Breast CancerPhase 3NCT05253170
Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients
A Phase 3 study testing Hypofractionation and Conventional Fractionation in people with Breast Cancer and Radiotherapy; Complications, run by Seoul National University Bundang Hospital.
Trial summary
This randomized Phase III study aims to show major complication rate of hypofractionation radiation therapy is not inferior, compared to conventional fractionation radiation therapy in breast cancer patients undergoing mastectomy and reconstruction surgery. Read more about this study
- Who is it for?
- Ages 19 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Radiotherapy; Complications
- What is being tested?
- Hypofractionation and Conventional Fractionation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 622 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 31 Dec 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patient who underwent mastectomy for invasive breast cancer
- Patients who have undergone breast reconstruction after mastectomy or who have inserted a tissue expander
- (y)p patients with stage IIIA or lower (excluding T4 and N3 patients) who need adjuvant radiation therapy
- Eastern Cooperative Oncology Group Performance ≤ 2
- Age ≥ 19 years
- Patients who agreed to participate in the study
Who cannot join
- Patients who already had implants at the time of diagnosis of breast cancer or who have already undergone reconstructive surgery
- Patients who underwent reconstruction after partial resection or breast conserving surgery rather than mastectomy
- Patients who are using or planning to use an air expander
- Patients receiving radiation therapy for salvage or palliative purposes
- Patients with distant metastases at the time of diagnosis
- Patients who are scheduled to undergo concurrent chemoradiation therapy
Show all 11Show fewer
- Patients with bilateral breast cancer
- Male breast cancer patients
- Patients who have previously received radiation therapy for the ipsilateral breast or supraclavicular area
- Patients with history of cancers other than thyroid cancer, intraepithelial cancer of the cervix, or skin cancer
- Patients diagnosed with ductal breast carcinoma in situ, lobular carcinoma in situ, phyllodes, metaplastic cancer, or other benign tumors based on histological diagnosis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Phase III Trial of Hypofractionated Versus Conventionally Fractionated Radiotherapy in Breast Cancer Patients With Reconstruction After Mastectomy
This randomized Phase III study aims to show major complication rate of hypofractionation radiation therapy is not inferior, compared to conventional fractionation radiation therapy in breast cancer patients undergoing mastectomy and reconstruction surgery.
Read the detailed description
This study is a multicenter, randomized, phase 3 clinical trial. For breast cancer patients who underwent breast reconstruction after mastectomy, the hypofractionation radiotherapy group (experimental group) and the conventional fractionation radiotherapy group (control group) were divided 1:1 and compared to reveal the non-inferiority with hypofractionation in terms of major complication rate.
- Primary Objective
- To show the non-inferiority of major complication rate in reconstructed-breast between the hypofractionation radiotherapy group (experimental group) and the conventional fractionation radiotherapy group (control group) at 2 years after radiation therapy.
- The main complications are defined at those requiring hospitalization or surgery among complications.
II. Secondary Objective:
- Comparison of other side effects between the two groups.
- Comparison of complication rate stratified by reconstruction timing and type of reconstruction
- Immediate implant-based reconstruction
- Immediate autologous reconstruction
- Delayed-immediate implant reconstruction (2-stage)
- Comparison of quality of life between the two groups.
- Comparison of local and regional control rates between the two groups.
III. Tertiary Objective:
- Comparison of cosmetic evaluations between the two groups.
- Dosimetry analysis for correlation between the occurrence of complications and the dose profile.
- Conditions
- Breast Cancer, Radiotherapy; Complications
- Being tested
- Hypofractionation, Conventional Fractionation
- Keywords
- Mastectomy, Reconstruction, Radiation therapy, Conventional fractionation, Hypofractionation, Complication
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypofractionationRadiation
Radiation regimen of 2.5-3.0Gy x 13-17 fractions +/- sequential boost 0-7 fractions
Conventional FractionationRadiation
Radiation regimen of 1.8-2.0Gy x 23-28 fractions +/- sequential boost 0-5 fractions
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionation | Experimental | For the cumulative total dose of 39-45.9 Gy to the chest wall, a daily dose of 2.5-3.0 Gy is administered 13-17 fractions.
