Know Cancer

or
forgot password

A Randomized Study Of Continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st Line Advanced Colorectal Cancer


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

A Randomized Study Of Continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st Line Advanced Colorectal Cancer


Inclusion Criteria:



- Patients with histologically confirmed adenocarcinoma of the colon or rectum

- Unresectable metastases

- At least one bidimensionally measurable lesion of ≥ 1 cm

- No previous chemotherapy for metastatic disease; Completed at least more than 1 year
oxaliplatin therapy for adjuvant treatment

- 18-75 years old

- ECOG 0-2

- Life expectancy greater than 3 months

- Hemogram: WBC≥4.0 X109/L, ANC ≥2 X109/L, PLT ≥100 X109/L, Hb ≥90g/L,

- Adequate Renal Function

- Adequate Liver Function

- Signed informed consent before the treatment

Exclusion Criteria:

- Patients with previous oxaliplatin based adjuvant chemotherapy within 1 Year

- Completely or partially bowel obstruction

- Presence of peripheral neuropathy (CTC>grade I)

- Severe mental disorder

- CNS metastasis

- With other severe disease: uncontrolled active infectious disease, uncontrolled
hypertension, heart infarction within 1 year, uncontrolled high-risk arrhythmia,
unstable angina

- With other malignant disease previously or concurrently

- Receive other anti-tumor treatment

- Pregnant or lactating women, or women of child bearing potential without
contraceptive method.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

DDC: Duration of Disease Control

Outcome Time Frame:

Oct2012

Safety Issue:

Yes

Authority:

China: JiangSu Health Bureau

Study ID:

Oxali04882

NCT ID:

NCT01023633

Start Date:

October 2009

Completion Date:

July 2015

Related Keywords:

  • Colorectal Cancer
  • to investigate the efficacy and feasibility of this novel treatment strategy in Chinese mCRC patients
  • Primary Endpoint:DDC
  • Secondary Endpoint:OS, RR,DCR, PFS,safety
  • Colorectal Neoplasms

Name

Location