Compare Efficacy and Safety of Raltitrexed-based and 5fu-based Neoadjuvant Chemotherapy for Colorectal Liver Metastasis

Zhejiang University

Status and phase: Terminated; Phase 3

Conditions: Liver Metastasis; Colorectal Cancer

Treatments: Drug: Raltitrexed-based chemotherapy; Drug: 5-fluorouracil-based chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02453490

CRCLM-01

Details and patient eligibility

About

This study is a multicenter ,randomization, open control study to evaluate the efficacy and safety of Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in the peri-operative treatment of patients with Liver Metastasis From colorectal cancer (CRC).

Full description

The contrast analysis is separately done on Raltitrexed plus oxaliplatin and 5-fluorouracil plus oxaliplatin;Raltitrexed plus irinotecan and 5-fluorouracil plus irinotecan.To investigate the objective response rate,the R0 resection rate, the early tumor shrinkage （ETS）and depth of response(DPR) and the safety profile.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed chinese colorectal cancer patients and imaging detection confirmed liver metastasis
2. previously no treatment for liver metastasis or Primary tumor had been removed and last additional chemotherapy over one year
3. Age of≥18 and ≤75
4. Adequate organ functions, as determined by normal bone marrow function (absolute neutrophil count2 x 109/L, platelets 100 x 109/L, White blood cells 4 x 109/L), liver function (serum bilirubin ≤ 2.5 x ULN, serum transaminases ≤2. 5x ULN)
5. ECOG≤1
6. Life Expectancy>6months
7. Signed written informed consent
8. Expected adequacy of follow-up

Exclusion criteria

1. Lesion is too small to assess by imaging
2. Extrahepatic metastases
3. Any anticancer chemotherapy in development within 4 weeks prior to study entry
4. Concurrent uncontrolled illness such as infection
5. Be allergic to medicines in the study
6. Pregnant or nursing patients
7. Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
8. Not willing or incapable to comply with all study visits and assessments
9. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

360 participants in 2 patient groups

Raltitrexed-based chemotherapy

Experimental group

Description:

Raltitrexed plus Oxaliplatin/Raltitrexed plus Irinotecan

Treatment:

Drug: Raltitrexed-based chemotherapy

Drug: Raltitrexed-based chemotherapy

5-fluorouracil-based chemotherapy

Active Comparator group

Description:

5-fluorouracil plus Oxaliplatin/5-fluorouracil plus Irinotecan

Treatment:

Drug: 5-fluorouracil-based chemotherapy

Drug: 5-fluorouracil-based chemotherapy