Colorectal CancerNACSOCNCT02972541
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
A study testing Stenting with neoadjuvant chemotherapy and Stenting with immediate Surgery in people with Colorectal Cancer and Neoadjuvant Chemotherapy, run by Beijing Chao Yang Hospital at 32 sites in China.
Trial summary
Colorectal cancer is the fourth most common cancer in China. Up to 30% of patients with colorectal cancer present with an emergency obstruction of the large bowel at the time of diagnosis, and 70% of all malignant obstruction occurs in the left-sided colon. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Neoadjuvant Chemotherapy, Stent
- What is being tested?
- Stenting with neoadjuvant chemotherapy and Stenting with immediate Surgery
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 32 sitesChina
- Study dates
- 30 Sep 2016to 30 Dec 2023
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiologically proven colonic obstruction of the left colon/upper rectum presumed secondary to a carcinoma
- Able to give written, informed consent
- Primary tumor was resectable
- ECOG score 0 or 1
- Haemoglobin greater than 100 g/L after transfusion before chemotherapy,
- White blood cells greater than 3.0×10⁹ /L
Show all 10Show fewer
- Platelets greater than 100×10⁹ / L;
- Glomerular filtration rate greater than 50 mL per minute as calculated by the Wright or Cockroft formula
- Bilirubin less than 1.5×Upper Limit of Normal(ULN)
- ALT and AST less than 2.5×ULN
Who cannot join
- Distal rectal cancers(equal or less than 10cm from the anal verge)
- Patients with signs of peritonitis and/or bowel perforation
- Patients who did not give informed consent
- Patients who were considered unfit for operative treatment or refuse surgery.
- Patients with suspected or proven metastatic adenocarcinoma;
- Patients with unresectable colorectal cancer, or planning for palliative treatment.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
China32 sites, 32 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Zhen Jun Wang, M.D., 86-013601393711, drzhenjun@163.com
Zhen Jun Wang
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100020
zhongtao zhang, MD, 8610-63016616, yaohongwei@medmail.com.cn
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100020
gang xiao, MD, 8610-85132266, xgbj@sina.com
- Recruiting
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100020
xiaohui du, MD, duxiaohui301@sina.com
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100020
fei li, MD, feili36@ccmu.edu.cn
- Recruiting
Department of Colorectal Surgery, Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
xi-shan wang, MD, 8610-87787110, 794157254@qq.com
- Recruiting
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033
tongjun liu, MD, tongjunliu@163.com
- Recruiting
the Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
xiaorong li, MD, lixiaorong@medmail.com
- Recruiting
Hunan Provincial People'S Hospital
Changsha, Hunan, 410005
zhongcheng huang, MD, 86731-83929555, huangzc369@163.com
- Recruiting
West China Hospital Sichuan University
Chengdu, Sichuan, 610041
zi-qiang wang, MD, wangzqzyh@163.com
- Recruiting
the First Affiliated Hospital of Dalian Medical University
Dalian, Shandong, 116011
wei bi, MD
- Recruiting
the Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510655
lei wang, MD, 8620-38254011, wangl9@mail.sysu.edu.cn
- Recruiting
the First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
jianjiang lin, MD, ljjzju@163.com
- Recruiting
First Affiliated Hospital of Jiamusi University
Jiamusi, Heilongjiang, 154003
fujun chen, MD, gck8801079@163.com
- Recruiting
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014
lijian xia, MD, xiaalbert2758@163.com
- Recruiting
Shandong General Hospital
Jinan, Shandong, 250021
changqing jing, MD, jing66510122@sina.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250022
Yong Dai, M.D., 18560085128@163.com
- Recruiting
Jinhua Hospital of Zhejiang University
Jinhua, Zhejiang, 321000
jinlin du, MD, djl9090@163.com
- Recruiting
the 150th Central Hospital of Chinese PLA
Luoyang, Henan, 471031
dong wei
- Recruiting
the First Affiliated Hospital of Guangxi Medical University
Nanjing, Guangxi, 530021
wei-zhong tang, MD, 13978157758@163.com
- Recruiting
the Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
yun lu, MD, cloudylucn@126.com
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200000
chuangang fu, MD, fugang416@126.com
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
yong feng, MD, fengy@sj-hospital.org
- Recruiting
Fourth Hospital of Hebei Medicial University
Shijiazhuang, Hebei, 050011
guiying wang, MD, 86311-86095588, tizq12@vip.163.com
- Recruiting
Shanxi Tumor Hospital
Taiyuan, Shanxi, 030013
xiaobo liang, MD, 860351-4651714, liangxiaobo@medmail.com.cn
- Recruiting
the Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
changbao liu, MD, lcb@wzhealth.com
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430000
keliang zhang, MD, 8627-87670242, 13071238088@163.com
- Recruiting
Hubei General Hospital
Wuhan, Hubei, 430060
shilun tong, MD, tongshilun@163.com
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
qun qian, MD, 86-013098824999, qunqian2007@163.com
- Recruiting
the First Affiliated Hospital of Xi'An Jiaotong University
Xi’an, Shanxi, 710061
xiangming che, MD, chexiang@mail.xjtu.edu.cn
- Recruiting
the First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
weitang yuan, MD, 13978157758@163.com
- Recruiting
the Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014
zhigang pang, MD, pzg63726@sina.com
About this study
Official title: NeoAdjuvant Chemotherapy Versus Surgery Alone After Stent Placement for Left-sided Obstructive Colonic Cancer:a Multicenter, Controlled, Open-label Clinical Trial (NACSOC Trial)
Colorectal cancer is the fourth most common cancer in China. Up to 30% of patients with colorectal cancer present with an emergency obstruction of the large bowel at the time of diagnosis, and 70% of all malignant obstruction occurs in the left-sided colon. Patients with obstruction are associated with worse oncologic outcomes compared with those having nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and about two-thirds of such patients end up with a permanent stoma.
Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve obstruction prior to elective surgery) in patients with potentially resectable colorectal cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior to emergency surgery considering the short-term outcomes. SEMS is associated with lower morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma creation rate. Although about half of patients can achieve primary anastomosis after stent placement, the primary anastomosis rate is still significantly lower compared with nonobstructing elective surgery. The interval between stent placement and surgery may be not long enough that bowel decompression is insufficient at the time of operation. Furthermore，the long-term oncologic results regarding SEMS as a bridge to surgery are still limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One interpretation is that tumor cells may disseminate during the procedure of colonic stenting placement. We hypothesis that immediate chemotherapy after stenting may improve overall survival by eradicating micrometastasis. Moreover, neoadjuvant chemotherapy prolongs the interval between stent placement and surgery, and the time for bowel decompression is more sufficient, which may increase the success rate of primary anastomosis and decrease risk of stoma formation.
- Conditions
- Colorectal Cancer, Neoadjuvant Chemotherapy, Stent, Obstruction
- Being tested
- Stenting with neoadjuvant chemotherapy, Stenting with immediate Surgery
- Medical subject headings
- Colorectal Neoplasms, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stenting with neoadjuvant chemotherapyDevice
After clinical success of colonic stenting, patients will be given neoadjuvant chemotherapy. Surgery is performed after 3 cycles of mFOLFOX6 or 2 cycles of CapeOx. The choice of surgery performed is up to the individual consultant colorectal surgeon. Patients will receive 5-9 cycles of mFOLFOX6 or 4-6 cycles of CapeoX after surgery. Each cycle of mFOLFOX6 consists of racemic leucovorin 400 mg/m², oxaliplatin 85 mg/m² in a 2-h infusion, bolus fluorouracil 400 mg/m² on day 1, and a 46-h infusion of fluorouracil 2400 mg/m². Each cycle of CapeOx consists of oxaliplatin 130 mg/m2, capecitabine 100 mg/m2 twice daily for 14 days.
Stenting with immediate SurgeryDevice
After clinical success of colonic stenting, patients will undergo surgery 7-14 days later. The choice of surgery performed is up to the individual consultant colorectal surgeon. Patients will receive 8-12 cycles of mFOLFOX6 or 6-8 cycles of CapeoX after surgery. Each cycle of mFOLFOX6 consists of racemic leucovorin 400 mg/m², oxaliplatin 85 mg/m² in a 2-h infusion, bolus fluorouracil 400 mg/m² on day 1, and a 46-h infusion of fluorouracil 2400 mg/m². Each cycle of CapeOx consists of oxaliplatin 130 mg/m2, capecitabine 100 mg/m2 twice daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Stenting with neoadjuvant chemotherapy | Experimental | After clinical success of colonic stenting, patients will receive neoadjuvant chemotherapy with mFOLFOX6 regimen for 3 cycles or CapeOx regimen for 2 cycles. Patients will undergo surgery 3-5 weeks after the last cycle of chemotherapy, type and extent of the surgery will be selected by the surgeon. Receives: Device: Stenting with neoadjuvant chemotherapy |
| Stenting with Immediate Surgery | Active comparator | After clinical success of colonic stenting, patients will undergo surgery 7-14 days after inclusion. Type and extent of the elective surgery will be selected by the surgeon. Receives: Device: Stenting with immediate Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: From date of randomization until the date of tumor recurrence or death from any cause, assessed up to 5 years
Overall survival
Measured: From date of randomization until the date of death from any cause, assessed up to 5 years
Rate of stoma formation
Measured: From date of randomization until the follow-up ended, assessed up to 5 years
Secondary outcomes (6)
Surgical complication
Including but not limited to: anastomotic leakage, wound infection, intra-abdominal sepsis,perioperative mortality, etc.
