NCT Number: NCT03829553
The main objective of this trial is to investigate the efficacy and safety of hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of 5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients with an indication for regional nodal irradiation (RNI) following mastectomy or breast conserving surgery. Patients will be randomized to hypofractionated radiotherapy or conventional radiotherapy delivered to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). Eligible breast cancer patients will be followed for at least 5 years to evaluate the difference in 5-year locoregional recurrence, over survival, distant metastasis, toxicity and life quality between two groups.
Interested in participating?
Request Info18 year–75 year
Female
Interventional
Phase 3
Shanghai, Shanghai Municipality, 200025, China
Location status: Recruiting
Jia-Yi Chen, M.D
CONTACT
+86-021-64370045 ext. 602400
Jia-Yi Chen, M.D.
CONTACT
+86-021-64370045 ext. 602400
Investigators hypothesize that hypofractionated radiotherapy is equally effective and safe as conventional radiotherapy in breast cancer patients with an indication for regional nodal irradiation. Eligible breast cancer patients are randomized 1:1 into the following two groups: hypofractionated radiotherapy of 2.67 Gy for 16 fractions (and sequential tumor bed boost of 2.67 Gy for 4 fractions in patients with intact breast) and conventional radiotherapy of 2Gy for 25 fractions (and sequential tumor bed boost of 2 Gy for 5 fractions in patients with intact breast). The dose was prescribed to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). All patients are treated with IMRT. The primary endpoint is locoregional recurrence. Patients will be followed at least 5 years after radiotherapy to evaluated over survival, distant metastasis, toxicity and life quality.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Notes for exlusion criteria:
4005 cGy/ 15 fractions / 3 weeks to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67Gy for 4 fractions in patients with intact breast
Other names: Experimental Arm
5000 cGy/ 25 fractions / 5 weeks ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2Gy for 5 fractions in patients with intact breast
Other names: Active Comparator Arm
Time frame: 5 years
any first recurrence confirmed by histology or cytology in the ipsilateral chest wall or breast or regional nodes areas (including axillary, supraclavicular, infraclavicular lymph nodes or IMN)
Time frame: 5 years
the time from the date of randomization to any recurrence of tumor at distant sites or death from any cause.
Time frame: 5 year
the time from the date of randomization to any invasive recurrence of tumor, distant metastases or death from any cause and second invasive primaries, including invasive neoplasms of the breast.
Time frame: 5 years
the time from the date of randomization to the date of death from any cause or end of the follow-up.
Time frame: 5 years
The time from the date of randomization to 5 years after completion of radiotherapy, the cosmetic outcomes will be evaluated before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/(National Surgical Adjuvant Breast and Bowel Project) NSABP/ (Radiation Therapy Oncology Group) RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a 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.
Time frame: 6 months
within time from beginning of RT to 6 months after completion of RT assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time frame: 5 years
within time from 6 months after completion of RT to 5 years after completion of RT assessed according to the RTOG/ European Organization for Research on Treatment of Cancer (EORTC） Late Radiation Morbidity Scoring Schema and CTCAE version 3.0
Time frame: 5 years
number of participants with any reconstruction complications (flap necrosis, capsular contracture, infection, loss of implant/expander or flaps, et al) and the interval between the RT and reconstruction complications will be recorded. Patient reported outcome with reconstruction will be evaluated by Breast-Q questionnaires before RT and 12 months after RT.
Time frame: 1 years
The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-C30
Time frame: 5 years
The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-C30
Time frame: 1 years
The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-BR23
Time frame: 5 years
The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-BR23
Contact information is provided by the study sponsor or research team.
Ruijin Hospital
Other
Hypofractionated Versus Conventional Intensity-Modulated Radiation Therapy for Breast Cancer Patients With an Indication for Regional Nodal Irradiation: A Randomized Multi-center Phase III Trial
Acronym: HARVEST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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