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Hypofractionated Irradiation At Regional Nodal Area for Breast Cancer Vs Existed Standard Treatment

Study acronym: HARVEST
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 2, 2022 (before its estimated December 2022 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 2023 to Dec 2022 Completion date: Dec 2028 to Dec 2027 · Eligibility criteria shortened, about 33 words · Secondary endpoints: 6 to 7v6 Show 3 more changesShow less
    • Completion date: Dec 2028 to Dec 2027
    • Eligibility criteria shortened, about 33 words
    • Secondary endpoints: 6 to 7

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria shortened, about 6 wordsv5 See this version in full on ClinicalTrials.gov ↗
  3. Eligibility criteria shortened, about 13 words Collaborators: 5 to 8v4 Show 1 more changeShow less
    • Collaborators: 5 to 8

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 2019 to Feb 21, 2019 · Site details revised · Eligibility criteria shortened, about 5 wordsv3 Show 3 more changesShow less
    • Start date changed from estimate of Feb 2019 to Feb 21, 2019
    • Site details revised
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  5. Secondary endpoints: details revised at 1 of 6 entriesv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ruijin Hospital
370 trials monitored
See 13 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
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.
Trial Details
NCT Number NCT03829553
Lead Sponsor Ruijin Hospital
Collaborators: RenJi Hospital, Shanghai 10th People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Zhongshan Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Affiliated Hospital of Jiangnan University, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Conditions Breast Cancer
Enrollment 801 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov