S-1/Leucovorin (SL) Versus sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01193452
First received: August 31, 2010
Last updated: September 1, 2010
Last verified: August 2010
  Purpose

This phase II trial on the assumption that S-1 combined with Leucovorin may have better efficacy and safety than simplified 5-FU/LV infusion therapy in elderly patients with advanced colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: S-1, Leucovorin
Drug: leucovorin, 5-fluorouracil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Comparing S-1/Leucovorin With sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • response rate [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: six weeks ] [ Designated as safety issue: No ]
  • disease control rate [ Time Frame: six weeks ] [ Designated as safety issue: No ]
  • time to treatment failure [ Time Frame: six weeks ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: three months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-1/LV
S-1 combined with Leucovorin
Drug: S-1, Leucovorin

S-1 :

The initial dosage of S-1 is determined by the body surface area:

Surface area: 1.25-1.5 m2 : 50mg twice per day;upper than 1.5 m2 : 60mg twice per day

Leucovorin:

25mg twice per day po.

The treatment is given for one week,and no chemotherapy is given for the following one week.

Other Name: chemotherapy
Active Comparator: sLV5FU2
5-FU/LV infusion
Drug: leucovorin, 5-fluorouracil

leucovorin: 400mg/m2 intravenous infusion d1;

5-fluorouracil: 400mg/m2 intravenous push,d1; 2400mg/m2 continuous intravenous infusion for 46 hours

repeat every 2 weeks

Other Name: chemotherapy

Detailed Description:

This is a randomized phase Ⅱ study, in which S-1 is used in combination with leucovorin in elderly patients with advanced colorectal cancer as first-line treatment,comparing with sLV5FU2 therapy. The aim of this study is to determine the efficacy and safety of S-1/LV in elderly patients in the first-line setting. The other secondary endpoints are progression free survival,overall survival, and quality of life are also evaluated.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Oral medication is acceptable
  • Histologically confirmed colorectal carcinoma
  • Male or female ≥ 65 years of age
  • No prior chemotherapy,radiotherapy,target therapy and immunotherapy, except adjuvant chemotherapy with an interval of ≥ 180 days)
  • Presence of at least one target lesion measurable by CT scan or MRI,within 15 days prior to trial
  • The lab values within 2 weeks prior to trial should meet:

PLT ≥7.5*10^4/mm3 ANC≥2000/mm3 HB≥100g/L Total bilirubin < upper limit of normal level ALT/AST/ALP < 2.5 x UNL (<5 x UNL for patients with liver or bone metastasis) Serum creatinine < UNL

  • Performance status (ECOG) 0~1
  • Life expectation longer than 90 days

Exclusion Criteria:

  • Allergy to S-1,fluorouracil or leucovorin
  • Any investigational agent(s) within 4 weeks prior to entry
  • Previous or currently exposure to certain drugs which are proved to have influence on blood drug concentration
  • Active infection
  • Severe organ failures or diseases, including: intestinal obstruction, pulmonary fibrosis, uncontrolled diabetes mellitus,clinically relevant coronary disease, cardiovascular disorder or myocardial infarction,renal or liver failure, severe psychiatric illness,cerebral vascular disease and sever GI ulcer which need blood infusion.
  • Uncontrolled hydrothorax,ascites and hydropericardium
  • Multiple bone metastatic lesions
  • Brain metastases
  • Chronic diarrhea or digestive disfunction
  • Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
  • Strong willingness to receive surgery or highly potential to have intestinal obstruction which may need surgery intervention
  • Other conditions that primary investigate or investigator consider to be unsuitable for the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193452

Contacts
Contact: Jin Li, MD,PhD 64175590 ext 5100
Contact: Wenhua Li, MS 64175590 ext 8900 whliiris@hotmail.com

Locations
China, Shanghai
Jin Li` Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jin Li, MD,PhD    8621 64175590 ext 5100      
Contact: Wenhua Li, MS    862164175590 ext 8900    whliiris@hotmail.com   
Sub-Investigator: Wen Zhang         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jin Li, MD,PhD Fudan University
  More Information

No publications provided

Responsible Party: Jin Li, Fudan University Shanghai Cancer Center
ClinicalTrials.gov Identifier: NCT01193452     History of Changes
Other Study ID Numbers: SL-eCRC
Study First Received: August 31, 2010
Last Updated: September 1, 2010
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
elderly patients
advanced colorectal cancer
chemotherapy
S-1
5-fluorouracil
leucovorin

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014