The Effects of RFA in Combination With Second-line Chemotherapy and Bevacizumab on Unresectable CRLM

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT03686254
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Colorectal Neoplasms Malignant

Eligibility Criteria

Sex
ALL
Age
16 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • RFA, bevacizumab and second-line chemotherapy — COMBINATION_PRODUCT
    Navigated by CT-ultrasound merged images, RFA is taken in the experimental arm at the first day of the first cycle during the second-line therapy. Bevacizumab is given to patients in all arms every 2 weeks (5mg/kg) or 3 weeks (7.5mg/kg), intravenous drip(VD). The second-line chemotherapies include FOLFIRI \[Irinotecan 180 mg/m2 D1+Calcium folinatc 400 mg/m2 or Calcium Levofolinate 200 mg/m2 D1+5-FU 400 mg/m2 D1, 2400 mg/m2 D1-2(46-48h), q2W\] or irinotecan monotherapy (125 mg/m2 D1, 8, q3W or 180 mg/m2 D1, q2W), mFOLFOX6 \[Oxaliplatin 85 mg/m2 D1+Calcium folinatc 400 mg/m2 or Calcium Levofolinate 200 mg/m2 D1+5-FU 400 mg/m2 D1, 2400 mg/m2 D1-2(46-48h), q2W\] or CapeOX (Oxaliplatin 130 mg/m2 D1+Capecitabine 1000 mg/m2 Bid D1-14, q3W)，or irinotecan+oxaliplatin (Oxaliplatin 85 mg/m2 D1+Irinotecan 200 mg/m2 D1, q3W). Among these strategies, the treatment cycle of FOLFIRI, irinotecan monotherapy and mFOLFOX6 is two weeks, while three weeks in CapeOX and irinotecan + oxaliplatin.
  • Bevacizumab and second-line chemotherapy — DRUG
    Bevacizumab is given to patients in all arms every 2 weeks (5mg/kg) or 3 weeks (7.5mg/kg), intravenous drip(VD). The second-line chemotherapies include FOLFIRI \[Irinotecan 180 mg/m2 D1+Calcium folinatc 400 mg/m2 or Calcium Levofolinate 200 mg/m2 D1+5-FU 400 mg/m2 D1, 2400 mg/m2 D1-2(46-48h), q2W\] or irinotecan monotherapy (125 mg/m2 D1, 8, q3W or 180 mg/m2 D1, q2W), mFOLFOX6 \[Oxaliplatin 85 mg/m2 D1+Calcium folinatc 400 mg/m2 or Calcium Levofolinate 200 mg/m2 D1+5-FU 400 mg/m2 D1, 2400 mg/m2 D1-2(46-48h), q2W\] or CapeOX (Oxaliplatin 130 mg/m2 D1+Capecitabine 1000 mg/m2 Bid D1-14, q3W)，or irinotecan+oxaliplatin (Oxaliplatin 85 mg/m2 D1+Irinotecan 200 mg/m2 D1, q3W). Among these strategies, the treatment cycle of FOLFIRI, irinotecan monotherapy and mFOLFOX6 is two weeks, while three weeks in CapeOX and irinotecan + oxaliplatin.

Study Details

Basing on the strong evidence from former researches, patients with CRLM can benefit from the treatment of bevacizumab combined with sencond-line chemotherapy. Recently, although with the popularization of RFA, the role that RFA plays in the long term survival of patients with metastatic colorectal cancer (CRC) is still confused. In this designed, randomized, controlled, prospective, and open clinical trial, the effectiveness of RFA combined with second-line chemotherapy + bevacizumab on unresectable CRLM is going to be evaluated compared with that of second-line chemotherapy + bevacizumab. After screened by inclusion and exclusion criteria, the eligible subjects will be randomly allocated into the experimental group-with the treatment of RFA + second-line chemotherapy + bevacizumab and control group-with the treatment of second-line chemotherapy + bevacizumab equally.

Key Dates

First listed
Sep 26, 2018
Start date
Jul 16, 2018
Status verified
Sep 2018
Primary completion
Oct 1, 2023
Completion
Oct 1, 2023

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: The control Arm
    bevacizumab and second-line chemotherapy
  • Experimental: The experimental Arm
    RFA, bevacizumab and second-line chemotherapy

Primary Outcome Measure

Overall survival (OS), Month [ Time Frame: From the date of randomization until the date of death due to any cause, assessed up to 36 months ]

Central Contacts

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