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

Metastatic Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02291744
• Other study ID #: guoweijian-2014-XELOX
• Status: Recruiting
• Phase: Phase 2
• First received: November 4, 2014
• Last updated: November 10, 2015
• Start date: October 2014
• Est. completion date: October 2017

Study information

• Verified date: November 2015
• Source: Fudan University
• Contact: Weijian Guo, doctor
• Phone: 13816066360
• Email: mingzhuhuang0718[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Colon Cancer

Intervention

Procedure:
• resection of primary lesion
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

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

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	ShangHai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes