Sodium Glycididazole Reduces the Adverse Reactions of Concurrent Chemoradiotherapy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

History of previous radiotherapy.

The previous immune-related pneumonitis ≥ grade 2.

Local lesions require surgery.

History of another primary malignancy.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Sodium glycididazole combined with concurrent chemoradiotherapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
8 weeks
2

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.

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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