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A Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients

Primary Purpose

Metastatic Colon Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
resection of primary lesion
XELOX
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colon Cancer focused on measuring TFS (time to failure of strategy)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18~75 ears old
  2. Pathological diagnosis of colon cancer adenocarcinoma
  3. No systemic chemotherapy for metastatic tumors
  4. ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
  5. At least one measurable objective tumor lesions
  6. 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
  7. Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
  8. Patients with voluntary participation, and sign the informed consent

Exclusion Criteria:

  1. Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
  2. With uncontrollable large pleural or peritoneal effusion
  3. Alcohol or drug addictions
  4. 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
  5. With brain metastasis
  6. Multiple primary colorectal carcinoma
  7. Pregnancy or breast-feeding women
  8. 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.

Sites / Locations

  • Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

XELOX plus surgery

XELOX

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
November 4, 2014
Last Updated
November 10, 2015
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02291744
Brief Title
A Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients
Official Title
A Randomized Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients With Unresectable Metastatic Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary endpoint is to evaluate the TFS (time to failure of strategy).
Detailed Description
The primary endpoint is to evaluate the time to failure of strategy, that is the second progression time after induction therapy by the use of XELOX regimen, comparing XELOX regimen chemotherapy combined with or without surgical resection of the primary lesion from the time of randomization to maintenance therapy and reapplication of induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colon Cancer
Keywords
TFS (time to failure of strategy)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XELOX plus surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
XELOX
Arm Type
Active Comparator
Arm Description
Eight cycles of XELOX chemotherapy: Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
Intervention Type
Procedure
Intervention Name(s)
resection of primary lesion
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
XELOX
Intervention Description
Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle,
Primary Outcome Measure Information:
Title
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)
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18~75 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weijian Guo, doctor
Phone
13816066360
Email
mingzhuhuang0718@163.com
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
ShangHai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Jian Guo, PHD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35174078
Citation
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.
Results Reference
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A Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients

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