Sodium Glycididazole Reduces the Adverse Reactions of Concurrent Chemoradiotherapy

NCT06667622 | Recruiting Phase 2

• 1 other identifier: NCC4420
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of grade 3 and above radiation esophagitis

  Radiation esophagitis of grade 3 or higher is graded according to the toxicity criteria of the CTCAE v5.0.

  8 weeks

• Incidence and severity of grade 2 and above radiation pneumonitis

  Radiation pneumonitis of grade 2 or higher is graded according to the toxicity criteria of the CTCAE v5.0.

  8 weeks

Study Arms (1)

Sodium glycididazole combined with concurrent chemoradiotherapy group

EXPERIMENTAL

Patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy are treated with sodium glycididazole during concurrent chemoradiotherapy.

Drug: sodium glycididazole

Interventions

sodium glycididazole DRUG

Sodium glycididazole is intravenously infused at a dose of 800mg at 60 min before radiotherapy and used on Mondays, Wednesdays and Fridays during radiotherapy.

Also known as: Sodium glycididazole combined with concurrent chemoradiotherapy

Sodium glycididazole combined with concurrent chemoradiotherapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

sodium glycididazole; Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Lei Deng, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Lei Deng, MD

CONTACT

010-87787692; dengleipumc@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: October 31, 2024
• Study Start: May 29, 2024
• Primary Completion: January 10, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: October 31, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)