Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years (HAI-5-III)

Ghent University Hospital (UZ)

Status: Active, not recruiting

Conditions: Breastcancer

Treatments: Radiation: SIB 5 fractions if needed; Radiation: LNI 15 fractions; Radiation: TWI 15 fractions; Radiation: SIB 15 fractions if needed; Radiation: WBI 15 fractions; Radiation: LNI 5 fractions; Radiation: TWI 5 fractions; Radiation: WBI 5 fractions

Study type: Interventional

Funder types: Other

Identifiers

NCT03121248

EC/2016/1386

Details and patient eligibility

About

This study will evaluate the effect of highly accelerated external beam radiotherapy (EBRT) in 5 fractions over 10 days compared to 15 fractions over 3 weeks for early as well as locally-advanced stage breast cancer.

Primary endpoint will be chronic toxicity (breast deformation and retraction). Secondary endpoints are acute toxicity, loco-regional and distant tumor control, patient reported QoL and cosmetic satisfaction. Patients with lymph node irradiation will be closely monitored for radiation induced plexopathy.

Full description

Over the age of 65, uptake of adjuvant radiotherapy after surgery for breast cancer declines, even in women with poor prognostic stage or adverse tumor characteristics.

Lowering the number of fractions may reduce reluctancy for radiotherapy in this age group.

In a preceding prospective phase I-II trial, evaluating EBRT over 10 days, results on technical feasibility and acute toxicity were positively evaluated.

However, data on the chronic effects of breast irradiation using high doses per fraction are still sparse.

This trial is developed to compare standard hypo-fractionation in 15 fractions (if needed with simultaneously integrated boost - SIB) with highly accelerated radiotherapy in 5 fractions.

Patients referred for adjuvant radiotherapy after breast conserving surgery will preferably be randomized, depending on the indication, to a study-arm with whole breast irradiation (WBI) +/- SIB or to a study-arm with WBI+/- SIB and lymph node irradiation (LNI).

If patients after breast conserving surgery (BCS) have a strong preference for 5 or 15 fractions, they will be invited to enter the parallel observational arm (patient preference).

Patients referred for adjuvant radiotherapy after mastectomy +/- LNI accepting to participate, can choose a 5 or 15-fraction schedule. No randomization is foreseen in this last observational group.

Enrollment: 144 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• History of previous radiation treatment to the same region
• Bilateral breast irradiation
• Life expectancy of less than 2 years
• Planned reconstructive breast surgery
• Condition making toxicity evaluation difficult, e.g. skin disorders, pre-existing brachial plexus injury, ...
• Inability to respect constraints on skin, heart, lungs, esophagus, ribs, brachial plexus or any other organ at risk
• 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 or unlikely to complete the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

144 participants in 10 patient groups

WBI - randomized - 5

Experimental group

Description:

WBI 5 fractions SIB 5 fractions if needed

Treatment:

Radiation: SIB 5 fractions if needed

Radiation: WBI 5 fractions

WBI - randomized - 15

Active Comparator group

Description:

WBI 15 fractions SIB 15 fractions if needed

Treatment:

Radiation: SIB 15 fractions if needed

Radiation: WBI 15 fractions

WBI - observational - 5

Experimental group

Description:

WBI 5 fractions SIB 5 fractions if needed

Treatment:

Radiation: SIB 5 fractions if needed

Radiation: WBI 5 fractions

WBI - observational - 15

Active Comparator group

Description:

WBI 15 fractions SIB 15 fractions if needed

Treatment:

Radiation: SIB 15 fractions if needed

Radiation: WBI 15 fractions

WBI + LNI - randomized - 5

Experimental group

Description:

WBI 5 fractions SIB 5 fractions if needed LNI 5 fractions

Treatment:

Radiation: SIB 5 fractions if needed

Radiation: LNI 5 fractions

Radiation: WBI 5 fractions

WBI + LNI - randomized - 15

Active Comparator group

Description:

WBI 15 fractions SIB 15 fractions if needed LNI 15 fractions

Treatment:

Radiation: LNI 15 fractions

Radiation: SIB 15 fractions if needed

Radiation: WBI 15 fractions

WBI with LNI - observational - 5

Experimental group

Description:

WBI 5 fractions SIB 5 fractions if needed LNI 5 fractions

Treatment:

Radiation: SIB 5 fractions if needed

Radiation: LNI 5 fractions

Radiation: WBI 5 fractions

WBI with LNI - observational - 15

Active Comparator group

Description:

WBI 15 fractions SIB 15 fractions if needed LNI 15 fractions

Treatment:

Radiation: LNI 15 fractions

Radiation: SIB 15 fractions if needed

Radiation: WBI 15 fractions

thoracic wall irradiation (TWI) +/- LNI - observational - 5

Experimental group

Description:

TWI 5 fractions SIB 5 fractions if needed LNI 5 fractions

Treatment:

Radiation: LNI 5 fractions

Radiation: TWI 5 fractions

TWI +/- LNI - observational - 15

Active Comparator group

Description:

TWI 15 fractions SIB 15 fractions if needed LNI 15 fractions

Treatment:

Radiation: LNI 15 fractions

Radiation: TWI 15 fractions