* Should be started within 3 months of completion of mastectomy or chemotherapy.
* Clinical target volume (CTV) may include regional lymph nodes.
* If a tissue expander or implant is present at the time of radiotherapy planning, CTV contouring should be performed according to the ESTRO ACROP implant-based target delineation guidelines. Receives: Radiation: Hypofractionation |
| Conventional Fractionation | Active comparator | For the cumulative total dose of 45-50.4 Gy to the chest wall, a daily dose of 1.8-2.0 Gy is administered 23-28 fractions.
* Should be started within 3 months of completion of mastectomy or chemotherapy.
* Clinical target volume (CTV) may include regional lymph nodes.
* If a tissue expander or implant is present at the time of radiotherapy planning, CTV contouring should be performed according to the ESTRO ACROP implant-based target delineation guidelines. Receives: Radiation: Conventional Fractionation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Complication Rate
- Unplanned re-hospitalization or re-operation for intervention
- Implant removal due to infection, autologous flap total failure (reconstruction failure)
Measured: Up to 2 years after the completion of radiation therapy
Capsular Contracture (If implant-based recontruction is performed)
- Baker Scale
- G1: the breast is normally soft and appears natural in size and shape
- G2: the breast is a little firm, but appears normal
- G3: the breast is firm and appears abnormal
- G4: the breast is hard, painful to the touch, and appears abnormal
Measured: Up to 2 years after the completion of radiation therapy
Secondary outcomes (4)
Hematoma
NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0
- G1: Mild symptoms; intervention not indicated
- G2: Minimally invasive evacuation or aspiration indicated
- G3: Transfusion; invasive intervention indicated
- G4: Life-threatening consequences; urgent intervention indicated
- G5: Death
Measured: Up to 2 years after the completion of radiation therapy
Wound infection
NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0
- G1: Localized, local intervention indicate
- G2: Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
- G3: IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
- G4: Life-threatening consequences; urgent intervention indicated
- G5: Death
Measured: Up to 2 years after the completion of radiation therapy
Wound Dehiscence
NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0
- G1: Incisional separation, intervention not indicated
- G2: Incisional separation, local care (e.g., suturing) or medical intervention indicated (e.g., analgesic)
- G3: Fascial disruption or dehiscence without evisceration; revision by operative intervention indicated
- G4: Life-threatening consequences; symptomatic hernia with evidence of strangulation; fascial disruption with evisceration; major reconstruction flap, grafting, resection, or amputation indicated
- G5: Death
Measured: Up to 2 years after the completion of radiation therapy
Seroma
NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0
- G1: Asymptomatic; clinical or diagnostic observations only; intervention not indicated
- G2: Symptomatic; simple aspiration indicated
- G3: Symptomatic, elective invasive intervention indicated
Measured: Up to 2 years after the completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Apr 2022 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 622 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital
- Responsible party
- Principal investigator, In Ah Kim, Seoul National University Bundang Hospital
- Investigators
- In Ah Kim, MD. PhD., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253170
- Sponsor's protocol ID
- KROG 21-07
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial of Hypofractionated Versus Conventionally Fractionated Radiotherapy in Breast Cancer Patients With Reconstruction After Mastectomy
- ClinicalTrials.gov ID
- NCT05253170
- Acronym / sponsor ID
- KROG 21-07
- Conditions
- Breast Cancer, Radiotherapy; Complications
- Keywords
- Mastectomy, Reconstruction, Radiation therapy, Conventional fractionation, Hypofractionation, Complication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 622 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Hospital
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized Phase III study aims to show major complication rate of hypofractionation radiation therapy is not inferior, compared to conventional fractionation radiation therapy in breast cancer patients undergoing mastectomy and reconstruction surgery.
Detailed description
This study is a multicenter, randomized, phase 3 clinical trial. For breast cancer patients who underwent breast reconstruction after mastectomy, the hypofractionation radiotherapy group (experimental group) and the conventional fractionation radiotherapy group (control group) were divided 1:1 and compared to reveal the non-inferiority with hypofractionation in terms of major complication rate.
