Not yet recruiting NCT05922358

Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors

Phase II Interventional Gastrointestinal Tumors

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: Anti-allergic treatment.
Who it may be relevant to: Registry conditions: Gastrointestinal Tumors. Basic parameters: 18 years — 75 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: Center list to be confirmed — check the primary protocol.
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

Observation of Oxaliplatin Hypersensitivity and Neurotoxicity in GI Tract, and Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors: A Prospective, Open-Label, Multicenter, Phase II Study

Overview

The incidence of oxaliplatin allergy reactions is between 12-15%, while the incidence of severe (grade 3-4) allergic reactions is between 0.5-2%. The purpose of this study is to prospectively investigate the incidence of oxaliplatin allergy and neurotoxicity, and to evaluate the use of effective anti-allergic and desensitization therapies to enable patients who are already allergic to oxaliplatin to complete their prescribed doses smoothly.

Detailed description

Patients with GI receiving oxaliplatin-containing regimens were prospectively observed, and patients with oxaliplatin grade I-III hypersensitivity reactions judged by clinicians based on clinical symptoms and signs entered the oxaliplatin reuse study . For patients with grade I-III oxaliplatin allergy, oxaliplatin skin test with 3 concentration gradients (0.01 mg/ml, 0.1 mg/ml and 5 mg/ml) was performed, and 5% glucose Water served as a negative control. 15-20 minutes to read test results. If the largest diameter of the rash was greater than 3 mm of the negative control, it was judged as a positive result. Afterwards, interventions were performed in different ways according to the grade of oxaliplatin allergic reaction.

Interventions

Combination product Anti-allergic treatment
For grade I-III hypersensitivity to oxaliplatin, oxa 0.01 mg/ml, 0.1 mg/ml and 5 mg/ml were used in sequence for skin test. 5% GS was used as a negative control. Test results are read within 15 to 20 minutes. Grade IV: Permanently stop using oxaliplatin; Grade I-II: Take orally (cetirizine 10 mg bid, dexamethasone 8 mg bid, ranitidine 150 mg bid\*3dose) the day before the next cycle of oxaliplatin. The infusion rate is 50% of the original rate; if a grade II hypersensitivity reaction occurs aga

Primary outcome measures

Completion rate of 3 cycles of re-chemotherapy with oxaliplatin [Time frame: 2 years]

Secondary outcome measures (1)

Concordance rate between oxaliplatin skin test results and clinicians' judgment [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

Patients who plan to receive oxaliplatin treatment;
Male or female aged 18-75 year;
ECOG PS 0-2;
The expected survival time is more than 3 months;
Capable and willing to accept survey patients

Exclusion criteria

1.Patients who were not suitable for the enrollment of this study judged by the investigator

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

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05922358 · SYLT-027

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