Know Cancer

forgot password

A Randomized Phase III Study of SOX vs. COX in Patients With Advanced Colorectal Cancer

Phase 3
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

A Randomized Phase III Study of SOX vs. COX in Patients With Advanced Colorectal Cancer

- The urgent need for new effective therapy with better safety profile for metastatic
colorectal cancer patients and promising results observed so far in trials with S-1
combined with oxaliplatin in gastrointestinal cancer including colorectal cancer
strongly warrants the comparison of S-1 combined with oxaliplatin to capecitabine
combination with oxaliplatin acknowledged as a standard regimen in a first-line
treatment for advanced colorectal cancer patients.

- Recently, a Phase I study was completed, indicating recommended dose as S-1 100
mg/m2/day1-14 and oxaliplatin (130 mg/m2/day1), repeated every 3 weeks. However, in the
phase II study using the above recommended dose, delayed toxicities of thrombocytopenia
and anemia were observed. These delayed toxicities were also reported in a phase II
study using S-1 90 mg/m2/day plus oxaliplatin 130 mg/m2/day1 in advanced gastric
cancer. At 2007 GI ASCO, the interim data of S-1(80 mg/m2/day1-14) plus oxaliplatin
(130 mg/m2/day1) combination, repeated every 3 weeks, was presented, showing promising
antitumor activity with favourable safety profile. Among 18 patients, there were only
two patients with Grade 3 thrombocytopenia and one with Grade 3 neutropenia. Response
rate was 57.1 % and disease control rate was 92.9 %. Considering these results and
Japanese data which showed that enhanced efficacy was not observed with S-1 over 90
mg/m2/day and oxaliplatin combination, S-1 80 mg/m2/day 1-14 and oxaliplatin 130
mg/m2/D1, repeated every 3 weeks, will be tested in this study.

Inclusion Criteria:

- Histologically documented colorectal adenocarcinoma

- Age over 18 years old

- Performance status (ECOG scale): 0-2

- Measurable or evaluable disease

- Patients can take food and drugs orally

- Adequate organ functions

- Life expectancy ≥ 3 months

- Patients should sign a written informed consent before study entry

Exclusion Criteria:

- Tumor type other than adenocarcinoma

- Second primary malignancy

- Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive
immunotherapy) for advanced or metastatic colorectal cancer

- Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease has been completed
within 6 months prior to initiation of study treatment.

- Prior radiotherapy was administered to target lesions selected for this study, or
radiotherapy to the non-target lesions has been completed within 4 weeks before

- Presence of CNS metastasis

- Obvious peritoneal seeding or bowel obstruction disturbing oral intake

- Symptomatic peripheral neuropathy

- Major surgery within 4 weeks prior to study treatment start, or lack of complete
recovery from the effects of major surgery. The patient received curative operation
or RFA for metastatic disease.

- Serious illness or medical conditions

- Receiving a concomitant treatment with drugs interacting with S-1, capecitabine or
oxaliplatin, as follows;flucytosine, a fluorinated pyrimidine antifungal agent
phenytoin warfarin etc.

- Received any investigational drug or agent/procedure, i.e. participation in another
trial within 4 weeks before beginning treatment with study drug.

- Pregnant or lactating woman

- Women of child bearing potential not using a contraceptive method

- Sexually active fertile men not using effective birth control during medication of
study drug and up to 6 months after completion of study drug if their partners are
women of child-bearing potential

- Any patients judged by the investigator to be unfit to participate in the study

Type of Study:


Study Design:

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

Outcome Measure:

To compare the combination of S-1 and oxaliplatin to the combination of capecitabine and oxaliplatin in terms of progression free survival in patients previously untreated by systemic therapy for advanced or metastatic colorectal carcinoma.

Outcome Time Frame:

9 months

Safety Issue:


Principal Investigator

Young Suk Park, M.D.,Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Samsung Medical Center, Seoul, Korea


Korea: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

January 2011

Related Keywords:

  • Colorectal Cancer
  • metastatic colorectal cancer
  • S-1
  • Capecitabine
  • Oxaliplatin
  • non-inferiority study
  • Colorectal Neoplasms