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RALOX or CAPOX + Bevacizumab in the First-line Treatment of Advanced CRC(ROCB Study)

NCT03813641 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-09-09

No results posted yet for this study

Summary

Raltitrexed is an inhibitor of thymidylate synthase.As a folate antimetabolite drug, raltitrexed has been used in treatment of colorectal cancer(CRC) since 1998, and also used in malignant mesothelioma.Several phase III studies performed in patients with advanced CRC showed that it is as effective as 5-fluorouracil(5-FU) /leucovorin(LV) with regard to response rates and survival. The combination of raltitrexed with oxaliplatin shows response rates of 41%-54% and median survivals of 14.6-14.8 months, which are comparable to those achieved with 5-FU/LV combination with oxaliplatin. This study discussed the efficacy and safety of raltitrexed-oxaliplatin(RALOX) combined with bevacizumab or capecitabine-oxaliplatin(CAPOX) combined with bevacizumab in first-line treatment of patients with advanced colorectal cancer who could not undergo radical surgery. The main endpoint will be progression free survival (PFS). The secondary endpoints will be overall survival, objective response rate and disease control rate (OS,ORR and DCR).It is expected that raltitrexed may be one of options for the treatment of advanced CRC in the first-line setting.

Conditions

Interventions

DRUG

Raltitrexed

Experimental: Oxaliplatin + Raltitrexed + Bevacizumab The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Raltitrexed (3mg/m2, intravenous drip for 15 minutes, d1)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.

DRUG

Capecitabine

Other: Oxaliplatin + Capecitabine + Bevacizumab The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Capecitabine (1000mg/m2 po. d1-14)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.

Sponsors & Collaborators

  • Shenzhen People's Hospital

    lead OTHER

Principal Investigators

  • Ruilian Xu, MD · Shen Zhen People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2021-02-28
Completion
2021-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03813641 on ClinicalTrials.gov