Evidence map›Paper›PMID 38802888›Full record

ArticleRadiation oncology (London, England)2024

Hypofractionated radiotherapy with simultaneous tumor bed boost (Hi-RISE) in breast cancer patients receiving upfront breast-conserving surgery: study protocol for a phase III randomized controlled trial.

Kairui Jin, Jurui Luo, Xiaoli Yu, Xiaomao Guo

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Radiation oncology (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04025164 (Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery:a Multi-center Phase III Randomized Clinical Trial), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04025164 narecruitingnot on this map

Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery:a Multi-center Phase III Randomized Clinical Trial

TypeinterventionalSponsorFudan UniversityRan2018 to 2028Enrolled4,052ConditionsBreast CancerArmsHypofractionated Radiotherapy, Conventional fractionated Radiotherapy
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Kairui Jin *Department of Radiation Oncology, Department of Oncology, Shanghai Medical College, Shanghai Clinical Research Center for Radiation Oncology, Shanghai Key Laboratory of Radiation Oncology, Fudan University Shanghai Cancer Center, Fudan University, 270 DongAn Road, Shanghai, 200032, China.
Jurui Luo *Department of Radiation Oncology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200127, China.
Xiaoli YuDepartment of Radiation Oncology, Department of Oncology, Shanghai Medical College, Shanghai Clinical Research Center for Radiation Oncology, Shanghai Key Laboratory of Radiation Oncology, Fudan University Shanghai Cancer Center, Fudan University, 270 DongAn Road, Shanghai, 200032, China. stephanieyxl@hotmail.com.
Xiaomao GuoDepartment of Radiation Oncology, Department of Oncology, Shanghai Medical College, Shanghai Clinical Research Center for Radiation Oncology, Shanghai Key Laboratory of Radiation Oncology, Fudan University Shanghai Cancer Center, Fudan University, 270 DongAn Road, Shanghai, 200032, China. guoxm1800@163.com.

Funding

National Natural Science Foundation of China 8197110875
6 · The paper itself

Abstract

backgroundThe effectiveness and safety of moderately hypofractionated radiotherapy (HFRT) in patients undergoing breast-conserving surgery (BCS) has been demonstrated in several pivotal randomized trials. However, the feasibility of applying simultaneous integrated boost (SIB) to the tumor bed and regional node irradiation (RNI) using modern radiotherapy techniques with HFRT needs further evaluation.

methodsThis prospective, multi-center, randomized controlled, non-inferiority phase III trial aims to determine the non-inferiority of HFRT combined with SIB (HFRTsib) compared with conventional fractionated radiotherapy with sequential boost (CFRTseq) in terms of five-year locoregional control rate in breast cancer patients undergoing upfront BCS. A total of 2904 participants will be recruited and randomized in a 1:1 ratio into the HFRTsib and CFRTseq groups. All patients will receive whole breast irradiation, and those with positive axillary nodes will receive additional RNI, including internal mammary irradiation. The prescribed dose for the HFRTsib group will be 40 Gy in 15 fractions, combined with a SIB of 48 Gy in 15 fractions to the tumor bed. The CFRTseq group will receive 50 Gy in 25 fractions, with a sequential boost of 10 Gy in 5 fractions to the tumor bed. DISCUSSION: This trial intends to assess the effectiveness and safety of SIB combined with HFRT in early breast cancer patients following BCS. The primary endpoint is locoregional control, and the results of this trial are expected to offer crucial evidence for utilizing HFRT in breast cancer patients after BCS.

trial registrationThis trial was registered at ClincalTrials.gov (NCT04025164) on July 18, 2019.

Indexed as

Breast NeoplasmsMastectomy, SegmentalRadiation Dose HypofractionationAdultAgedClinical Trials, Phase III as TopicEquivalence Trials as TopicFemaleHumansMiddle AgedMulticenter Studies as TopicProspective StudiesRadiotherapy, AdjuvantRadiotherapy, Intensity-ModulatedRandomized Controlled Trials as TopicYoung AdultBreast cancerHypofractionated radiotherapyRandomized controlled trialRegional node irradiationSimutaneous integrated boost

Identifiers

PMID38802888
PMCPMC11131299

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.