Sodium Glycididazole Reduces the Adverse Reactions of Concurrent Chemoradiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sodium glycididazole.
- Who it may be relevant to
- Registry conditions: Chemoradiotherapy. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sodium Glycididazole Reduces Chemoradiotherapy-related Adverse Reactions During Concurrent Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer
Overview
To evaluate the efficacy and toxicity of sodium glycididazole combined with concurrent chemoradiotherapy in patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy.
Detailed description
1. To evaluate the efficacy and toxicity of concurrent chemoradiotherapy combined with sodium glycididazole in patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy, and to explore sodium glycididazole as a new way to inhibit the occurrence of radiation esophagitis and reduce the occurrence of radiation pneumonitis and lymphopenia. 2. To evaluate the sensitization effect of sodium glycididazole in the anti-tumor activity during concurrent chemoradiotherapy, as well as the changes in the anti-tumor immune response in peripheral blood, in order to screen out the dominant population and the predictive biomarkers with fewer related toxic and side effects. 3. By exploring the correlation between the expression level of NLRP3 inflammasome activation related molecules and imaging changes in peripheral blood after radiotherapy and the toxicity of radiotherapy and chemotherapy, a risk model for predicting radiation esophagitis after concurrent radiotherapy and chemotherapy for non-small cell lung cancer was further constructed.
Interventions
- Drug sodium glycididazole
Sodium glycididazole is intravenously infused at a dose of 800mg at 60 min before radiotherapy and used on Mondays, Wednesdays and Fridays during radiotherapy.
Primary outcome measures
- Incidence and severity of grade 3 and above radiation esophagitis [Time frame: 8 weeks]
- Incidence and severity of grade 2 and above radiation pneumonitis [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- Patients must have histologically or cytologically confirmed non-small cell lung cancer.
- Patients with unresectable stage II-III non-small cell lung cancer after neoadjuvant therapy.
- ECOG PS 0-2
- Adequate organ and bone marrow function.
Exclusion criteria
- History of previous radiotherapy.
- The previous immune-related pneumonitis ≥ grade 2.
- Local lesions require surgery.
- History of another primary malignancy.
- History of active primary immunodeficiency.
- Histological findings showed mixed small cell lung cancer and non-small cell lung cancer.
- For any unmitigated toxicity during pre-study chemoradiotherapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT06667622 · NCC4420