Measured: From date of randomization until the first follow-up ended, assessed up to 30 days
Rates of primary colorectal anastomosis
The primary colorectal anastomosis was defined as: the patients received one-stage surgery and colorectal anastomosis.
Measured: From date of randomization until the first follow-up ended, assessed up to 30 days
R0 resection rate
R0 resection is defined as negative resection margins and no residual tumor.
Measured: From date of randomization until the first follow-up ended, assessed up to 30 days
Re-operation rate
Measured: From date of randomization until the follow-up ended, assessed up to 5 years
Chemotherapy complete rate
Measured: From date of randomization until the chemotherapy ended, assessed up to 1 years
Chemotherapy related complication
Measured: From date of randomization until the chemotherapy ended, assessed up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start30 Sep 2016
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Jun Wang, Beijing Chao Yang Hospital
- Investigators
- zhenjun wang, MD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972541
- Sponsor's protocol ID
- 2016-161-1
- Acronym
- NACSOC
- Status last verified
- Feb 2021
- First submitted
- 8 Sep 2016
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sabbagh C, Browet F, Diouf M, Cosse C, Brehant O, Bartoli E, Mauvais F, Chauffert B, Dupas JL, Nguyen-Khac E, Regimbeau JM. Is stenting as "a bridge to surgery" an oncologically safe strategy for the management of acute, left-sided, malignant, colonic obstruction? A comparative study with a propensity score analysis. Ann Surg. 2013 Jul;258(1):107-15. doi: 10.1097/SLA.0b013e31827e30ce.
PubMed 23324856van Hooft JE, Bemelman WA, Oldenburg B, Marinelli AW, Lutke Holzik MF, Grubben MJ, Sprangers MA, Dijkgraaf MG, Fockens P; collaborative Dutch Stent-In study group. Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Lancet Oncol. 2011 Apr;12(4):344-52. doi: 10.1016/S1470-2045(11)70035-3.
PubMed 21398178Young CJ, De-Loyde KJ, Young JM, Solomon MJ, Chew EH, Byrne CM, Salkeld G, Faragher IG. Improving Quality of Life for People with Incurable Large-Bowel Obstruction: Randomized Control Trial of Colonic Stent Insertion. Dis Colon Rectum. 2015 Sep;58(9):838-49. doi: 10.1097/DCR.0000000000000431.
PubMed 26252845Huang X, Lv B, Zhang S, Meng L. Preoperative colonic stents versus emergency surgery for acute left-sided malignant colonic obstruction: a meta-analysis. J Gastrointest Surg. 2014 Mar;18(3):584-91. doi: 10.1007/s11605-013-2344-9. Epub 2013 Oct 30.
PubMed 24170606Ohman U. Prognosis in patients with obstructing colorectal carcinoma. Am J Surg. 1982 Jun;143(6):742-7. doi: 10.1016/0002-9610(82)90050-2.
PubMed 7046484Kim JS, Hur H, Min BS, Sohn SK, Cho CH, Kim NK. Oncologic outcomes of self-expanding metallic stent insertion as a bridge to surgery in the management of left-sided colon cancer obstruction: comparison with nonobstructing elective surgery. World J Surg. 2009 Jun;33(6):1281-6. doi: 10.1007/s00268-009-0007-5.
PubMed 19363580Han J, Wang Z, Dai Y, Li X, Qian Q, Wang G, Wei G, Zeng W, Ma L, Zhao B, Wang Y, Yang K, Ding Z, Hu X. [Preliminary report on prospective, multicenter, open research of selective surgery after expandable stent combined with neoadjuvant chemotherapy in the treatment of obstructive left hemicolon cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Nov 25;21(11):1233-1239. Chinese.
