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A new notion"Fast Track Multi-Discipline Treatment" for colorectal cancer is thought with several benefits such as shorter hospitalization stay and less costs. This randomized study aims to compare the differences between conventional and Fast Track Multi-Discipline Treatment for colorectal cancer in hospitalization day, complications, costs and quality of life.
Laparoscopic Surgery, Fast Track Treatment and XELOX Chemotherapy have been introduced in the treatment of colorectal cancer. All of these procedures are contributed to reduce the hospitalization stay. However, the most economical mode for combination of these procedures is still unclear. This is a randomized controlled study, a new notion"Fast Track Multi-Discipline Treatment" is proposed, which is the combination of the Laparoscopic Surgery, Fast track perioperative treatment during perioperative period and XELOX Chemotherapy. The purpose of this study is to compare the Fast Track Multi-Discipline Treatment with the conventional treatment(Open Surgery with conventional treatment during perioperative period and mFolfox6 chemotherapy) for colorectal cancer on several aspects like the average hospitalization day, complications, costs and quality of life.The focus of the study will be to investigate whether the Fast Track Multi-Discipline Treatment reduces hospital stay with similar complications compared with conventional perioperative treatment. Moreover, the trial will clarify whether laparoscopic surgery is essential for Fast Track Multi-Discipline Treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Treatment （Laparoscopic） | Active Comparator | Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy. |
|
| FTMD Treatment （Laparoscopic） | Active Comparator | Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy. |
|
| Conventional Treatment（Open Surgery） | Active Comparator | Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy. |
|
| FTMD Treatment（Open Surgery） | Active Comparator | Randomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Surgery for Colorectal Cancer | Procedure | Laparoscopic surgery for colorectal cancer using STORZ laparoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| hospitalization day | The overall hospitalization stay during treatment from the first day in hospital to leave hospital when finish adjuvant chemotherapy or surgery (for patients who don't need chemotherapy). | 6-month post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| surgical complications | Surgical complications include injury of ureter, intraoperative transfusion, infection of incision and anastomotic leakage etc. | 3-month post surgery |
| chemotherapy related adverse event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ke-Feng Ding, PhD/MD | The Second Affiliated Hospital, and The Key Laboratory of Cancer Prevention and Intervention, China National Ministry of Education, Zhejiang University College of Medicine. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital Zhejiang University College of Medicine | Hangzhou | Zhejiang | 310999 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31647032 | Derived | Li J, Kong XX, Zhou JJ, Song YM, Huang XF, Li GH, Ying XJ, Dai XY, Lu M, Jiang K, Fu DL, Li XL, He JJ, Wang JW, Sun LF, Xu D, Xu JY, Chen M, Tian Y, Li JS, Yan M, Yuan Y, Ding KF. Fast-track multidisciplinary treatment versus conventional treatment for colorectal cancer: a multicenter, open-label randomized controlled study. BMC Cancer. 2019 Oct 23;19(1):988. doi: 10.1186/s12885-019-6188-x. | |
| 25649903 |
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|
| XELOX Chemotherapy | Drug | XELOX chemotherapy |
|
|
| mFolfox6 chemotherapy | Drug | Conventional (mFolfox6) chemotherapy |
|
|
| Fast Track Perioperative Treatment | Other | Fast track treatment during perioperation period |
|
|
| Conventional Perioperative Treatment | Other | Conventional treatment during perioperation period |
|
|
| Open Surgery for Colorectal Cancer | Procedure | Open surgery for colorectal cancer using conventional methods |
|
|
Chemotherapy related adverse event, according to NCI CTCAE Version 3.0, include nausea, vomit, diarrhea and neutropenia etc.
| 6-month post surgery |
| quality of life | Quality of life will be measured by EORTC QLQ-C30 and QLQ-CR38 questionaire. | preoperation, 3-month post surgery and 6-month post surgery |
| hospitalization costs | The overall hospitalization costs from the first day in hospital to day that adjuvant chemotherapy finished. | 6-month post surgery |
| People's Hospital of Shaoxing |
| Shaoxing |
| Zhejiang |
| 312000 |
| China |
| Derived |
| Xu D, Li J, Song Y, Zhou J, Sun F, Wang J, Duan Y, Hu Y, Liu Y, Wang X, Sun L, Wu L, Ding K. Laparoscopic surgery contributes more to nutritional and immunologic recovery than fast-track care in colorectal cancer. World J Surg Oncol. 2015 Feb 4;13:18. doi: 10.1186/s12957-015-0445-5. |
| 22111914 | Derived | Zhou JJ, Li J, Ying XJ, Song YM, Chen R, Chen G, Yan M, Ding KF. Fast track multi-discipline treatment (FTMDT trial) versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study. BMC Cancer. 2011 Nov 24;11:494. doi: 10.1186/1471-2407-11-494. |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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