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Impact of Adjuvant FOLFOX on Quality of Life and Sensory Neurotoxicity in Patients With Advanced Gastric Cancer

P

Pontificia Universidad Catolica de Chile

Status

Unknown

Conditions

Stomach Neoplasms

Treatments

Other: Quality of life assessment

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

The primary objective of this trial is to determine the impact of the FOLFOX regimen on quality of life and the incidence of chemotherapy induced neurotoxicity.

Full description

Gastric cancer is one of the main cancer-related causes of death in the world. There is more than one standard treatment for non-metastatic advanced disease. Among the therapeutic alternatives there is high level of evidence to recommend surgery followed by chemoradiotherapy or chemotherapy and for perioperative chemotherapy. These strategies have not been compared in adequate powered trials, so there are important regional differences in their use. Postoperative chemotherapy with oxaliplatin based chemotherapy may offer some advantages in limited resource settings, because of its lower logistic requirements and it could be specially useful in centers with high quality surgery. On the other hand one of its most important downsides could be a higher impact on quality of life particularly related to oxaliplatin induced neuropathy which can last long after the end of treatment. This is a prospective observational trial in which after consent subjects are going to be evaluated with the EORTC (European Organization for Research and Treatment of Cancer) questionnaires C30 and CIPN20 during FOLFOX (5-fluorouracil/leucovorin with oxaliplatin) adjuvant treatment.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of gastric adenocarcinoma
  • ECOG (Eastern Cooperative Oncology Group) functional status of 0 or 1
  • Treated with surgery with curative intent
  • TNM stage II - III or TNM stage I with positives lymph nodes

Exclusion criteria

  • Surgery with microscopical or macroscopical residual tumour
  • Adjuvant chemotherapy refusal
  • ECOG functional status of 2 or more
  • Previous peripheral neuropathy
  • Significant cardiovascular disease or other organ disfunction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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