PubMed 30506533
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeoAdjuvant Chemotherapy Versus Surgery Alone After Stent Placement for Left-sided Obstructive Colonic Cancer:a Multicenter, Controlled, Open-label Clinical Trial (NACSOC Trial)
- ClinicalTrials.gov ID
- NCT02972541
- Acronym / sponsor ID
- NACSOC / 2016-161-1
- Conditions
- Colorectal Cancer, Neoadjuvant Chemotherapy, Stent, Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 30 Sep 2016
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 23 Nov 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.
Colorectal cancer is the fourth most common cancer in China. Up to 30% of patients with colorectal cancer present with an emergency obstruction of the large bowel at the time of diagnosis, and 70% of all malignant obstruction occurs in the left-sided colon. Patients with obstruction are associated with worse oncologic outcomes compared with those having nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and about two-thirds of such patients end up with a permanent stoma.
Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve obstruction prior to elective surgery) in patients with potentially resectable colorectal cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior to emergency surgery considering the short-term outcomes. SEMS is associated with lower morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma creation rate. Although about half of patients can achieve primary anastomosis after stent placement, the primary anastomosis rate is still significantly lower compared with nonobstructing elective surgery. The interval between stent placement and surgery may be not long enough that bowel decompression is insufficient at the time of operation. Furthermore，the long-term oncologic results regarding SEMS as a bridge to surgery are still limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One interpretation is that tumor cells may disseminate during the procedure of colonic stenting placement. We hypothesis that immediate chemotherapy after stenting may improve overall survival by eradicating micrometastasis. Moreover, neoadjuvant chemotherapy prolongs the interval between stent placement and surgery, and the time for bowel decompression is more sufficient, which may increase the success rate of primary anastomosis and decrease risk of stoma formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stenting with neoadjuvant chemotherapy | Experimental | Device: Stenting with neoadjuvant chemotherapyAfter clinical success of colonic stenting, patients will receive neoadjuvant chemotherapy with mFOLFOX6 regimen for 3 cycles or CapeOx regimen for 2 cycles. Patients will undergo surgery 3-5 weeks after the last cycle of chemotherapy, type and extent of the surgery will be selected by the surgeon. |
| Stenting with Immediate Surgery | Active comparator | Device: Stenting with immediate SurgeryAfter clinical success of colonic stenting, patients will undergo surgery 7-14 days after inclusion. Type and extent of the elective surgery will be selected by the surgeon. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Radiologically proven colonic obstruction of the left colon/upper rectum presumed secondary to a carcinoma
- Able to give written, informed consent
- Primary tumor was resectable
- ECOG score 0 or 1
- Haemoglobin greater than 100 g/L after transfusion before chemotherapy,
Key exclusion criteria (6 listed)
- Distal rectal cancers(equal or less than 10cm from the anal verge)
- Patients with signs of peritonitis and/or bowel perforation
- Patients who did not give informed consent
- Patients who were considered unfit for operative treatment or refuse surgery.
- Patients with suspected or proven metastatic adenocarcinoma;
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 |
|---|---|---|
| Stenting with neoadjuvant chemotherapyAfter clinical success of colonic stenting, patients will be given neoadjuvant chemotherapy. Surgery is performed after 3 cycles of mFOLFOX6 or 2 cycles of CapeOx. The choice of surgery performed is up to the individual consultant colorectal surgeon. Patients will receive 5-9 cycles of mFOLFOX6 or 4-6 cycles of CapeoX after surgery. Each cycle of mFOLFOX6 consists of racemic leucovorin 400 mg/m², oxaliplatin 85 mg/m² in a 2-h infusion, bolus fluorouracil 400 mg/m² on day 1, and a 46-h infusion of fluorouracil 2400 mg/m². Each cycle of CapeOx consists of oxaliplatin 130 mg/m2, capecitabine 100 mg/m2 twice daily for 14 days. | Device | Stenting with neoadjuvant chemotherapy |
