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Trial Title:
Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors
NCT ID:
NCT05922358
Condition:
Gastrointestinal Tumors
Conditions: Official terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms
Hypersensitivity
Anti-Allergic Agents
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Anti-allergic treatment
Description:
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.
Arm group label:
hypersensitivity group
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients who plan to receive oxaliplatin treatment;
2. Male or female aged 18-75 year;
3. ECOG PS 0-2;
4. The expected survival time is more than 3 months;
5. 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
September 1, 2023
Completion date:
September 1, 2026
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05922358
