Back to results

Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Hypofractionated

Conventional

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Postmastectomy Hypofractionated Adjuvant Radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female
Age18-75 years
Pathologically confirmed invasive breast cancer
Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes. Immediate or delayed ipsilateral breast cancer reconstruction is accepted
Negative surgical margins
Pathologic T1-2N1 with at least one of the following risk factors: <40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression, or pT3-4, or pN2-3 (four or more positive axillary lymph nodes)
No distant metastases
No supraclavicular or internal mammary nodes metastases
ECOG:0-1
Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted.
No neoadjuvant chemotherapy
Fit for postoperative radiotherapy. No contraindications to radiotherapy
Signed informed consent

Exclusion Criteria:

Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
Previous radiotherapy to the chest wall or regional lymph node areas
Patients with severe non-malignant comorbidity in cardiovascular or respiration system
Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
pT1-2N1 with none of the following risk factors: <40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression
Patients with supraclavicular or internal mammary nodes metastases
Known definitive clinical or radiologic evidence of metastatic disease
Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
Treated with neoadjuvant chemotherapy
ECOG: 3-4
Pregnant or lactating
Conditions indicating that the patient cannot go through the radiation therapy or follow up
Unable or unwilling to sign informed consent

Sites / Locations

Suzhou Municipal hospital
Fudan University Shanghai Cancer CenterRecruiting
Huangpu Branch, Shanghai ninth people's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypofractionated

Conventional

Arm Description

42.5 Gy / 16 fractions, 2.66 Gy per fraction, 5 fractions weekly

50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly

Outcomes

Primary Outcome Measures

Loco-regional recurrence (LRR)

Defined as any clinical and biopsy-proven tumor recurrence involving the ipsilateral chest wall and/or regional nodes (including axillary, supraclavicular, infraclavicular, or internal mammary nodes). Time to loco-regional recurrence is defined as the interval starting from the date of randomization until the event. LRR will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years

Secondary Outcome Measures

Distant metastasis free survival (DMFS)

Distant metastasis is defined as clinical detection of metastatic disease beyond the chest wall and/or regional lymph nodes or death or last visit. Distant metastasis free survival (DMFS) is defined as the interval starting from the date of randomization until to the event. Distant metastasis will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years.

Disease free survival (DFS)

Defined as the interval from the date of randomization to any disease recurrence or death or last visit. It will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years

Overall survival (OS)

Defined as the interval from the date of randomization to death or last visit. It will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years

CTCAE Toxicity Assessment-Acute toxicity

Acute toxicity (development of radiation dermatitis, pruritus, pain, radiation esophagitis, and radiation pneumonitis) will be assessed according to toxicity criteria of CTCAE version 4.03 before treatment, every week of treatment, the end of treatment, 2 weeks, 3 months after the last fraction received and every year thereafter through 10 years

CTCAE Toxicity Assessment-Late toxicity

Late toxicity (development of sclerosis in irradiated area and ischemic heart disease) will be assessed according to toxicity criteria of CTCAE version 4.03 before treatment and every year through 10 years following the completion of radiotherapy

LENT-SOMA Toxicity Assessment

Development of dyspigmentation, telangiectasia in irradiated area and radiation pulmonary fibrosis will be assessed according to toxicity criteria of LENT-SOMA before treatment and every year through 10 years following the completion of radiotherapy

Number of patients with Arm Lymphedema

Arm lymphedema defined as ≥10% increase in the treated arm circumference over baseline circumference compared to the contralateral arm. Arm circumference 15 cm above the medial epicondyle (upper arms) and 15 cm below the medial epicondyle (lower arms) will be measured before treatment and every year through 10 years following the completion of radiotherapy at every time point

Number of patients with impaired shoulder movement (Range of motion of the shoulders)

Impaired shoulder movement is present when >20 degrees difference between arms at flexion and/or Abduction. Shoulder movement (Range of motion of the shoulders) will be assessed before treatment and every year through 10 years following the completion of radiotherapy

Number of patients with symptomatic rib fracture

Symptomatic rib fracture will be diagnosed by evidence of a correlative lesion on plain film or CT. It will be assessed before treatment and every year through 10 years following the completion of radiotherapy

