Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: hypersensitivity group Corresponding intervention measures are given for different levels of hypersensitivity reactions |
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 again, the treatment method is the same as that of a grade III hypersensitivity reaction.
Grade III: Oral drugs are the same as above. 0.5h before oxaliplatin: dexamethasone 10mg iv, cimetidine 40mg iv, promethazine 25mg im. The first bag of 10% total amount of oxaliplatin + 5% GS500ml: 5ml/h*1h, 45ml/h*1h, then 225ml/h*2 hours; then dexamethasone 10mg iv; the second bag of 90% total Oxa +5%GS500ml: 100ml/h*0.5h, then 150ml/h*3 hours.
|
Outcome Measures
Primary Outcome Measures
- Completion rate of 3 cycles of re-chemotherapy with oxaliplatin [2 years]
Completion rate of 3 cycles of re-chemotherapy with oxaliplatin
Secondary Outcome Measures
- Concordance rate between oxaliplatin skin test results and clinicians' judgment [2 years]
Concordance rate between oxaliplatin skin test results and clinicians' judgment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who plan to receive oxaliplatin treatment;
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Male or female aged 18-75 year;
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ECOG PS 0-2;
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The expected survival time is more than 3 months;
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fujian Cancer Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SYLT-027