Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors

NCT ID: NCT05922358

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-09-01

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.

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.

Conditions

Gastrointestinal Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hypersensitivity group

Corresponding intervention measures are given for different levels of hypersensitivity reactions

Group Type: EXPERIMENTAL

Anti-allergic treatment

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SYLT-027

Identifier Type: -

Identifier Source: org_study_id