Evidence map›Paper›PMID 41405883›Full record

Trial reportJAMA network open2025

Five-Day Preoperative Radiation Therapy for Patients With High-Risk Soft Tissue Sarcoma: A Nonrandomized Clinical Trial.

John Nikitas, Joseph K Kendal, Ricky R Savjani, Nicholas Jackson, Nicholas Peterson, Jie Deng, Jackie Hernandez, Natalie Chong, Arun S Singh, Bartosz Chmielowski and 13 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA network open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02701153 (Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT02701153 narecruitingnot on this map

Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

TypeinterventionalSponsorJonsson Comprehensive Cancer CenterRan2016 to 2028Enrolled51ConditionsRecurrent Adult Soft Tissue SarcomaArmsConventional Surgery, Hypofractionated Radiation Therapy, Laboratory Biomarker Analysis, Questionnaire Administration
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. 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

23 authors.

John NikitasDepartment of Radiation Oncology, University of California, Los Angeles.
Joseph K KendalDepartment of Surgery, University of Calgary, Calgary, Alberta, Canada.
Ricky R SavjaniDepartment of Radiation Oncology, University of California, Los Angeles.
Nicholas JacksonDepartment of Medicine Statistics Core, University of California, Los Angeles.
Nicholas PetersonDepartment of Radiation Oncology, University of California, Irvine.
Jie DengDepartment of Radiation Oncology, University of California, Los Angeles.
Jackie HernandezDepartment of Radiation Oncology, University of California, Los Angeles.
Natalie ChongDepartment of Radiation Oncology, University of California, Los Angeles.
Arun S SinghDivision of Hematology-Oncology, Department of Medicine, University of California, Los Angeles.
Bartosz ChmielowskiDivision of Hematology-Oncology, Department of Medicine, University of California, Los Angeles.
Noah C FedermanDepartment of Pediatrics, University of California, Los Angeles.
Joseph G CromptonDivision of Surgical Oncology, University of California, Los Angeles.
Brian E KaderaDivision of Surgical Oncology, University of California, Los Angeles.
Lauren E WesselDivision of Surgical Oncology, University of California, Los Angeles.
Alexander B ChristDivision of Surgical Oncology, University of California, Los Angeles.
Scott D NelsonDepartment of Pathology and Laboratory Medicine, University of California, Los Angeles.
Sarah M DryDepartment of Pathology and Laboratory Medicine, University of California, Los Angeles.
Joanne B WeidhaasDepartment of Radiation Oncology, University of California, Los Angeles.
Michael L SteinbergDepartment of Radiation Oncology, University of California, Los Angeles.
Nicholas M BernthalDepartment of Orthopedic Surgery, University of California, Los Angeles.
Fritz C EilberDivision of Surgical Oncology, University of California, Los Angeles.
Anusha KalbasiDepartment of Radiation Oncology, Stanford Cancer Institute, Stanford University School of Medicine, Stanford, California.
Vishruth K ReddyDepartment of Radiation Oncology, University of California, Los Angeles.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: Standard preoperative radiotherapy (RT) for high-risk soft tissue sarcoma (STS) is delivered over 5 weeks, which can be a logistical challenge for patients. Objective: To evaluate the long-term toxic effects and clinical outcomes associated with a shorter 5-day, dose-equivalent preoperative RT regimen. Design, Setting, and Participants: Phase 2, single-group nonrandomized trial with an initial cohort (April 2016 to May 2018) and expansion cohort (October 2018 to May 2023) at a single academic center in the US. Participants were patients with histologically confirmed extremity or trunk STS recommended to undergo standard preoperative RT and surgery. Patients with planned neoadjuvant systemic therapy who were enrolled in the expansion group were excluded from this analysis. Analysis was conducted September 2024 to August 2025. Intervention: A total of 30 Gy in 5 fractions were delivered preoperatively. Main Outcomes and Measures: The primary end point was 2-year grade 2 or higher radiation toxic effects. Secondary end points included major wound complications (MWC), local failure, distant progression, and overall survival. Results: A total of 110 patients were treated with preoperative RT and surgery (42 patients [38%] were aged 65-79 years; 64 [58%] were male; 75 had tumors of the lower extremity [68%], and 64 patients [58%] had high-grade disease). The initial cohort accrued 50 patients who underwent surgery. The expansion cohort accrued 83 patients; 60 of 83 were treated without neoadjuvant chemotherapy and were included. Median (IQR) follow-up was 37.3 (20.1-60.6) months, including 64.2 (36.3-74.1) months for the initial cohort and 30.0 (13.5-40.2) months for the expansion cohort. At 2 years, 14 of 74 evaluable patients (18.9%) developed grade 2 or higher toxic effects (10 patients [25.0%] for the initial cohort and 4 patients [11.8%] for the expansion cohort). MWCs occurred in 33 of 110 patients (30.0%); (17 [34.0%] for the initial cohort and 16 [26.7%] for the expansion cohort). Time to wound closure exceeded 6 months for 15 patients (13.6%), including 12 of 29 patients (41.4%) who underwent local tissue advancement flaps. Two-year local control adjusting for competing risk of death was 92.4% (95% CI, 86.3%-96.5%). There were 3 (2.7%) bone fractures and 5 (4.5%) amputations. Conclusions and Relevance: This nonrandomized clinical trial of ultrahypofractionated preoperative RT identified durable local control with MWC and favorable late grade 2 or higher toxic effects rates. Randomized data are necessary to differentiate the safety profiles of various fractionation regimens, especially duration of wound healing. Trial Registration: ClinicalTrials.gov Identifier: NCT02701153.

Indexed as

Preoperative CareSarcomaAgedFemaleHumansMaleMiddle AgedNeoadjuvant TherapyTreatment Outcome

Identifiers

PMID41405883
PMCPMC12712729

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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.