road No.440

Jinan, Shandong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Min Xu

Role: CONTACT

Phone: +86-531-67626132

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Min Xu

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.