NCT02882269

Brief Summary

A randomized controlled clinical trial to compare the short and long outcomes of Neoadjuvant chemotherapy with postoperative chemotherapy in patients with resectable locally advanced colon cancer

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2016

Longer than P75 for phase_2

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

First Submitted

Initial submission to the registry

August 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

5 years

First QC Date

August 24, 2016

Last Update Submit

August 28, 2016

Conditions

Colon Cancer

Keywords

locally advanced colon cancerneoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • disease-free survival

    3 years

Secondary Outcomes (7)

  • overall survival

    3 years

  • recurrence-free survival

    3 years

  • local recurrence rate

    3 years

  • length of postoperative hospital stay

    30 days

  • early complication rate

    30 days

  • +2 more secondary outcomes

Study Arms (2)

Postoperative chemotherapy

ACTIVE COMPARATOR

Patients receive 6 months of chemotherapy after surgery.

Drug: Postoperative chemotherapy

Neoadjuvant chemotherapy

EXPERIMENTAL

Patients receive 3-4 cycles of chemotherapy before surgery. Preoperative and postoperative chemotherapy will be given for a total of 6 months.

Drug: Neoadjuvant chemotherapy

Interventions

Postoperative chemotherapyDRUG

Locally advanced colon cancer patients will receive surgery first, followed by 6 months of chemotherapy. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy.

Also known as: drug combination (FOLFOX, CapeOX or FOLFIRI) or Capecitabine monotherapy
Postoperative chemotherapy
Neoadjuvant chemotherapyDRUG

Neoadjuvant chemotherapy will be given to locally advanced colon cancer patients for 3-4 cycles. Surgery will be performed between 3 to 4 weeks subsequent to the last cycle of chemotherapy. After surgery, additional chemotherapy will be given. Preoperative and postoperative chemotherapy will be given for a total of 6 months. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy.

Also known as: drug combination (FOLFOX, CapeOX or FOLFIRI) or Capecitabine monotherapy
Neoadjuvant chemotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suitable for curative surgery between 18 to 80 years old;
  • American Society of Anesthesiologists(ASA) grade I-III;
  • Pathological diagnosis of adenocarcinoma;
  • Tumor located between the cecum and sigmoid colon;
  • Enhanced CT scan of chest, abdominal and pelvic cavity: preoperative assessment of tumor stage is T3-T4 N0 or T any N+ (according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015);there is no distant metastasis;
  • Informed consent;
  • No preoperative chemoradiotherapy;
  • No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

You may not qualify if:

  • Pregnant patient;
  • History of psychiatric disease;
  • Use of systemic steroids;
  • Simultaneous multiple primary colorectal cancer;
  • Preoperative imaging examination results show:
  • distant metastasis;
  • unable to perform R0 resection;
  • Postoperative pathology of T1-T2 N0;
  • History of any other malignant tumor in recent 5 years;
  • Patients need emergency operation: mechanic ileus, perforation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Drug CombinationsFolfox protocolNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsCombined Modality TherapyTherapeutics

Study Officials

  • Fumin Zhang, Professor

    Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital

    STUDY DIRECTOR

Central Study Contacts

Yueming Sun, PhD

CONTACT

02568136026jssym@vip.sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

August 29, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share