NCT02972541|UnknownDMC

Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer

NACSOC

NeoAdjuvant Chemotherapy Versus Surgery Alone After Stent Placement for Left-sided Obstructive Colonic Cancer:a Multicenter, Controlled, Open-label Clinical Trial (NACSOC Trial)

Beijing Chao Yang Hospital ClinicalTrials.gov

Compare

1 other identifier

2016-161-1

Study Type

interventional

Target

248

Locations

1 country

Sites

Timeline

RegisteredNov 2016

StartedSep 2016

CompletionDec 2023

Brief 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. 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

248

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline

Completed

Started Sep 2016

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach

1 country

32 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.3 years study duration

First Submitted

Initial submission to the registry

September 8, 2016

Completed

22 days until next milestone

Study Start

First participant enrolled

September 30, 2016

Completed

2 months until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed

7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed

Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

7.3 years

First QC Date

September 8, 2016

Last Update Submit

February 4, 2021

Conditions

Colorectal Cancer Neoadjuvant Chemotherapy Stent Obstruction

Outcome Measures

Primary Outcomes (3)

Disease free survival
From date of randomization until the date of tumor recurrence or death from any cause, assessed up to 5 years
Overall survival
From date of randomization until the date of death from any cause, assessed up to 5 years
Rate of stoma formation
From date of randomization until the follow-up ended, assessed up to 5 years

Secondary Outcomes (6)

Surgical complication
From date of randomization until the first follow-up ended, assessed up to 30 days
Rates of primary colorectal anastomosis
From date of randomization until the first follow-up ended, assessed up to 30 days
R0 resection rate
From date of randomization until the first follow-up ended, assessed up to 30 days
Re-operation rate
From date of randomization until the follow-up ended, assessed up to 5 years
Chemotherapy complete rate
From date of randomization until the chemotherapy ended, assessed up to 1 years
+1 more secondary outcomes

Study Arms (2)

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.

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.

Device: Stenting with immediate Surgery

Interventions

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 neoadjuvant chemotherapy

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.

Stenting with Immediate Surgery

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
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

You may not qualify if:

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.

Contact the study team to confirm eligibility.