Colon CancerPhase 3PEPCORLINCT02912052
Perioperative Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable Liver Metastasis
A Phase 3 study testing Peri-operative chemotherapy and postoperative chemotherapy in people with Colon Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Peri-operative chemotherapy and postoperative chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Colon Cancer
- Being tested
- Peri-operative chemotherapy, postoperative chemotherapy
- Keywords
- Perioperative Chemotherapy, Postoperative Chemotherapy, Colon Cancer, Resectable Liver Metastasis
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-operative chemotherapyDrug
Also called XELOX
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)
postoperative chemotherapyDrug
Also called XELOX
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)
| Study group | Role | What they receive |
|---|---|---|
| Peri-operative chemotherapy | Experimental | Patients receive 2 cycles of chemotherapy before surgery,and contniue to receive another 4 cycles of chemotherapy 21-28 days later after surgery. Receives: Drug: Peri-operative chemotherapy |
| postoperative chemotherapy | Active comparator | Patients receive 6 cycles of chemotherapy 21-28 days later after surgery. Receives: Drug: postoperative chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival，DFS
Measured: 5 years
Secondary outcomes (1)
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fumin Zhang, PHD, Study director, Professor Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912052
- Sponsor's protocol ID
- SYM20160908
- Acronym
- PEPCORLI
- Status last verified
- Sep 2016
- First submitted
- 21 Sep 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Wang ZM, Chen YY, Chen FF, Wang SY, Xiong B. Peri-operative chemotherapy for patients with resectable colorectal hepatic metastasis: A meta-analysis. Eur J Surg Oncol. 2015 Sep;41(9):1197-203. doi: 10.1016/j.ejso.2015.05.020. Epub 2015 Jun 11.
PubMed 26094113Bilchik AJ, Poston G, Adam R, Choti MA. Prognostic variables for resection of colorectal cancer hepatic metastases: an evolving paradigm. J Clin Oncol. 2008 Nov 20;26(33):5320-1. doi: 10.1200/JCO.2008.18.3152. Epub 2008 Oct 20. No abstract available.
PubMed 18936470Portier G, Elias D, Bouche O, Rougier P, Bosset JF, Saric J, Belghiti J, Piedbois P, Guimbaud R, Nordlinger B, Bugat R, Lazorthes F, Bedenne L. Multicenter randomized trial of adjuvant fluorouracil and folinic acid compared with surgery alone after resection of colorectal liver metastases: FFCD ACHBTH AURC 9002 trial. J Clin Oncol. 2006 Nov 1;24(31):4976-82. doi: 10.1200/JCO.2006.06.8353.
PubMed 17075115Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Mauer M, Tanis E, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1208-15. doi: 10.1016/S1470-2045(13)70447-9. Epub 2013 Oct 11.
PubMed 24120480Araujo R, Gonen M, Allen P, Blumgart L, DeMatteo R, Fong Y, Kemeny N, Jarnagin W, D'Angelica M. Comparison between perioperative and postoperative chemotherapy after potentially curative hepatic resection for metastatic colorectal cancer. Ann Surg Oncol. 2013 Dec;20(13):4312-21. doi: 10.1245/s10434-013-3162-8. Epub 2013 Jul 30.
PubMed 23897009Tamandl D, Gruenberger B, Herberger B, Kaczirek K, Gruenberger T. Surgery after neoadjuvant chemotherapy for colorectal liver metastases is safe and feasible in elderly patients. J Surg Oncol. 2009 Oct 1;100(5):364-71. doi: 10.1002/jso.21259.
PubMed 19235181Khoo E, O'Neill S, Brown E, Wigmore SJ, Harrison EM. Systematic review of systemic adjuvant, neoadjuvant and perioperative chemotherapy for resectable colorectal-liver metastases. HPB (Oxford). 2016 Jun;18(6):485-93. doi: 10.1016/j.hpb.2016.03.001. Epub 2016 Apr 20.
PubMed 27317952Schmoll HJ, Cartwright T, Tabernero J, Nowacki MP, Figer A, Maroun J, Price T, Lim R, Van Cutsem E, Park YS, McKendrick J, Topham C, Soler-Gonzalez G, de Braud F, Hill M, Sirzen F, Haller DG. Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients. J Clin Oncol. 2007 Jan 1;25(1):102-9. doi: 10.1200/JCO.2006.08.1075.
PubMed 17194911Fong Y, Salo J. Surgical therapy of hepatic colorectal metastasis. Semin Oncol. 1999 Oct;26(5):514-23.
PubMed 10528899Muratore A, Zorzi D, Bouzari H, Amisano M, Massucco P, Sperti E, Capussotti L. Asymptomatic colorectal cancer with un-resectable liver metastases: immediate colorectal resection or up-front systemic chemotherapy? Ann Surg Oncol. 2007 Feb;14(2):766-70. doi: 10.1245/s10434-006-9146-1. Epub 2006 Nov 14.
PubMed 17103261Fong Y, Cohen AM, Fortner JG, Enker WE, Turnbull AD, Coit DG, Marrero AM, Prasad M, Blumgart LH, Brennan MF. Liver resection for colorectal metastases. J Clin Oncol. 1997 Mar;15(3):938-46. doi: 10.1200/JCO.1997.15.3.938.
