Whole Breast Irradiation vs Twice Daily vs. Once Daily Accelerated Partial Breast Irradiation

NCT03616626 | Unknown

• 1 other identifier: NCI-BC-12/2012
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized phase III trial in women with invasive carcinoma of the breast with negative axillary nodes treated by Breast Conserving Surgery (BCS). Eligible, patients will be randomly allocated to receive radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Whole Breast Irradiation (WBI) 50 Gray (Gy) in 25 daily fractions over 5 weeks or Accelerated Partial Breast Irradiation (APBI) 38.5 Gy in 10 daily fractions of 3.85Gy over two weeks or 38.5 Gy in 10 twice daily fractions of 3.85Gy over one week. Patients will be followed at 6, 12, 18 and 24 months post randomization. Cosmetic outcome will be measured using photographs and evaluated by a panel of trained radiation oncologists. Radiation toxicity will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).

Conditions

Breast Cancer; Radiation Toxicity

Keywords

Breast Cancer; Accelerated partial Breast Irradiation; Breast cosmesis; radiation Toxicity

Outcome Measures

Primary Outcomes (1)

• Change in the Adverse cosmetic outcome using the EORTC Breast Cosmetic Rating System

  The primary outcome is the change in the adverse cosmesis assessed prior to radiation, 6, 12 and 18 months after end of radiation. The cosmetic outcome will be assessed by a radiation oncologist who is unaware of treatment allocation, using the EORTC Breast Cosmetic Rating System.

  prior to radiation, 6,12 and 18 months after radiation

Secondary Outcomes (4)

• Ipsilateral Breast Tumor Recurrence (IBTR)

  throughout the study up to 5 years

• Disease Free Survival

  throughout the study up to 5 years

• Overall Survival

  From date of randomization until the date of death up to 5 years

• Radiation Induced Early and late toxicities

  during radiation and at 6, 12 and 18 months after radiation

Study Arms (3)

Whole Breast Irradiation

ACTIVE COMPARATOR

Adjuvant 3D Conformal Radiation Therapy to a dose of 50 Gy in 25 fractions over 5 weeks. Boost is given as 10 Gy in 5 fractions over one week to patients with high grade tumors or age younger than 50 years

Radiation: Whole Breast Irradiation

Once Daily APBI

EXPERIMENTAL

Adjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 once daily fractions given over 2 weeks

Radiation: Once Daily APBI

Twice Daily APBI

EXPERIMENTAL

Adjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 twice daily fractions given over 1 week

Radiation: Twice Daily APBI

Interventions

Once Daily APBI RADIATION

Adjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 once daily fractions given over 2 weeks

Once Daily APBI

Twice Daily APBI RADIATION

Adjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 twice daily fractions given over 1 week

Twice Daily APBI

Whole Breast Irradiation RADIATION

Adjuvant 3D Conformal Radiation Therapy to a dose of 50 Gy in 25 fractions over 5 weeks. Boost is given as 10 Gy in 5 fractions over one week to patients with high grade tumors or age younger than 50 years

Whole Breast Irradiation

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tumor characteristics
• Histologically confirmed invasive adenocarcinoma of the breast
• Tumors must be ≤ 3 cm. Gross disease must be unifocal. Negative lymph nodes
• Hormone receptor status:
• Estrogen receptor (ER) status known Progesterone status known if ER analysis is negative Marginal or borderline results are considered positive Surgery
• Tumor removed with conservative breast surgery with adequate margin
• Re-excision of surgical margins allowed
• No prior breast implants
• Prior axillary staging required for patients including 1 of the following:
• Sentinel node biopsy alone (if sentinel node is negative)
• Sentinel node biopsy followed by axillary dissection if sentinel node is positive)
• Axillary dissection alone with ≥ 6 axillary nodes
• Target lumpectomy cavity clearly delineated AND target lumpectomy/whole breast reference volume ≤ 30% based on postoperative pre-randomization CT scan
• Final surgery (i.e., lumpectomy, re-excision of margins, or axillary staging procedure) within the past 42 days
• No prior biologic therapy for this malignancy Chemotherapy

You may not qualify if:

• Multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm.
• Non-epithelial breast malignancies (e.g., sarcoma or lymphoma).
• Positive axillary nodes.
• Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor.
• Suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign
• Paget's disease of the nipple
• Previous history of invasive breast cancer or DCIS.
• Synchronous bilateral invasive or non-invasive breast cancer
• Collagen vascular disease (e.g., systemic lupus erythematosus or scleroderma), specifically dermatomyositis with a CPK level above normal, or active skin rash
• Psychiatric or addictive disorder that would preclude study therapy

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

Location

Related Publications (7)

• Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22.

  PMID: 19395195 RESULT

• Jagsi R, Ben-David MA, Moran JM, Marsh RB, Griffith KA, Hayman JA, Pierce LJ. Unacceptable cosmesis in a protocol investigating intensity-modulated radiotherapy with active breathing control for accelerated partial-breast irradiation. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):71-8. doi: 10.1016/j.ijrobp.2009.01.041.

  PMID: 19409733 RESULT

• Vicini F, Winter K, Wong J, Pass H, Rabinovitch R, Chafe S, Arthur D, Petersen I, White J, McCormick B. Initial efficacy results of RTOG 0319: three-dimensional conformal radiation therapy (3D-CRT) confined to the region of the lumpectomy cavity for stage I/ II breast carcinoma. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1120-7. doi: 10.1016/j.ijrobp.2009.06.067. Epub 2009 Nov 10.

  PMID: 19910132 RESULT

• Chen PY, Wallace M, Mitchell C, Grills I, Kestin L, Fowler A, Martinez A, Vicini F. Four-year efficacy, cosmesis, and toxicity using three-dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):991-7. doi: 10.1016/j.ijrobp.2009.03.012. Epub 2009 Jun 8.

  PMID: 19515514 RESULT

• Goyal S, Daroui P, Khan AJ, Kearney T, Kirstein L, Haffty BG. Three-year outcomes of a once daily fractionation scheme for accelerated partial breast irradiation (APBI) using 3-D conformal radiotherapy (3D-CRT). Cancer Med. 2013 Dec;2(6):964-71. doi: 10.1002/cam4.157. Epub 2013 Oct 31.

  PMID: 24403270 RESULT

• DE Paula U, D'Angelillo RM, Barbara R, Caruso C, Gomellini S, Caccavari A, Costarelli L, Scavina P, Mauri M, Santini E, Antonaci A, Cavaliere F, LA Pinta M, Loreti A, Fortunato L. Once Daily Accelerated Partial Breast Irradiation: Preliminary Results with Helical Tomotherapy(R). Anticancer Res. 2016 Jun;36(6):3035-9.

  PMID: 27272823 RESULT

• Bentzen SM, Yarnold JR. Reports of unexpected late side effects of accelerated partial breast irradiation--radiobiological considerations. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):969-73. doi: 10.1016/j.ijrobp.2010.01.059. No abstract available.

  PMID: 20610037 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Rimoun Boutrus, M.D.

  Radiation Oncology Department, National Cancer Institute, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Radiation Oncology

Study Record Dates

• First Submitted: July 28, 2018
• First Posted: August 6, 2018
• Study Start: July 1, 2013
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2021
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

EG (1)