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Completed

NCT Number: NCT03486379

Folfiri as Third Line of Treatment

The aim of this study is to investigate the activity of Folfiri as Third line of treatment in mGC progressed after ramuciramb-based second line.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Ramucirumab Stomach Diseases Stomach Neoplasms Third Line

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with histologically confirmed, ramucirumab pretreated metastatic gastric cancer who received
  • Eastern Cooperative Oncology Group performance status ≤2 (ECOG PS)
  • aged > 18 years
  • neutrophil count ≥1500/μl
  • platelet count ≥100 000/μl),
  • renal (serum creatinine ≤1.5 mg/dl)
  • liver (serum bilirubin ≤2 mg/dL) functions
  • normal cardiac function,
  • absence of second primary tumor other than non-melanoma skin cancer
  • no concurrent uncontrolled medical illness.

Exclusion criteria

  • Eastern Cooperative Oncology Group performance status >2 (ECOG PS)
  • No prior treatment with ramucirumab
  • operable metastatic disease were excluded from the study
  • severe cardiac dysfunction, congestive heart failure or a recent myocardial infarction
  • uncontrolled sites of infection.

Treatment and study plan

Primary outcomes

  1. response rate (confirmed complete and partial response).

    Time frame: From date of enrollment to best radiological evaluation, up to 12 months

    rate of patients with complete or partial response

Secondary outcomes

  1. Progression free survival

    Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

    Time from start of treatment to Progression or death

  2. Overall survival

    Time frame: From date of enrollment until the date of death from any cause, whichever came first, assessed up to 12 months

    Time from start of treatment to Death for any cause

  3. Toxicity

    Time frame: From date to start therapy up to 12 months

    Incidence of Toxicity according National Cancer Institute Common Terminology Criteria

Sponsors and collaborators

Lead sponsor

IRCCS Cancer Referral Center of Basilicata

Other

Registry information

Official study title

FOLFIRI as a Second-line Therapy in Patients With Docetaxel-pretreated Gastric Cancer

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 3, 2018
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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