Number of patients with brachial plexopathy

Brachial plexopathy will be documented if damage to the brachial plexus is suspected and patients have symptoms of pain, paresthesia, numbness, or other symptoms. Suspected cases of brachial plexopathy will be subject to confirmation by neurophysiological assessment. Brachial plexopathy will be assessed before treatment and every year through 10 years following the completion of radiotherapy

Number of patients with reconstruction complications

For patients received mastectomy and reconstruction, the following complications will be assessed before treatment and every year through 10 years following the completion of radiotherapy: capsular contraction, partial or entire flap necrosis or loss, implant leakage and rupture, implant exposure, infection, hematoma/seroma and secondary surgical intervention

Cosmetic outcomes for patients received mastectomy with reconstruction

The cosmetic outcomes will be evaluated by radiation oncologists, nurses and patients using digital photographs and Harvard/NSABP/RTOG Breast Cosmesis Grading Scale. Harvard/NSABP/RTOG Breast Cosmesis Grading Scale classifies the overall aesthetic results in four categories from excellent, good, fair to poor; comparing the reconstructed breast to the control breast. Excellent, there is minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast. The cosmetic outcomes will be assessed before treatment and every year through 10 years following the completion of radiotherapy. The breast cosmetic outcome will be measured by Harvard 4 scale (poor, fair, good, excellent) evaluation system

Quality of Life Life-EORTC QLQ-C30 (version 3)

Patients' quality of life will be assessed using self-administered questionnaire EORTC-QLQ-C30 (version 3) before treatment, the end of treatment, and every year through 10 years following the completion of radiotherapy

Quality of Life-EORTC breast-cancer module (BR23)

Patients' quality of life will be assessed using self-administered questionnaire EORTC breast-cancer module (BR23) before treatment, the end of treatment, and every year through 10 years following the completion of radiotherapy

Full Information

NCT ID

NCT03856372

First Posted

February 20, 2019

Last Updated

February 25, 2019

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03856372

Brief Title

Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer

Official Title

Postmastectomy Hypofractionated Versus Conventional Fractionated Radiotherapy in High Risk Breast Cancer: a Phase III Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

October 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study was designed to investigate whether hypofractionated adjuvant radiotherapy is noninferior to conventionally fractionated adjuvant radiotherapy in terms of efficacy and toxicities for high risk breast cancer patients treated with mastectomy

Detailed Description

The randomization is between 50 Gy / 25 fractions and 42.5 Gy/16 fractions, 5 fractions weekly. Eligible breast cancer patients with mastectomy and axillary dissection will be randomized 1:1 into two groups: conventional fractionated (CF) radiotherapy of 50 Gy / 25 fractions and hypofractionated (HF) radiotherapy of 42.5 Gy/16 fractions, 5 fractions weekly. The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late radiation morbidities will also be evaluated. The patients will be followed for 10 years. It is hypothesized that for women operated for high risk breast cancer with indication of postmastectomy adjuvant radiotherapy, hypofractionated radiotherapy is noninferior to conventional fractionated radiotherapy in terms of the efficacy and toxicities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Postmastectomy Hypofractionated Adjuvant Radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1494 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hypofractionated

Arm Type

Experimental

Arm Description

42.5 Gy / 16 fractions, 2.66 Gy per fraction, 5 fractions weekly

Arm Title

Conventional

Arm Type

Active Comparator

Arm Description

50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly

Intervention Type

Radiation

Intervention Name(s)

Hypofractionated

Other Intervention Name(s)

Experimental Arm

Intervention Description

daily fractions, five fractions per week.

Intervention Type

Radiation

Intervention Name(s)

Conventional

Other Intervention Name(s)

Standard Arm

Intervention Description

daily fractions, five fractions per week.

Primary Outcome Measure Information:

Title

Loco-regional recurrence (LRR)

Description

Time Frame

every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years

Secondary Outcome Measure Information:

Title

Distant metastasis free survival (DMFS)

Description

Time Frame

every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years

Title

Disease free survival (DFS)

Description

Time Frame

every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years

Title

Overall survival (OS)

Description

Time Frame

every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years

Title

CTCAE Toxicity Assessment-Acute toxicity

Description

Time Frame

before treatment, every week of treatment, the end of treatment, 2 weeks, 3 months after the last fraction received, every year through 10 years

Title

CTCAE Toxicity Assessment-Late toxicity

Description

Time Frame