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Radiation

Radiation Therapy for Breast Cancer (DCIS Trial)

N/A

Waitlist Available

Research Sponsored by Trans Tasman Radiation Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women ≥ 18 years.

Histologically proven DCIS of the breast without an invasive component.

Must not have

ECOG performance status ≥ 3.

Women who are pregnant or lactating.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline, last week of rt, 3, 6, and 12 months post rt and then yearly until year 10.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding a tumour bed boost after breast conserving surgery (BCS) in women with non-low risk ductal carcinoma in situ (DCIS) reduces the risk of local recurrence. There are two fractionation arms in this trial: a shorter fractionation arm and a standard fractionation arm. The overall objectives of the trial are to improve the outcome of women with non-low risk DCIS treated with BCS and to individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity.

Who is the study for?

This trial is for women over 18 with non-low risk DCIS of the breast, treated by breast conserving surgery. They must be clinically node-negative, able to start radiation within 12 weeks post-surgery, and have a life expectancy over 5 years. Exclusions include pregnant or lactating women, those with lymph node tumor cells, bilateral DCIS, previous contralateral breast cancer or serious diseases like scleroderma.

What is being tested?

The study tests if adding a boost after whole breast radiation (WBRT) reduces recurrence in high-risk DCIS patients and compares shorter vs standard WBRT schedules. It also aims to find molecular signatures predicting invasive recurrence to personalize treatment.

What are the potential side effects?

While not explicitly listed here, potential side effects generally associated with radiation therapy may include skin irritation at the treatment site, fatigue, mild swelling in the treated area and changes in breast texture.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 18 or older.

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My breast cancer is non-invasive and confirmed by tissue analysis.

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My cancer has not spread to my lymph nodes.

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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have significant difficulty in performing daily activities.

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I am not pregnant or breastfeeding.

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I have cancer in both breasts at the same time.

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My breast cancer has come back in the same area.

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My cancer has spread to my lymph nodes.

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I have DCIS in both breasts.

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I have had cancer in my other breast before.

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I have a serious illness like heart, lung, or kidney disease that prevents surgery or radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, last week of rt, 6, 12, 24, 60 & 120 months post rt.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline, last week of rt, 6, 12, 24, 60 & 120 months post rt.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, last week of rt, 6, 12, 24, 60 & 120 months post rt. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to local recurrence, measured from the date of randomization to the date of first evidence of local recurrence.

Secondary study objectives

Cosmetic Outcome

Overall survival

Quality of Life change

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm 4 (Shorter WB fractionation + Boost)Experimental Treatment1 Intervention

Whole breast RT + tumour bed boost - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days; Boost 16 Gy/8 fractions/10 days)

Group II: Arm 2 (Shorter WB Fractionation)Experimental Treatment1 Intervention

Whole Breast RT alone - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days)

Group III: Arm 1 (Standard WB Fractionation)Active Control1 Intervention

Whole Breast RT alone - Standard fractionation schedule (50GY/25 Fractions/35days)

Group IV: Arm 3 (Standard WB fractionation+Boost)Active Control1 Intervention

Whole Breast RT + tumor bed boost - Standard fractionation schedule (50 Gy/25 fractions/35 days; Boost 16 Gy/8 fractions/10 days)

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Trans Tasman Radiation Oncology GroupLead Sponsor

49 Previous Clinical Trials

15,014 Total Patients Enrolled

NCIC Clinical Trials GroupNETWORK

189 Previous Clinical Trials

143,233 Total Patients Enrolled

Cancer Trials IrelandNETWORK

84 Previous Clinical Trials

23,957 Total Patients Enrolled

Scottish Cancer Trials Breast GroupUNKNOWN

Borstkanker Onderzoek GroepNETWORK

22 Previous Clinical Trials

10,808 Total Patients Enrolled

European Organisation for Research and Treatment of Cancer - EORTCNETWORK

414 Previous Clinical Trials

164,002 Total Patients Enrolled

ETOP IBCSG Partners FoundationNETWORK

65 Previous Clinical Trials

56,543 Total Patients Enrolled

Breast International GroupOTHER

33 Previous Clinical Trials

52,039 Total Patients Enrolled

Boon ChuaStudy ChairPrince of Wales Hospital Randwick

1 Previous Clinical Trials

48 Total Patients Enrolled

Media Library

$Shorter WB fractionation (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT00470236 — N/A$

$Breast Carcinoma Research Study Groups: Arm 1 (Standard WB Fractionation), Arm 4 (Shorter WB fractionation + Boost), Arm 3 (Standard WB fractionation+Boost), Arm 2 (Shorter WB Fractionation)$