Highly Accelerated Dose-Integrated Radiotherapy in 5 Fractions in Breast Cancer

NCT04098926 | Completed

• 1 other identifier: EC/2014/1167
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Adjuvant radiotherapy in breast cancer improves local control, also in the elderly. Hormonal therapy in hormone sensitive tumors improves results but can not substitute radiotherapy. Improved local control leads to less breast cancer related morbidity and mortality, also in an older population (Schonberg, JCO, 2011). Unfortunately, in older patients with lower life expectancy, adjuvant radiotherapy is often omitted. Following reasons are invoked:

• frailty of the patient
• fear for toxicity
• impaired mobility, rendering transportation and positioning more difficult
• dependency for transportation to and from the radiotherapy departement
• negative cost effectiveness ratio, due to high cost (especially for complex techniques and long schedules) and lower benefit (lower life expectancy) Hypofractionation is feasible without increased toxicity, and combines better local control with patient comfort and lower costs. Further lowering the number of fractions (from 15-21 to 5) will further improve patient comfort, but is challenging when different doses are needed in the same target volume. This problem is addressed using advanced techniques permitting dose-integration. In the elder with cancer, several unrecognized geriatric problems, including depression and cognitive impairment, can be detected by CGA . Some problems do interact with cancer treatment. In this study screening and assessment is provided to support patients and to develop an inventory of radiotherapy obstacles. Our study includes breast cancer patients, ≥70 years old, referred for adjuvant radiotherapy after surgical treatment. A schedule of 5 fractions is offered, encompassing different targets of treatment.

Conditions

Breast Cancer; Radiotherapy

Keywords

Older women; Accelerated radiotherapy; Dose-integrated radiotherapy

Outcome Measures

Primary Outcomes (1)

• Breast retraction (LENTSOMA)

  Breast Cancer Conservative treatment.core (BCCT.core) objective measurement

  6 weeks post-radiotherapy

Secondary Outcomes (16)

• Acute toxicity: number of patients with clinical relevant dermatitis (CTCAE v. 4.0)

  1-8 weeks

• Acute toxicity: number of patients with moist desquamation (CTCAE v. 4.0 (grade 3)

  1-8 weeks

• Acute toxicity: number of patients with pain (CTCAE v. 4.0)

  1-8 weeks

• Acute toxicity: number of patients with pruritus (CTCAE v. 4.0)

  1-8 weeks

• Acute toxicity: number of patients with fatigue (MFI-20)

  1-8 weeks

Study Arms (2)

Accelerated dose-integrated radiotherapy - pN0

EXPERIMENTAL

Lymph node negative breast cancer

Radiation: Dose-integrated accelerated EBRT in pN0 breast cancer

Accelerated dose-integrated radiotherapy - pN1

EXPERIMENTAL

Lymph node positive breast cancer

Radiation: Dose-integrated accelerated EBRT in pN+ breast cancer

Interventions

Dose-integrated accelerated EBRT in pN0 breast cancer RADIATION

WBI: 5 x 5.7Gy Thoracic wall: 5 x 5.7Gy R0 boost: 5 x 6.5Gy R1 boost: 5 x 6.9Gy

Accelerated dose-integrated radiotherapy - pN0

Dose-integrated accelerated EBRT in pN+ breast cancer RADIATION

WBI: 5 x 5.7Gy Thoracic wall: 5 x 5.7Gy R0 boost: 5 x 6.5Gy R1 boost: 5 x 6.9Gy Lymph node region: 5 x 5.4Gy

Accelerated dose-integrated radiotherapy - pN1

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 70 years old
• AND breast conserving surgery or mastectomy for breast carcinoma
• AND multidisciplinary decision of adjuvant irradiation
• AND absence of distant metastases
• AND informed consent obtained, signed and dated before specific protocol procedures

You may not qualify if:

• Bilateral breast irradiation
• In case of mastectomy: positive resection margin, needing boost
• Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
• Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
• History of previous radiation treatment to the same region

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital - Radiotherapy Department

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: September 23, 2019
• Study Start: January 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 13, 2018
• Last Updated: September 23, 2019

Record last verified: 2015-06

Locations

BE (1)