NCT02291744

Brief Summary

The primary endpoint is to evaluate the TFS (time to failure of strategy).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

3 years

First QC Date

November 4, 2014

Last Update Submit

November 10, 2015

Conditions

Metastatic Colon Cancer

Keywords

TFS (time to failure of strategy)

Outcome Measures

Primary Outcomes (1)

  • TFS time of failure of strategy (the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment)

    the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment. The average time is three years.

Study Arms (2)

XELOX plus surgery

EXPERIMENTAL

Eight cycles of XELOX chemotherapy plus surgery:Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle. After 4 cycles, the patients are randomized to surgery group. Then the rest four cycles are administrated.

Procedure: resection of primary lesionDrug: XELOX

XELOX

ACTIVE COMPARATOR

Eight cycles of XELOX chemotherapy: Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle

Drug: XELOX

Interventions

resection of primary lesionPROCEDURE

Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle, and resection of primary lesion with metastatic colon cancer

XELOX plus surgery
XELOXDRUG

Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle,

XELOXXELOX plus surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \~75 ears old
  • Pathological diagnosis of colon cancer adenocarcinoma
  • No systemic chemotherapy for metastatic tumors
  • ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
  • At least one measurable objective tumor lesions
  • ANC≥1.5\*109/L；PLT≥90\*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤2.5ULN；Cr≤1.0(ULN) screening within 7 days
  • Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
  • Patients with voluntary participation, and sign the informed consent

You may not qualify if:

  • Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
  • With uncontrollable large pleural or peritoneal effusion
  • Alcohol or drug addictions
  • Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas
  • With brain metastasis
  • Multiple primary colorectal carcinoma
  • Pregnancy or breast-feeding women
  • There is an important organ failure or other serious diseases, including coronary artery disease, symptomatic cardiovascular disease or myocardial infarction within 12 months; serious neurological or psychiatric history; severe infection; actively disseminated vascula blood coagulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

  • Huang M, Yang Y, Li Q, Wang C, Liang L, Zhu X, Zhang W, Chen Z, Huang D, Li W, Zhang X, Zhao X, Qiu L, Geng Q, Yu N, Du W, Sun S, Sheng X, Li X, Guo W. Induction Chemotherapy Followed by Primary Tumor Resection Did Not Bring Survival Benefits in Colon Cancer Patients With Asymptomatic Primary Lesion and Synchronous Unresectable Metastases. Front Oncol. 2022 Jan 31;12:747124. doi: 10.3389/fonc.2022.747124. eCollection 2022.

    PMID: 35174078DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

XELOX

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Weijian Guo, doctor

CONTACT

13816066360mingzhuhuang0718@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 14, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations

CN(1)