Pre- or Postoperative Accelerated Radiotherapy

NCT03783364 | Completed DMC

• 1 other identifier: EC /2018/0996
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

20 non-metastasized breast cancer patients receiving neoadjuvant chemotherapy will be randomized between preop or postop RT. Patients with clinically suspicious axillary lymph nodes will receive a fine needle biopsy. Patients receiving postop RT will receive neoadjuvant CT followed by surgery (21-28 days after CT) and adjuvant RT starting 28-35 days after surgery. Patients receiving preop RT will receive RT first, followed by CT (5-8 days after the end of RT) and surgery (21-28 days after CT). All patients will receive a clip to locate the tumor before the start of any treatment.

Conditions

Breast Cancer; Radiation Toxicity

Outcome Measures

Primary Outcomes (1)

• Feasibility of preop RT will be assessed in terms of overall treatment time

  Treatment time will be measured.

  4 years

Secondary Outcomes (18)

• Breast symptoms: pain

  2 years

• Breast symptoms:Sense of heaviness

  2 years

• Breast symptoms:Itching

  2 years

• Arm symptoms: pain

  2 years

• Arm symptoms: sense of heaviness

  2 years

Study Arms (2)

preoperative

EXPERIMENTAL

preoperative radiotherapy

Radiation: Radiotherapy

postoperative

ACTIVE COMPARATOR

postoperative radiotherapy

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Pre- or postoperative acellerated irradition in 5 fractions

postoperative; preoperative

Eligibility Criteria

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

You may qualify if:

• female patients with non-metastatic breast cancer,
• biopsy proven,
• age ≥ 18 years,
• WHO performance status 0 or 1,
• using contraceptives if in reproductive age category
• eligible for neo-adjuvant CT after multidisciplinary decision,
• informed consent obtained, signed and dated before specific protocol procedures.

You may not qualify if:

• Any one or combination of the following:
• distant metastases,
• inflammatory breast cancer (mastitis carcinomatosa),
• multifocal tumor,
• lobular carcinoma,
• bilateral breast cancer,
• history of cancer, with the exception of non-melanoma skin cancer, in situ cervix carcinoma
• history of chemotherapy,
• history of radiation treatment,
• pregnant or breast feeding, or not using contraceptives if in reproductive age category
• leukocytes \< 2500
• absolute neutrophil count \< 1000/µL
• hemoglobine \< 8 g/dL (transfusion is allowed)
• platelets \< 100 000/µl
• total bilirubine \> 1.5 x maximal normal reference range

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Kom Op Tegen Kanker: collaborator

Study Sites (2)

Department of Radiotherapy, University Hospital Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: December 21, 2018
• Study Start: September 17, 2018
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

BE (2)