Late Toxicity in Breast Cancer Patients Treated With Breast-conserving Surgical Procedures and Radiotherapy Using the Simultaneous Integrated Boost Technique

NCT02505906 | Completed

• 1 other identifier: SFP2008-06
• Study Type: observational
• Target: 5,043
• Locations: 1 country
• Sites: 1

Brief Summary

In summary, breast conserving therapy (BCT) is an effective, save and widely used treatment technique for early breast cancer. Radiotherapy has shown to give better local control and survival benefit and is an integrated part of BCT. The simultaneous integrated boost (SIB) technique is a new treatment technique in breast irradiation. In this technique the whole breast is irradiated simultaneous with boosting the tumour bed, as part of BCT. Late radiation-induced toxicity has not been investigated in patients treated with radiotherapy using this technique. Proposed study will study the late radiation-induced toxicity, describe patients-rated complaints, quality of life, survival and local control curves in patients treated for early breast cancer with breast-conserving surgery in combination with radiotherapy with the SIB technique as compared to sequential radiotherapy treatment.

Conditions

Breast Cancer

Keywords

Late toxicity; Simultaneous integrated boost (SIB); Radiotherapy

Outcome Measures

Primary Outcomes (5)

• Late radiation-induced toxicity (grade 2 or higher)

  Toxicity score using Common Terminology for Adverse Events (CTCAE)

  At 1 year after completion of radiation therapy

• Late radiation-induced toxicity (grade 2 or higher)

  Toxicity score using Common Terminology for Adverse Events (CTCAE)

  At 2 years after completion of radiation therapy

• Late radiation-induced toxicity (grade 2 or higher)

  Toxicity score using Common Terminology for Adverse Events (CTCAE)

  At 3 years after completion of radiation therapy

• Late radiation-induced toxicity (grade 2 or higher)

  Toxicity score using Common Terminology for Adverse Events (CTCAE)

  At 4 years after completion of radiation therapy

• Late radiation-induced toxicity (grade 2 or higher)

  Toxicity score using Common Terminology for Adverse Events (CTCAE)

  At 5 years after completion of radiation therapy

Secondary Outcomes (6)

• Overall survival

  At 1,2,3,4 and 5 years after completion of radiation therapy

• Patient-rated symptoms

  At 1,2,3,4 and 5 years after completion of radiation therapy

• Quality of life in breast cancer patients treated with radiotherapy after breast conserving surgery

  At 1,2,3,4 and 5 years after completion of radiation therapy

• Recurrence (local)

  At 1,2,3,4 and 5 years after completion of radiation therapy

• Recurrence (regional)

  At 1,2,3,4 and 5 years after completion of radiation therapy

Interventions

Simultaneous Integrated Boost Technique RADIATION

Eligibility Criteria

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

Study Population

Patients with breast cancer treated with curative intent.

You may qualify if:

• WHO performance status 0-2.
• Invasive breast cancer or ductal carcinoma in situ (DCIS).
• Stage I-III breast cancer or DCIS.
• Treated with curative radiotherapy of the breast (as part of breast conserving therapy) with simultaneous integrated boost technique, with or without irradiation of the regional (including internal mammary) lymph nodes.

You may not qualify if:

• Previous thoracic radiotherapy.
• Previous history of malignancy, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
• Bilateral (synchrone) invasive breast cancer.
• Treatment prior to surgery (i.e. neoadjuvant chemotherapy, neoadjuvant hormonal therapy, pre-operative radiotherapy).
• Distant metastases at diagnosis (M1).
• Unsufficient knowledge of Dutch language.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 22, 2015
• Study Start: January 1, 2008
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

NL (1)