The Prone Breast Radiation Therapy Trial

NCT ID: NCT01815476

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 378 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-04
• Study Completion Date: 2019-06-30

Brief Summary

Participants undergoing radiation after breast conserving surgery for an early breast cancer (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at increased risk of developing a skin reaction because of their large breast size.

After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or early stage invasive breast cancer receive radiation to the breast to decrease the risk of cancer recurrence. Breast radiation is usually done with women lying on their back ("supine"). Some women develop temporary breakdown of the skin (moist desquamation). This skin reaction can be painful and has been linked to long term side effects such as chronic pain and decreased quality of life.

This study is being done because women with large breasts have higher rates of skin breakdown (called 'moist desquamation') and breast pain during and shortly after radiation therapy is complete. It is unclear if such skin reactions and pain would be improved by alternating treatment position - namely lying on your belly ("prone") during their radiation treatment.

Detailed Description

The risk of moist desquamation in large breasted women remains unacceptably high and reactions tends to be severe and produce significant permanent and delayed side effects. Evidence suggests that the use of a prone breast IMRT technique has the potential to decrease the risk of moist desquamation in large breasted women to the levels that are now seen when average/smaller breasted women are treated with supine IMRT. As prone breast XRT is currently only offered at 6 of 15 of the Ontario Cancer Centres polled for the purposes of providing motivation for this study, a multicentre RCT is feasible to confirm and quantify the improvement provided by the prone technique and provide Level 1 evidence for it to be adopted world-wide.

Conditions

Ductal Carcinoma In Situ; Invasive Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RT Positioning Intervention: Supine

Patient will be treated in a supine position as per standard of care/control.

Group Type: OTHER

Radiation Therapy Positioning Intervention

Intervention Type: RADIATION

All participants will receive an adjuvant XRT dose to the breast of 50Gy in 25 fractions using an IMRT technique. In both arms, boost to the surgical bed using a mini-tangent technique will be delivered at the treating oncologist's discretion. Acceptable boost doses are 1600cGy/8 fractions, 1000cGy/5 fractions or 1325cGy/25 fractions as a simulatenous integrated boost. Participants randomized to the supine arm will be positioned supine on an angled breast board, with the ipsilateral arm abducted over her head. Participants randomized to the prone arm will be positioned prone on a prone breast board with both arms immobilized above the participant's head. The us of a cushion-like VaclocTM device is permitted at the treating physician's discretion. Radiation beams will be shaped to encompass the breast volume requiring treatment in both arms.

RT Positioning Intervention: Prone

Patient will be treated in the prone position.

Group Type: EXPERIMENTAL

Radiation Therapy Positioning Intervention

Intervention Type: RADIATION

All participants will receive an adjuvant XRT dose to the breast of 50Gy in 25 fractions using an IMRT technique. In both arms, boost to the surgical bed using a mini-tangent technique will be delivered at the treating oncologist's discretion. Acceptable boost doses are 1600cGy/8 fractions, 1000cGy/5 fractions or 1325cGy/25 fractions as a simulatenous integrated boost. Participants randomized to the supine arm will be positioned supine on an angled breast board, with the ipsilateral arm abducted over her head. Participants randomized to the prone arm will be positioned prone on a prone breast board with both arms immobilized above the participant's head. The us of a cushion-like VaclocTM device is permitted at the treating physician's discretion. Radiation beams will be shaped to encompass the breast volume requiring treatment in both arms.

Interventions

Radiation Therapy Positioning Intervention

All participants will receive an adjuvant XRT dose to the breast of 50Gy in 25 fractions using an IMRT technique. In both arms, boost to the surgical bed using a mini-tangent technique will be delivered at the treating oncologist's discretion. Acceptable boost doses are 1600cGy/8 fractions, 1000cGy/5 fractions or 1325cGy/25 fractions as a simulatenous integrated boost. Participants randomized to the supine arm will be positioned supine on an angled breast board, with the ipsilateral arm abducted over her head. Participants randomized to the prone arm will be positioned prone on a prone breast board with both arms immobilized above the participant's head. The us of a cushion-like VaclocTM device is permitted at the treating physician's discretion. Radiation beams will be shaped to encompass the breast volume requiring treatment in both arms.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• confirmed histological diagnosis of breast carcinoma or ductal carcinoma in situ (DCIS);
• treated with BCT;
• no indication for treatment of regional LN;
• Women with a bra size of 40 inches or greater, or a pre-surgery cup size of D or greater

Exclusion Criteria

• Regional Lymph Node XRT indicated;
• Bilateral breast cancer;
• unhealed wound (skin not closed and/or infection);
• previous XRT to the same breast;
• unable to lie prone;
• presence of active connective tissue disease;
• pregnancy;
• unacceptable heart exposure (as measured by > 10% of the heart receiving 50% of the prescribed dose, i.e. V25Gy > 10%);
• adequate coverage of postoperative tumour bed not technically possible

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Breast Cancer Foundation

OTHER

Sponsor Role: collaborator

Toronto Sunnybrook Regional Cancer Centre

OTHER

Sponsor Role: lead

Responsible Party

Danny Vesprini, MD, MSc, FRCPC

Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danny Vesprini, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

Toronto Sunnybrook Regional Cancer Centre

Locations

British Columbia Cancer Agency - Vancouver Island centre

Victoria, British Columbia, Canada

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

References

Vesprini D, Davidson M, Bosnic S, Truong P, Vallieres I, Fenkell L, Comsa D, El-Mallah M, Garcia L, Stevens C, Nakonechny K, Tran W, Kiss A, Rakovitch E, Pignol JP. Effect of Supine vs Prone Breast Radiotherapy on Acute Toxic Effects of the Skin Among Women With Large Breast Size: A Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):994-1000. doi: 10.1001/jamaoncol.2022.1479.

Reference Type: DERIVED

PMID: 35616948 (View on PubMed)

Other Identifiers

380-2012

Identifier Type: -

Identifier Source: org_study_id