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NCT Number: NCT00210184

Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer

The number of patients over 70 years old with cancer is increasing in France. This population is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a lot between subjects of the same age. Physicians hesitate to treat them with optimal doses because they are afraid of the risk of toxicity in spite of the benefits of treatment. Fifty eight percent of gastric cancers are diagnosed in patients over the age of 70 in France. FOLFIRI (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising treatment for digestive cancer. It increases the level of response and survival without major toxicity. It becomes necessary to evaluate patients, to propose adapted treatments for their conditions.

The principal objectives are to demonstrate the efficacy of treatment, safety, survival and to find out if geriatric assessment data can help to better predict chemotherapy toxicity. The researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic gastric cancer. They will receive FOLFIRI and 4 geriatric evaluations: before treatment, day 1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. These evaluations include tests of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL; IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

70 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 70 years of age or older
  • Gastric cancer, locally advanced or metastatic
  • No previous adjuvant treatment (surgery, radiotherapy, chemotherapy) in the last 6 months
  • One measurable lesion
  • ECOG < 3
  • Biology and biochemistry within normal limits
  • Life expectancy > 12 weeks

Exclusion criteria

  • Other palliative chemotherapy for this cancer
  • Other cancer in the last 5 years
  • Previous treatment with irinotecan
  • Atropine treatment not possible
  • Concomitant cancer therapy except bone radiotherapy
  • Metastases to brain or meninges with symptoms
  • Other severe pathology uncontrolled
  • Problem of compliance

Treatment and study plan

Irinotecan associated to fluorouracil and leucovorin

Drug

Primary outcomes

  1. 2-month Response Rate

    Time frame: 2 months

    Response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.

    Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).

Secondary outcomes

  1. Overall Survival

    Time frame: From date of inclusion until the date of date of death from any cause, assessed up to 12 months.

    OS was defined as the time from trial inclusion to death due to any cause. Participants without documented death were censored at the date of the last follow-up or last patient contact. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.

  2. Progression-free Survival

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

    PFS was defined as time since trial inclusion to progression or death from any cause, whichever occurred first, and data from patients progression-free and lost to follow-up before the study end were censored at date of last news. The PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Collaborators

  • Aventis Pharmaceuticals
  • Novartis
  • Sanofi-Synthelabo

Registry information

Official study title

Multicentric Phase II Trial: Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years Old and More Presenting Gastric Cancer Locally Advanced or Metastatic

Acronym: CEPAFIRI

Important dates

Study start
2004
Primary completion
2009
Study completion
2010
First posted
Sep 21, 2005
Registry last updated
Oct 6, 2021

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

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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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