PubMed 9060531
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable Liver Metastasis: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02912052
- Acronym / sponsor ID
- PEPCORLI / SYM20160908
- Conditions
- Colon Cancer
- Keywords
- Perioperative Chemotherapy, Postoperative Chemotherapy, Colon Cancer, Resectable Liver Metastasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-operative chemotherapy | Experimental | Drug: Peri-operative chemotherapyPatients receive 2 cycles of chemotherapy before surgery,and contniue to receive another 4 cycles of chemotherapy 21-28 days later after surgery. |
| postoperative chemotherapy | Active comparator | Drug: postoperative chemotherapyPatients receive 6 cycles of chemotherapy 21-28 days later after surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peri-operative chemotherapyAlso: XELOXPatients 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) | Drug | Peri-operative chemotherapy |
| postoperative chemotherapyAlso: XELOXPatients 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) | Drug | postoperative chemotherapy |
Primary outcome
Disease free survival，DFS
Time frame: 5 years
1 secondary outcome
Overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Background: PubMed 26094113Wang ZM, Chen YY, Chen FF, Wang SY, Xiong B. Peri-operative chemotherapy for patients with resectable colorectal hepatic metastasis: A meta-analysis. Eur J Surg Oncol. 2015 Sep;41(9):1197-203. doi: 10.1016/j.ejso.2015.05.020. Epub 2015 Jun 11.
- Background: PubMed 18936470Bilchik AJ, Poston G, Adam R, Choti MA. Prognostic variables for resection of colorectal cancer hepatic metastases: an evolving paradigm. J Clin Oncol. 2008 Nov 20;26(33):5320-1. doi: 10.1200/JCO.2008.18.3152. Epub 2008 Oct 20. No abstract available.
- Background: PubMed 17075115Portier G, Elias D, Bouche O, Rougier P, Bosset JF, Saric J, Belghiti J, Piedbois P, Guimbaud R, Nordlinger B, Bugat R, Lazorthes F, Bedenne L. Multicenter randomized trial of adjuvant fluorouracil and folinic acid compared with surgery alone after resection of colorectal liver metastases: FFCD ACHBTH AURC 9002 trial. J Clin Oncol. 2006 Nov 1;24(31):4976-82. doi: 10.1200/JCO.2006.06.8353.
- Background: PubMed 24120480Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Mauer M, Tanis E, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1208-15. doi: 10.1016/S1470-2045(13)70447-9. Epub 2013 Oct 11.
- Background: PubMed 23897009Araujo R, Gonen M, Allen P, Blumgart L, DeMatteo R, Fong Y, Kemeny N, Jarnagin W, D'Angelica M. Comparison between perioperative and postoperative chemotherapy after potentially curative hepatic resection for metastatic colorectal cancer. Ann Surg Oncol. 2013 Dec;20(13):4312-21. doi: 10.1245/s10434-013-3162-8. Epub 2013 Jul 30.
- Background: PubMed 19235181Tamandl D, Gruenberger B, Herberger B, Kaczirek K, Gruenberger T. Surgery after neoadjuvant chemotherapy for colorectal liver metastases is safe and feasible in elderly patients. J Surg Oncol. 2009 Oct 1;100(5):364-71. doi: 10.1002/jso.21259.
- Background: PubMed 27317952Khoo E, O'Neill S, Brown E, Wigmore SJ, Harrison EM. Systematic review of systemic adjuvant, neoadjuvant and perioperative chemotherapy for resectable colorectal-liver metastases. HPB (Oxford). 2016 Jun;18(6):485-93. doi: 10.1016/j.hpb.2016.03.001. Epub 2016 Apr 20.
- Background: PubMed 17194911Schmoll HJ, Cartwright T, Tabernero J, Nowacki MP, Figer A, Maroun J, Price T, Lim R, Van Cutsem E, Park YS, McKendrick J, Topham C, Soler-Gonzalez G, de Braud F, Hill M, Sirzen F, Haller DG. Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients. J Clin Oncol. 2007 Jan 1;25(1):102-9. doi: 10.1200/JCO.2006.08.1075.
- Background: PubMed 10528899Fong Y, Salo J. Surgical therapy of hepatic colorectal metastasis. Semin Oncol. 1999 Oct;26(5):514-23.
- Background: PubMed 17103261Muratore A, Zorzi D, Bouzari H, Amisano M, Massucco P, Sperti E, Capussotti L. Asymptomatic colorectal cancer with un-resectable liver metastases: immediate colorectal resection or up-front systemic chemotherapy? Ann Surg Oncol. 2007 Feb;14(2):766-70. doi: 10.1245/s10434-006-9146-1. Epub 2006 Nov 14.
- Background: PubMed 9060531Fong Y, Cohen AM, Fortner JG, Enker WE, Turnbull AD, Coit DG, Marrero AM, Prasad M, Blumgart LH, Brennan MF. Liver resection for colorectal metastases. J Clin Oncol. 1997 Mar;15(3):938-46. doi: 10.1200/JCO.1997.15.3.938.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fumin Zhang, PHD study director
Professor Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peri-operative chemotherapy and postoperative chemotherapy in people with Colon Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueming Sun, PHD (02568136026, jssym@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival，DFS (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02912052, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.