Rate of recurrent neutropenia between the omitted of bolus dose of fluorouracil group compare with the oxaliplatin dose reduction group in colorectal cancer patients, a randomized cross-over trial

Phase 3

Recruiting

• Conditions: stage III colon cancer patients who received an adjuvant chemotherapy, stage IV colon cancer patients or stage IV rectal cancer patients who received a first line palliative chemotherapy; dose reduction or dose modification or dose adjustment, neutropenia, colon cancer, FOLFOX, relative dose intensity

• Registration Number: TCTR20190909001
• Lead Sponsor: &#45

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-09
• Study Completion: 2020-05-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. An age is greater than or equal to 18
2. histologically confirmed AJCC/UICC stage III or IV adenocarcinoma colon cancer
3. histologically confirmed AJCC/UICC stage IV adenocarcinoma rectal cancer
4. history of neutropenia (absolute neutrophils count < 1,500) from previous chemotherapy (FOLFOX4 or FOLFOL6 regimen)
5. adequate organ function
6. ECOG performance status 0 to 1
7. signed written informed consent obtained prior to any study specific procedures

Exclusion Criteria

1. eGFR less than 15
2. abnormal liver function test
3. other malignancies within the last 5 years
4. history of clinically relevant psychritic disability
5. previous radiotherapy within the last 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of recurrent neutropenia within 2 cycles of chemotherapy (mFOLFOX6 regimen) rate

Secondary Outcome Measures

Name	Time	Method
delay time for next chemotherapy cycle, absolute neutrophil, rate of grade 3-5 adverse event count, within 2 cycles of chemotherapy (mFOLFOX6 regimen) mean