- Primary Objective
- To show the non-inferiority of major complication rate in reconstructed-breast between the hypofractionation radiotherapy group (experimental group) and the conventional fractionation radiotherapy group (control group) at 2 years after radiation therapy.
- The main complications are defined at those requiring hospitalization or surgery among complications.
II. Secondary Objective:
- Comparison of other side effects between the two groups.
- Comparison of complication rate stratified by reconstruction timing and type of reconstruction
- Immediate implant-based reconstruction
- Immediate autologous reconstruction
- Delayed-immediate implant reconstruction (2-stage)
- Comparison of quality of life between the two groups.
- Comparison of local and regional control rates between the two groups.
III. Tertiary Objective:
- Comparison of cosmetic evaluations between the two groups.
- Dosimetry analysis for correlation between the occurrence of complications and the dose profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionation | Experimental | Radiation: HypofractionationFor the cumulative total dose of 39-45.9 Gy to the chest wall, a daily dose of 2.5-3.0 Gy is administered 13-17 fractions. * Should be started within 3 months of completion of mastectomy or chemotherapy. * Clinical target volume (CTV) may include regional lymph nodes. * If a tissue expander or implant is present at the time of radiotherapy planning, CTV contouring should be performed according to the ESTRO ACROP implant-based target delineation guidelines. |
| Conventional Fractionation | Active comparator | Radiation: Conventional FractionationFor the cumulative total dose of 45-50.4 Gy to the chest wall, a daily dose of 1.8-2.0 Gy is administered 23-28 fractions. * Should be started within 3 months of completion of mastectomy or chemotherapy. * Clinical target volume (CTV) may include regional lymph nodes. * If a tissue expander or implant is present at the time of radiotherapy planning, CTV contouring should be performed according to the ESTRO ACROP implant-based target delineation guidelines. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patient who underwent mastectomy for invasive breast cancer
- Patients who have undergone breast reconstruction after mastectomy or who have inserted a tissue expander
- (y)p patients with stage IIIA or lower (excluding T4 and N3 patients) who need adjuvant radiation therapy
- Eastern Cooperative Oncology Group Performance ≤ 2
- Age ≥ 19 years
Key exclusion criteria (11 listed)
- Patients who already had implants at the time of diagnosis of breast cancer or who have already undergone reconstructive surgery
- Patients who underwent reconstruction after partial resection or breast conserving surgery rather than mastectomy
- Patients who are using or planning to use an air expander
- Patients receiving radiation therapy for salvage or palliative purposes
- Patients with distant metastases at the time of diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypofractionationRadiation regimen of 2.5-3.0Gy x 13-17 fractions +/- sequential boost 0-7 fractions | Radiation | Hypofractionation |
| Conventional FractionationRadiation regimen of 1.8-2.0Gy x 23-28 fractions +/- sequential boost 0-5 fractions | Radiation | Conventional Fractionation |
Primary outcome
Major Complication Rate
Time frame: Up to 2 years after the completion of radiation therapy
* Unplanned re-hospitalization or re-operation for intervention * Implant removal due to infection, autologous flap total failure (reconstruction failure)
Capsular Contracture (If implant-based recontruction is performed)
Time frame: Up to 2 years after the completion of radiation therapy
• Baker Scale * G1: the breast is normally soft and appears natural in size and shape * G2: the breast is a little firm, but appears normal * G3: the breast is firm and appears abnormal * G4: the breast is hard, painful to the touch, and appears abnormal
4 secondary outcomes
Hematoma
Time frame: Up to 2 years after the completion of radiation therapy
Wound infection
Time frame: Up to 2 years after the completion of radiation therapy
Wound Dehiscence
Time frame: Up to 2 years after the completion of radiation therapy
Seroma
Time frame: Up to 2 years after the completion of radiation therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
In Ah Kim, MD. PhD. principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypofractionation and Conventional Fractionation in people with Breast Cancer and Radiotherapy; Complications, run by Seoul National University Bundang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact In Ah Kim, MD. PhD. (31-787-7651 ext. +82, inah228@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Complication Rate (time frame: Up to 2 years after the completion of radiation therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.