The goal of this clinical trial is to evaluate CBCT image-based triggered online adaptive radiotherapy (ART) and assess its clinical benefits in protecting organs at risk (OARs).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
All participants will receive intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT). To ensure study quality, all radiation therapy plans will undergo review by the research team at Sun Yat-sen University Cancer Center. Target volume delineation will adhere to the involved-site radiation therapy (ISRT) principles recommended by the International Lymphoma Radiation Oncology Group (ILROG) consensus guidelines. Treatment will be categorized based on intent: definitive radiation therapy or consolidative radiation therapy. The ART process primarily includes: imaging acquisition → AI-assisted automatic contouring → adaptive decision-making → plan optimization → verification → treatment delivery and documentation.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Proportion of patients successfully completing the full course of ART treatment
Defined as the proportion of patients who complete ≥90% of the planned fractions of the online ART process. This includes successful completion of online image evaluation, plan modification (if required), verification that the modified plan meets preset criteria (OARs dose constraints, PTV coverage ≥95%), dose verification, and successful treatment delivery. Cases where treatment is not completed due to technical failures causing delays \>60 minutes, or patient intolerance (e.g., vomiting/pain requiring interruption, or positional shifts \>5mm that cannot be corrected) are excluded from this success metric.
Time frame: End of ART
Objective Response Rate (ORR)
Defined as the sum of patients achieving Complete Response (CR) and Partial Response (PR) according to the 2014 Lugano Classification for response assessment, divided by the number of patients in the analysis set. That is, ORR = (CR + PR) / Number of patients in the analysis set. Response assessment is performed 3 months after the last fraction of radiotherapy, categorized as either radiographic response (assessed by CT/MRI) and/or metabolic response (assessed by PET/CT).
Time frame: Imaging assessment at approximately 12 weeks (3months) after completion of radiotherapy
1-year Progression-Free Survival (PFS) Rate
PFS is defined as the time from the day of first study drug administration to tumor progression (in any aspect) or death (from any cause).
Time frame: At 12 months post-radiotherapy
1-year Overall Survival (OS) Rate
OS is defined as the time from Day 1 of treatment to death from any cause.
Time frame: At 12 months post-radiotherapy
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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Throughout this study and during the follow-up period, the proportion of patients experiencing ≥Grade 2 radiotherapy-related toxicities (per CTCAE v5.0). Acute phase: From Day 1 of radiotherapy to 3 months post-treatment. Late phase: From 3 months to 1 year post-radiotherapy. Late toxicities include but are not limited to gastrointestinal events (e.g., gastric ulcer, hemorrhage, stenosis), hepatic toxicity, or other organ toxicities.
Time frame: From the first day of radiation therapy initiation to within 3 months, 6 months, and 12 months after completion.
Quality of Life (QoL)
The QoL was assessed at baseline and during follow-up using the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30), Version 3.0, which represent functions, symptoms, or health conditions. The EORTC QLQ-C30: a quality of life instrument for use in international clinical trials in oncology. A total of 30 items are included. Each item is graded from 1 to 4, except for items 29 and 30, indicating not at all, a little, quite a bit, and very much, with higher scores indicating poorer quality of life.
Time frame: Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy
EORTC Quality of Life Questionnaire-Gastric Cancer Module
The QoL STO22 was assessed at baseline and during follow-up using the EORTC Quality of Life Questionnaire-Gastric Cancer Module (QLQ-STO22). The EORTC QLQ-STO22: a quality of life instrument for use in international clinical trials in gastric cancer. A total of 22 items are included. Each item is graded from 1 to 4, indicating not at all, a little, quite a bit, and very much, with higher scores indicating poorer quality of life.
Time frame: Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy
Patient-Reported Quality of Life (PRO-QoL) Deterioration Rate
Defined as the assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTCQLQ-C30), from baseline to 1 month post-radiotherapy completion.
Time frame: Baseline and 1 month post-radiotherapy
Average duration per online ART session (from CBCT start to beam-on)
Time frame: Periprocedural of ART
Evaluation of actual target coverage throughout the entire treatment (assessed as the fraction of treatment sessions where PTV D95% ≥ 95% of the prescribed dose)
Time frame: From the first treatment session through the end of ART, an average of 4 weeks