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

Colorectal Neoplasms Clinical Trial

Official title:

Pre-operation Chemotherapy of Primary Tumor Resection for Colorectal Cancer Patients With Asymptomatic Resectable Primary Lesion and Synchronous Unresectable Liver-limited Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307878
• Other study ID #: RECUT
• Status: Completed
• Phase: Phase 3
• Start date: June 2012
• Est. completion date: June 2021

Study information

• Verified date: June 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy; Maternal, Affecting Fetus
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

Intervention

Drug:
• chemotherapy ± targeted therapy
Chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.

Locations

Country	Name	City	State
China	Zhongshan hospital, Fudan university	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Fudan University	Changhai Hospital, Ruijin Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Time from randomization to the date of disease progression or to death of any cause	Up to 3 years
Secondary	Overall survival	Time from randomization to death from any cause or the date of the last follow-up	Up to 3 years
Secondary	Tumor response	Response according to RECIST 1.1	Up to 6 months
Secondary	Secondary resection rate Second radical resectability	The rate of patients converted to resection for liver metastases	Up to 6 months
Secondary	Surgical complications	The proportion of patients with any complications occurred within 30 days after surgery	30 days after surgery
Secondary	Toxicity of chemotherapy	Patients will be evaluated for Adverse Events at the start of each treatment cycle according to NCI CTC 3.0 criteria	Up to 6 months