New Adjuvant Chemotherapy of Asymptomatic Resectable Primary Lesion With Unresectable Liver-limited Metastases

Fudan University

Status and phase: Completed; Phase 3

Conditions: Chemotherapy; Maternal, Affecting Fetus; Liver Neoplasms; Neoplasm Metastasis; Colorectal Neoplasms

Treatments: Drug: chemotherapy ± targeted therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01307878

RECUT

Details and patient eligibility

About

To evaluate the survival benefit of pre-operation chemotherapy of primary tumor tesection (PTR) compared upfront PTR for colorectal cancer (CRC) patients with an asymptomatic resectable primary tumor and synchronous unresectable liver-limited metastases with conversion therapy intent.

Full description

Fast recovery with fewer postoperative complications, prevention of potential tumor-related complications during chemotherapy, life quality improvement, and also can alleviate the tumor load of patients, are some advantages of PTR that may play a role in improving cancer-specific survival. However, it should be pointed out that nearly all the retrospective and prospective studies for the beneficial of PTR enrolled more multi-organ metastases mCRC patients, and with palliative treatment purpose. As for unresectable colorectal liver-limited metastases (CRLMs) with good Eastern Cooperative Oncology Group performance status (ECOG PS), the primary objective is to make metastases resectable by high-intensity conversion therapy and achieved a state of no-evidence of disease. PTR were preferred performed before enrollment in some related RCT studies, including the CELIM study, CAIRO and CAIRO2 studies. Pooled-analysis of our two RCT studies, PTR pre or post chemotherapy for these unresectable liver-limited metastases patients had less morbidities and no mortalities, but no RCTs have focused on survival benefit of pre-operation chemotherapy of PTR for unresectable CRLMs.

Enrollment: 320 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 18 - 75 years old
• colorectal adenocarcinoma pathologically
• without any chemotherapy or radiotherapy
• unresectable liver metastasis and without other metastasis
• resectable colorectal cancer
• suitable for chemotherapy
• agreed by patients

Exclusion criteria

• age below 18 years old or greater than 75 years old
• haven't pathological diagnosis of colorectal adenocarcinoma
• with any chemotherapy or radiotherapy
• resectable liver metastasis or without other metastasis
• unresectable colorectal cancer
• unsuitable for chemotherapy
• not agreed by patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

arm A

Experimental group

Description:

Pre-PTR, chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.

Treatment:

Drug: chemotherapy ± targeted therapy

arm B

No Intervention group

Description:

Upfront PTR, then chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.