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NCT Number: NCT01307878

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

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.

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Key information

Conditions

Colorectal Neoplasms Chemotherapy; Maternal, Affecting Fetus Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhongshan hospital, Fudan university

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chemotherapy ± targeted therapy

Drug

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

Other names: chemotherapy plus targeted therapy

Primary outcomes

  1. Progression-free survival

    Time frame: Up to 3 years

    Time from randomization to the date of disease progression or to death of any cause

Secondary outcomes

  1. Overall survival

    Time frame: Up to 3 years

    Time from randomization to death from any cause or the date of the last follow-up

  2. Tumor response

    Time frame: Up to 6 months

    Response according to RECIST 1.1

  3. Secondary resection rate Second radical resectability

    Time frame: Up to 6 months

    The rate of patients converted to resection for liver metastases

  4. Surgical complications

    Time frame: 30 days after surgery

    The proportion of patients with any complications occurred within 30 days after surgery

  5. Toxicity of chemotherapy

    Time frame: Up to 6 months

    Patients will be evaluated for Adverse Events at the start of each treatment cycle according to NCI CTC 3.0 criteria

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • Changhai Hospital
  • Ruijin Hospital
  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2011
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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