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

NCT01193452 | Unknown Phase 2

• 1 other identifier: SL-eCRC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

elderly patients; advanced colorectal cancer; chemotherapy; S-1; 5-fluorouracil; leucovorin

Outcome Measures

Primary Outcomes (1)

• response rate

  six weeks

Secondary Outcomes (6)

• progression free survival

  six weeks

• disease control rate

  six weeks

• time to treatment failure

  six weeks

• overall survival

  three months

• quality of life

  six weeks

Study Arms (2)

S-1/LV

EXPERIMENTAL

S-1 combined with Leucovorin

Drug: S-1, Leucovorin

sLV5FU2

ACTIVE COMPARATOR

5-FU/LV infusion

Drug: leucovorin, 5-fluorouracil

Interventions

S-1, Leucovorin DRUG

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.

Also known as: chemotherapy

S-1/LV

leucovorin, 5-fluorouracil DRUG

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

Also known as: chemotherapy

sLV5FU2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Jin Li'

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

S 1 (combination); Leucovorin; Drug Therapy; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Therapeutics; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jin Li, MD,PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Li, MD,PhD

CONTACT

64175590

Wenhua Li, MS

CONTACT

64175590; whliiris@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 2, 2010
• Study Start: August 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2012
• Last Updated: September 2, 2010

Record last verified: 2010-08

Locations

CN (1)