Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery - Full Text View

Purpose

Early-stage breast cancer patients treated with breast conservative surgery are enrolled in this study if they meet defined criteria. Patients are randomized into two groups: conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar efficacy and toxicity.

Condition	Intervention	Phase
Breast Cancer	Radiation: radiotherapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients After Breast Conservative Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:

in-breast recurrence rate [ Time Frame: 5 year ] [ Designated as safety issue: No ]
evidence of ipsilateral breast local recurrence confirmed by histology

Secondary Outcome Measures:

regional node recurrence rate [ Time Frame: 5 year ] [ Designated as safety issue: No ]
ipsilater axillary node, internal mammary node and supraclavicular node recurrence confirmed by physical examinztion,image evaluation or histology.
disease-free survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
acute toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
radiation dermititis and radiation pneumonitis evaluated and graded by CTC3.0 criteria
late complication [ Time Frame: 3 -10 year ] [ Designated as safety issue: Yes ]
breast cosmetic effect, ischemic heart disease, rib fracture, arm edema and shoulder joint dysfunction

Estimated Enrollment:	630
Study Start Date:	June 2010
Estimated Study Completion Date:	June 2019
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: hypofractionation radiotherapy irradiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.	Radiation: radiotherapy one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week. the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.
Active Comparator: conventional fractionation radiotherapy irradiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.	Radiation: radiotherapy one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week. the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.

Arms

Assigned Interventions

Experimental: hypofractionation radiotherapy

irradiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.

Radiation: radiotherapy

one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.

the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.

Active Comparator: conventional fractionation radiotherapy

irradiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.

Radiation: radiotherapy

one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.

the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

KPS>=60
histology confirmed invasive breast cancer
received breast conservative surgery(wide local excision and axilla dissection, or axillary sentinel node biopsy if sentinel node is negative)
surgical margins negative
primary tumor ≤5cm in the largest diameter
no internal mammary node or supraclavicular node metastases or distant metastasis
can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy
for patients not need chemotherapy，enrollment date is required no more than 8 weeks from surgery date
for patients with chemotherapy first,enrollment date is required no more than 8 weeks from the last date of chemotherapy
patients signed written inform consent form

Exclusion Criteria:

ductal carcinoma in situ
prior neoadjuvant chemotherapy
prior breast cancer history
bilateral breast cancer
pregnant or during lactation
prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and cervix carcinoma in situ
active collagen vascular disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413269

Locations

China
Cancer Hospital, Chinese Academy of Medical Sciences	Recruiting
Beijing, China, 100021
Contact: shu-lian Wang, M.D. 10-87787625 wsl20040118@yahoo.com
Contact: ye-xiong Li, M.D. 10-87788860 yexiong@yahoo.com
Principal Investigator: Shu-lian Wang, M.D.

Sponsors and Collaborators

Chinese Academy of Medical Sciences

Investigators

Study Chair:	ye-xiong Li, M.D.	Cancer Hospital, Chinese Academy of Medical Sciences
Principal Investigator:	Shu-lian Wang, M.D.	Cancer Hospital, Chinese Academy of Medical Sciences

More Information

No publications provided

Responsible Party:	Shu lian Wang, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:	NCT01413269 History of Changes
Other Study ID Numbers:	CH-BC-013
Study First Received:	August 9, 2011
Last Updated:	February 13, 2012
Health Authority:	China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:

breast cancer patients
breast conservation surgery
hypofractionated radiotherapy

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013