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

Primary Purpose

Colon Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Peri-operative chemotherapy
postoperative chemotherapy
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Perioperative Chemotherapy, Postoperative Chemotherapy, Colon Cancer, Resectable Liver Metastasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jiangsu province hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peri-operative chemotherapy

postoperative chemotherapy

Arm Description

Patients receive 2 cycles of chemotherapy before surgery,and contniue to receive another 4 cycles of chemotherapy 21-28 days later after surgery.

Patients receive 6 cycles of chemotherapy 21-28 days later after surgery.

Outcomes

Primary Outcome Measures

Disease free survival,DFS

Secondary Outcome Measures

Overall survival

Full Information

First Posted
September 21, 2016
Last Updated
September 22, 2016
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02912052
Brief Title
Perioperative Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable Liver Metastasis
Acronym
PEPCORLI
Official Title
Peri-operative Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable Liver Metastasis: a Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Perioperative Chemotherapy, Postoperative Chemotherapy, Colon Cancer, Resectable Liver Metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peri-operative chemotherapy
Arm Type
Experimental
Arm Description
Patients receive 2 cycles of chemotherapy before surgery,and contniue to receive another 4 cycles of chemotherapy 21-28 days later after surgery.
Arm Title
postoperative chemotherapy
Arm Type
Active Comparator
Arm Description
Patients receive 6 cycles of chemotherapy 21-28 days later after surgery.
Intervention Type
Drug
Intervention Name(s)
Peri-operative chemotherapy
Other Intervention Name(s)
XELOX
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
postoperative chemotherapy
Other Intervention Name(s)
XELOX
Intervention Description
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)
Primary Outcome Measure Information:
Title
Disease free survival,DFS
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
recurrence-free survival
Time Frame
5 years
Title
local recurrence rate
Time Frame
5 years
Title
length of postoperative hospital stay
Time Frame
30 days
Title
early complication rate
Time Frame
30 days
Title
operative time
Time Frame
1 day
Title
number of lymph nodes retrieved
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yueming Sun, PHD
Phone
02568136026
Email
jssym@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fumin Zhang, PHD
Organizational Affiliation
Professor Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Jiangsu province hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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26094113
Citation
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Perioperative Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable Liver Metastasis

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