Evidence map›Paper›PMID 37923987›Full record

Trial reportBMC cancer2023

Preoperative sequential short-course radiation therapy and FOLFOX chemotherapy versus long-course chemoradiotherapy for locally advanced rectal cancer: a multicenter, randomized controlled trial (SOLAR trial).

Min Kyu Kang, Soo Yeun Park, Jun Seok Park, Hye Jin Kim, Jong Gwang Kim, Byung Woog Kang, Jin Ho Baek, Seung Hyun Cho, An Na Seo, Duck-Woo Kim and 10 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05673772 (A Multicenter, Randomized Controlled Trial of Preoperative Sequential Short-course Radiation Therapy and Oxaliplatin-based Consolidation Chemotherapy for Locally Advanced Rectal Cancer), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 20% of its field
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.

NCT05673772 phase2active not recruitingnot on this map

A Multicenter, Randomized Controlled Trial of Preoperative Sequential Short-course Radiation Therapy and Oxaliplatin-based Consolidation Chemotherapy for Locally Advanced Rectal Cancer

TypeinterventionalSponsorKyungpook National University HospitalRan2020 to 2031Enrolled364ConditionsRectal CancerArmsshort-course radiotherapy, mFOLFOX6, Chemoradiotherapy, TME surgery
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. 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

20 authors at 10 institutions in 1 country.

Min Kyu Kang *Department of Radiation Oncology, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, South Korea.
Soo Yeun Park *Colorectal Cancer Center, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, 807 Hogukro, Buk-gu, Daegu, 41404, South Korea.
Jun Seok ParkColorectal Cancer Center, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, 807 Hogukro, Buk-gu, Daegu, 41404, South Korea.
Hye Jin KimColorectal Cancer Center, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, 807 Hogukro, Buk-gu, Daegu, 41404, South Korea.
Jong Gwang KimDepartment of Oncology/Hematology, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, South Korea.
Byung Woog KangDepartment of Oncology/Hematology, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, South Korea.
Jin Ho BaekDepartment of Oncology/Hematology, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, South Korea.
Seung Hyun ChoDepartment of Radiology, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, South Korea.
An Na SeoDepartment of Pathology, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, South Korea.
Duck-Woo KimDepartment of Surgery, Seoul National University Bundang Hospital, Seongnam, South Korea.
Jin KimDivision of Colon and Rectal Surgery, Department of Surgery, Korea University College of Medicine, Seoul, South Korea.
Se Jin BaekDivision of Colon and Rectal Surgery, Department of Surgery, Korea University College of Medicine, Seoul, South Korea.
Ji Hoon KimDivision of Colorectal Surgery, Department of Surgery, Incheon St. Mary's Hospital, the Catholic University of Korea, Incheon, South Korea.
Ji Yeon KimDivision of Colorectal Surgery, Department of Surgery, Chungnam National University Hospital, Daejeon, South Korea.
Gi Won HaResearch Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, Jeonbuk, South Korea.
Eun Jung ParkDivision of Colon and Rectal Surgery, Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
In Ja ParkDivision of Colon and Rectal Surgery, Department of surgery, , University of Ulsan College of Medicine and Asan Medical Center, Seoul, South Korea.
Chang Hyun KimDepartment of Surgery, Chonnam National University Hwasun Hospital and Medical School, Hwasun, South Korea.
Hyun KangDepartment of Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul, South Korea.
Gyu-Seog ChoiColorectal Cancer Center, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, 807 Hogukro, Buk-gu, Daegu, 41404, South Korea. kyuschoi@knu.ac.kr.
Kyungpook National University Hospital · KRKorea University · KRThe Catholic University of Korea Incheon St. Mary's Hospital · KRChonnam National University Hwasun Hospital · KRChung-Ang University · KRChungnam National University Hospital · KRGangnam Severance Hospital · KRJeonbuk National University · KRSeoul National University Bundang Hospital · KRUniversity of Ulsan · KR

Funding

National R&D Program for Cancer Control through the National Cancer Center (NCC) funded by the Ministry of Health & Welfare, Republic of Korea HA22C0042
6 · The paper itself

Abstract

backgroundPreoperative (chemo)radiotherapy has been widely used as an effective treatment for locally advanced rectal cancer (LARC), leading to a significant reduction in pelvic recurrence rates. Because early administration of intensive chemotherapy for LARC has more advantages than adjuvant chemotherapy, total neoadjuvant therapy (TNT) has been introduced and evaluated to determine whether it can improve tumor response or treatment outcomes. This study aims to investigate whether short-course radiotherapy (SCRT) followed by intensive chemotherapy improves oncologic outcomes compared with traditional preoperative long-course chemoradiotherapy (CRT).

methodsA multicenter randomized phase II trial involving 364 patients with LARC (cT3-4, cN+, or presence of extramural vascular invasion) will be conducted. Patients will be randomly assigned to the experimental or control arm at a ratio of 1:1. Participants in the experimental arm will receive SCRT (25 Gy in 5 fractions, daily) followed by four cycles of FOLFOX (oxaliplatin, 5-fluorouracil, and folinic acid) as a neoadjuvant treatment, and those in the control arm will receive conventional radiotherapy (45-50.4 Gy in 25-28 fractions, 5 times a week) concurrently with capecitabine or 5-fluorouracil. As a mandatory surgical procedure, total mesorectal excision will be performed 2-5 weeks from the last cycle of chemotherapy in the experimental arm and 6-8 weeks after the last day of radiotherapy in the control arm. The primary endpoint is 3-year disease-free survival, and the secondary endpoints are tumor response, overall survival, toxicities, quality of life, and cost-effectiveness. DISCUSSION: This is the first Korean randomized controlled study comparing SCRT-based TNT with traditional preoperative LC-CRT for LARC. The involvement of experienced colorectal surgeons ensures high-quality surgical resection. SCRT followed by FOLFOX chemotherapy is expected to improve disease-free survival compared with CRT, with potential advantages in tumor response, quality of life, and cost-effectiveness.

trial registrationThis trial is registered at Clinical Research Information under the identifier Service KCT0004874 on April 02, 2020, and at Clinicaltrial.gov under the identifier NCT05673772 on January 06, 2023.

Indexed as

Neoadjuvant TherapyRectal NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapyFluorouracilHumansNeoplasm StagingQuality of LifeFluorouracilConsolidation chemotherapyDisease-free survivalNeoadjuvant radiotherapyProtocolRandomized controlled phase II trialRectal neoplasmShort-course radiation

Identifiers

PMID37923987
PMCPMC10623855
OpenAlexW4388293398

What OpenQuestion holds

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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.