| Stenting with immediate SurgeryAfter clinical success of colonic stenting, patients will undergo surgery 7-14 days later. The choice of surgery performed is up to the individual consultant colorectal surgeon. Patients will receive 8-12 cycles of mFOLFOX6 or 6-8 cycles of CapeoX after surgery. Each cycle of mFOLFOX6 consists of racemic leucovorin 400 mg/m², oxaliplatin 85 mg/m² in a 2-h infusion, bolus fluorouracil 400 mg/m² on day 1, and a 46-h infusion of fluorouracil 2400 mg/m². Each cycle of CapeOx consists of oxaliplatin 130 mg/m2, capecitabine 100 mg/m2 twice daily for 14 days. | Device | Stenting with Immediate Surgery |
Primary outcome
Disease free survival
Time frame: From date of randomization until the date of tumor recurrence or death from any cause, assessed up to 5 years
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 5 years
Rate of stoma formation
Time frame: From date of randomization until the follow-up ended, assessed up to 5 years
6 secondary outcomes
Surgical complication
Time frame: From date of randomization until the first follow-up ended, assessed up to 30 days
Rates of primary colorectal anastomosis
Time frame: From date of randomization until the first follow-up ended, assessed up to 30 days
R0 resection rate
Time frame: From date of randomization until the first follow-up ended, assessed up to 30 days
Re-operation rate
Time frame: From date of randomization until the follow-up ended, assessed up to 5 years
Chemotherapy complete rate
Time frame: From date of randomization until the chemotherapy ended, assessed up to 1 years
Chemotherapy related complication
Time frame: From date of randomization until the chemotherapy ended, assessed up to 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Background: PubMed 23324856Sabbagh C, Browet F, Diouf M, Cosse C, Brehant O, Bartoli E, Mauvais F, Chauffert B, Dupas JL, Nguyen-Khac E, Regimbeau JM. Is stenting as "a bridge to surgery" an oncologically safe strategy for the management of acute, left-sided, malignant, colonic obstruction? A comparative study with a propensity score analysis. Ann Surg. 2013 Jul;258(1):107-15. doi: 10.1097/SLA.0b013e31827e30ce.
- Background: PubMed 21398178van Hooft JE, Bemelman WA, Oldenburg B, Marinelli AW, Lutke Holzik MF, Grubben MJ, Sprangers MA, Dijkgraaf MG, Fockens P; collaborative Dutch Stent-In study group. Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Lancet Oncol. 2011 Apr;12(4):344-52. doi: 10.1016/S1470-2045(11)70035-3.
- Background: PubMed 26252845Young CJ, De-Loyde KJ, Young JM, Solomon MJ, Chew EH, Byrne CM, Salkeld G, Faragher IG. Improving Quality of Life for People with Incurable Large-Bowel Obstruction: Randomized Control Trial of Colonic Stent Insertion. Dis Colon Rectum. 2015 Sep;58(9):838-49. doi: 10.1097/DCR.0000000000000431.
- Background: PubMed 24170606Huang X, Lv B, Zhang S, Meng L. Preoperative colonic stents versus emergency surgery for acute left-sided malignant colonic obstruction: a meta-analysis. J Gastrointest Surg. 2014 Mar;18(3):584-91. doi: 10.1007/s11605-013-2344-9. Epub 2013 Oct 30.
- Background: PubMed 7046484Ohman U. Prognosis in patients with obstructing colorectal carcinoma. Am J Surg. 1982 Jun;143(6):742-7. doi: 10.1016/0002-9610(82)90050-2.
- Background: PubMed 19363580Kim JS, Hur H, Min BS, Sohn SK, Cho CH, Kim NK. Oncologic outcomes of self-expanding metallic stent insertion as a bridge to surgery in the management of left-sided colon cancer obstruction: comparison with nonobstructing elective surgery. World J Surg. 2009 Jun;33(6):1281-6. doi: 10.1007/s00268-009-0007-5.
- Derived from this study: PubMed 30506533Han J, Wang Z, Dai Y, Li X, Qian Q, Wang G, Wei G, Zeng W, Ma L, Zhao B, Wang Y, Yang K, Ding Z, Hu X. [Preliminary report on prospective, multicenter, open research of selective surgery after expandable stent combined with neoadjuvant chemotherapy in the treatment of obstructive left hemicolon cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Nov 25;21(11):1233-1239. Chinese.
- Individual participant dataSharing planned: No
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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.
zhenjun wang, MD principal investigator
Beijing Chao Yang Hospital
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stenting with neoadjuvant chemotherapy and Stenting with immediate Surgery in people with Colorectal Cancer and Neoadjuvant Chemotherapy, run by Beijing Chao Yang Hospital at 32 sites 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 10 inclusion and 6 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 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites 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.
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 zhenjun wang, MD (8610-85231604, drzhenjun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: From date of randomization until the date of tumor recurrence or death from any cause, assessed up to 5 years). The study lists 3 primary outcomes in all. 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 NCT02972541, which also lists 7 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 8 Feb 2021.