Evidence map›Paper›PMID 38854732›Full record

ArticleFrontiers in oncology2024

Stereotactic central/core ablative radiation therapy: results of a phase I study of a novel strategy to treat bulky tumor.

Jun Yang, Qiuxia Lu, Weihua Qi, Ryann D Kolb, Lei Wang, Yuan Li, Sida Li, Yihui Lin, Jiayi Liu, Waleed Mourad and 8 more

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06987370 (A Phase II Randomized Controlled Clinical Study on the Efficacy and Safety Evaluation of Radiotherapy Mode Based on SFRT and SCART Technologies for Bone Metastatic Malignant Tumors With Soft Tissue Formation), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–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.

NCT06987370 narecruitingnot on this mapstarted 2025, after this paper: background citation

A Phase II Randomized Controlled Clinical Study on the Efficacy and Safety Evaluation of Radiotherapy Mode Based on SFRT and SCART Technologies for Bone Metastatic Malignant Tumors With Soft Tissue Formation

TypeinterventionalSponsorShandong Cancer Hospital and InstituteRan2025 to 2027Enrolled90ConditionsBone Metastases in Subjects With Advanced CancerArmsConventional Radiotherapy (CRT), SCART (Stereotactic Central Ablative Radiation Therapy ) /SFRT(Spatially Fractionated Radiation Therapy )
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

18 authors.

Jun YangDepartmentof Radiation Oncology, Junxin Oncology Group, Foshan, China.
Qiuxia LuDepartmentof Radiation Oncology, Junxin Oncology Group, Foshan, China.
Weihua QiDepartmentof Radiation Oncology, Junxin Oncology Group, Foshan, China.
Ryann D KolbDepartment of Statistics, Virginia Tech, Blacksburg, VA, United States.
Lei WangDepartmentof Radiation Oncology, Junxin Oncology Group, Foshan, China.
Yuan LiDepartmentof Radiation Oncology, Junxin Oncology Group, Foshan, China.
Sida LiDepartmentof Radiation Oncology, Junxin Oncology Group, Foshan, China.
Yihui LinTaichung Veterans General Hospital, Department of Radiation Oncology, Taichung, Taiwan.
Jiayi LiuDepartment of Radiation Oncology, University of Pennsylvania, Philadelphia, PA, United States.
Waleed MouradDepartment of Radiation Medicine, Markey Cancer Center - UK Chandler Medical Center, Lexington, KY, United States.
Farzaneh MirkhaghaniHaghighiCameroon Oncology Center, Douala, Cameroon.
Tubin SlavisaMedaustron Center for Ion Therapy, Wiener Neustadt, Austria.
Xiaodong WuDepartment of Radiation Oncology, Executive Medical Physics Associates, Miami, FL, United States.
Wei-Ciang YouTaichung Veterans General Hospital, Department of Radiation Oncology, Taichung, Taiwan.
Eddy YangDepartment of Radiation Medicine, Markey Cancer Center - UK Chandler Medical Center, Lexington, KY, United States.
Alex HanlonDepartment of Statistics, Virginia Tech, Blacksburg, VA, United States.
Alan ZhuMayo Clinic Alix School of Medicine, Scottsdale, AZ, United States.
Weisi YanDepartment of Radiation Medicine, Markey Cancer Center - UK Chandler Medical Center, Lexington, KY, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Bulky tumor remains as a challenge to surgery, chemotherapy and conventional radiation therapy. Hence, in efforts to overcome this challenge, we designed a novel therapeutic paradigm via strategy of Stereotactic Central/Core Ablative Radiation Therapy (SCART).), which is based on the principles of SBRT (stereotactic body radiation therapy and spatially fractionated radiation therapy (SFRT). We intend to safely deliver an ablative dose to the core of the tumor and with a low dose at tumor edge. The purpose of the phase 1 study was to determine dose-limiting toxicities (DLT)s and the Maximum Tolerated Dose (MTD) of SCART. Methods and materials: We defined a SCART-plan volume inside the tumor, which is proportional to the dimension of tumor. VMAT/Cyberknife technique was adopted. In the current clinical trial; Patients with biopsy proven recurrent or metastatic bulky cancers were enrolled. The five dose levels were 15 Gy X1, 15Gy X3, 18GyX3, 21GyX3 and 24GyX3, while keeping the whole tumor GTV's border dose at 5Gy each fraction. There was no restriction on concurrent systemic chemotherapy agents. Results: 21 patients were enrolled and underwent SCART. All 21 patients have eligible data for study follow-up. Radiotherapy was well tolerated with all treatment completed as scheduled. The dose was escalated for two patients to 24GyX3. No grade 3 or higher toxicity was observed in any of the enrolled patients. The average age of patients was 66 years (range: 14 Conclusion: SCART was safely escalated to 24 GyX 3 fractions, which is the maximum Tolerated Dose (MTD) for SCART. This regimen will be used in future phase II trials.

Indexed as

bulky tumorphase 1ROB-D-23-00930 clinical investigation -Other SFRTSBRTSCART

Identifiers

PMID38854732
PMCPMC11157688

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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.