Perioperative Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable Liver Metastasis (PEPCORLI)

September 22, 2016 updated by: The First Affiliated Hospital with Nanjing Medical University

Peri-operative Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable Liver Metastasis: a Prospective Randomized Clinical Trial

A prospective Randomized Clinical Trial to investigate the Effect ofPeri-operative Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable Liver Metastasis

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Colon cancer (colorectal cancer CRC) is one of the most common malignant tumor of digestive tract, has become the global incidence of third malignant tumors, including colorectal cancer proportion increased year by year. With the way of life of residents in our country, the adjustment of diet and aging progress, the incidence of colorectal cancer is rising the trend, and most patients have been found in advanced disease. Tumor metastasis is an important factor affecting the prognosis of colon cancer, liver metastasis, especially, including simultaneous liver metastases and delayed liver metastasis from colon cancer, about 20% to 34% will appear at the same time of liver metastasis, about 40-50% of CRC patients died of liver metastasis at present, multi disciplinary team treatment to surgical treatment of the absolute dominance of the more and more attention, and benefit, but the optimum sequence of chemotherapy and surgery, is still unclear. The preoperative chemotherapy Potential advantages include: early treatment of micrometastasis; assessment of tumor response to chemotherapy (with prognostic value, contribute to the development of postoperative treatment plan); for those patients with early progression can avoid local treatment. Preoperative treatment of the potential disadvantages include: missed the surgery opportunity window period ", probably because in early stage of tumor progress, may also be because chemotherapy achieved complete remission and to determine the extent of resection surgery has become extremely difficult.2015 second edition of the NNCN guidelines that resectable metastatic disease initial resectable patients may be liver resection, adjuvant chemotherapy and postoperative; another alternative treatment mode is around perioperative chemotherapy (perioperative chemotherapy and postoperative chemotherapy). Therefore, gaps in the determination of the timing of chemotherapy is still the guide, worth exploring.

I center to carry out laparoscopic resection of colon cancer has been more than ten years, the accumulated number of cases more than 1000 cases, with rich experience of colon cancer. Comprehensive treatment including surgery, oncology, Radiology, pathology, Department of radiotherapy, a number of departments, the Department of endoscopy MDT team, and won the outstanding team of Chinese Medical Doctor Association in 2016 MDT honor.

This study used a prospective randomized method, evaluation of colon cancer with simultaneous resectable liver metastatic lesions and peri chemotherapy surgery after neoadjuvant chemotherapy of two therapeutic schemes for short-term and long-term effect, is expected to summarize the prospective data to support the operation and chemotherapy

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

(1) 18-80 years old, patients with synchronous liver metastatic colorectal cancer confirmed by pathology diagnosis(2) ASA score: I-III (3) MDT evaluation: primary tumor can be cut, liver metastases can get complete resection at R0 level. The adjacent Hepatic segments have enough blood flow to be shared and retain sufficient liver function, liver residual volume is larger than or equal to 50%; general condition of the patient is good enough, without extrahepatic unresectable metastasis, and can tolerate systemic chemotherapy. (4) there are evaluating lesions according to the RESIST 1 edition: at least the single path of the lesions can be accurately measured, and the maximum diameter of the conventional techniques (traditional physical examination, CT, X, MRI) ≥20mm CT≥10mm or spiral (5) within 3 weeks before entering the group , the laboratory test index and evaluation of the disease show good bone marrow, liver and kidney function reserve: 1) bone marrow function : Hb ≥ 90 g/L, neutrophil absolute value is more than 1.5 x 109/L, the platelet count was larger than 80 x 109/L; 2) renal function: serum creatinine < 1.5 x ULN or the creatinine clearance rate≥ 50 mL/min; 3) liver function: AST and ALT ≤2.5 *ULN(if the disease is caused by tumor, AST and ALT≤5 *ULN, hemobilirubin ≤2 *ULN. (6) signed the informed consent.

Exclusion Criteria:

(1) the pathological diagnosis is not adenocarcinoma or multiform pathological types. (2)with clinical symptoms requiring emergency surgery for treatment (complete obstruction, bleeding, intestinal perforation). (3) have received chemotherapy treatment or combined with other the anti-tumor treatment. (4) with serious basic diseases: heart disease, kidney failure, severe liver dysfunction or liver failure, coagulation dysfunction or oral dose of anticoagulant drugs, a baseline proteinuria (total urine protein >1g/d). (5) any other contraindications for the use of chemotherapy treatment (6) patients with pregnancy (7)with previous or existing central nervous system metastasis. (8) there have been cerebrovascular accident or stroke in the past 12 months (9) any other drugs may affect safety or surgical operation history (10) multiple primary colon cancer patients, or suffer from other malignant tumors, or have been systematic chemotherapy (11) with neurological or psychiatric disorders affecting cognitive ability (12)patients cannot accept the treatment because of the psychological, family or social reasons(13) patients with liver metastasis get complete remission after preoperative chemotherapy(14)patients with severe postoperative complications cannot do chemotherapy within the prescribed time (15)liver metastases cannot get hameochronous and R0 standard resection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peri-operative chemotherapy
Patients receive 2 cycles of chemotherapy before surgery,and contniue to receive another 4 cycles of chemotherapy 21-28 days later after surgery.
Drug: Peri-operative chemotherapy
Patients receive 2 cycles of chemotherapy before surgery,and contniue to receive another 4 cycles of chemotherapy 21-28 days later after surgery.The chemotherapy regime is XELOX(oxaliplatin130mg/m2 ivd d1 + Capecitabine1000mg/m2 po bid d1-14, 21d/cycle)
Other Names:
  • XELOX
Active Comparator: postoperative chemotherapy
Patients receive 6 cycles of chemotherapy 21-28 days later after surgery.
Drug: postoperative chemotherapy
Patients receive 6 cycles of chemotherapy 21-28 days later after surgery.The chemotherapy regime is XELOX(oxaliplatin130mg/m2 ivd d1 + Capecitabine1000mg/m2 po bid d1-14, 21d/cycle)
Other Names:
  • XELOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease free survival，DFS
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years

Other Outcome Measures

Outcome Measure
Time Frame
operative time
Time Frame: 1 day
1 day
local recurrence rate
Time Frame: 5 years
5 years
number of lymph nodes retrieved
Time Frame: 1 day
1 day
recurrence-free survival
Time Frame: 5 years
5 years
length of postoperative hospital stay
Time Frame: 30 days
30 days
early complication rate
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Director: Fumin Zhang, PHD, Professor Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYM20160908

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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