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Status unknownNCT00997685Updated Oct 19, 2009

Evaluate Efficacy and Safety of XELOX in Potentially Resectable Liver Metastasis From Colorectal Cancer(CRC)

A Phase 2 interventional study of Capecitabine plus oxaliplatin in Potentially Resectable Liver Metastasis From CRC and Colorectal Cancer, sponsored by Guangdong Provincial People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-10-19.

Sponsored by Guangdong Provincial People's Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
110
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a single arm, open-label phase II study to evaluate the efficacy and safety of Capecitabine plus oxaliplatin (XELOX) in the peri-operative treatment of patients with potentially resectable liver metastasis from colorectal cancer.

Read the detailed description

To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer

02

Conditions studied

  • Potentially Resectable Liver Metastasis From CRC
  • Colorectal Cancer

Keywords

  • XELOX
  • potentially resectable liver metastasis from CRC
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 110 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Guangdong Provincial People's Hospital is the lead sponsor of 237 studies on the registry; 102 are open to participants now.

Browse Guangdong Provincial People's Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age of 18 and 65
  • Histologically confirmed colorectal cancer and two methords of imaging detection confirmed liver metastasis
  • Potentially curable by resection, as determined by a surgeon with hepatic surgery expertise
  • No evidence of extrahepatic disease by chest x-ray or CT scan of the chest, abdomen, and pelvis
  • Patients with adequate hepative, renal and bone marrow function
  • Signed written informed consent

Exclusion criteria

Exclusion Criteria:

  • Pregnant or nursing patients (fertile patients must use effective contraception)
  • Other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix
  • Preexisting grade 2 or greater peripheral neuropathy
  • Concurrent uncontrolled illness
  • Ongoing or active infection
  • Psychiatric illness or social situation that would preclude study compliance
  • Less than 6 months since prior adjuvant fluorouracil-based chemotherapy
  • Prior chemotherapy for liver metastasis
  • Prior oxaliplatin for colorectal cancer
  • Prior or concurrent hepatic artery infusion chemotherapy for metastatic disease
  • Prior or concurrent radiotherapy for metastatic disease
  • Prior or concurrent radiofrequency ablation for metastatic disease
  • concurrent treatment with any other anti-cancer therapy.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Capecitabine plus oxaliplatin，mCRC

    Drug: Capecitabine plus oxaliplatin

Interventions

  • DrugCapecitabine plus oxaliplatin

    Drug pages: Capecitabine · Oxaliplatin

    Xeloda: 1000mg/m2 bid, d1-14, q3w, Oxaliplatin:130mg/m2 d1, q3w, 4 pre-operative cycles, 4 post-operative cycles

    Also known as: XELOX

06

What researchers measure

Primary outcomes

  1. To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer

    Time frame: 3.6 years

Secondary outcomes

  1. To investigate the response rate

    Time frame: 3.6 years

  2. To evaluate the R0 resection rate

    Time frame: 3.6 years

  3. To evaluate the safety profile of XELOX peri-operative treatment

    Time frame: 3.6 years

07

Study locations

1 site
  • Guangdong General Hospital
    Guangzhou, Guangdong 510080, China
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2009, a primary completion of Oct 2015 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2009
First posted
Oct 19, 2009
Start
Nov 2009
Primary completionEst.
Oct 2015
CompletionEst.
Oct 2015
Last update
Oct 19, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00997685
Lead sponsor
Guangdong Provincial People's Hospital
First posted
Oct 19, 2009
Start date
Nov 2009
Primary completion
Oct 2015 (estimated)
Completion
Oct 2015 (estimated)
Last update
Oct 19, 2009

Study contacts

Feng Lin, Dr
Contact
+8613903018609
Yong Li, Dr
Contact
yongyongsmart@yahoo.cn
+8613822177479
Feng Lin
principal investigator · Guangdong Provincial People's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Capecitabine · Oxaliplatin

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