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OpenTrials
Completed

NCT Number: NCT01605305

Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer

The aim of this study is to explore whether FOLFOX6 as treatment could improve the time to progression (TTP) and overall survival (OS) of the patient with recurrent or metastatic esophagus.

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Key information

About this study

Explore whether FOLFOX6 as treatment could improve the TTP and OS of the patient with recurrent or metastatic esophagus

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically proven primary thoracic esophageal squamous cell carcinoma
  • Without chemotherapy or neo-adjuvant chemotherapy in 6 weeks ,radiotherapy has end at least 1 month,target lesion was not in an irradiated area.
  • Presence of at least one index lesion measurable by CT scan or MRI
  • 18~75 years
  • kps ≥ 70
  • Life expectancy of ≥ 3 months
  • ANC ≥ 2×109/L,PLT ≥ 100×109/L,Hb ≥ 90g/L
  • Cr ≤ 1.0×UNL
  • TB ≤ 1.25×UNL; ALT/AST ≤ 2.5×UNL,THE patient with liver metastasis ALT/AST ≤ 5.0×UNL;AKP ≤ 2.5×UNL
  • Signed written informed consent

Exclusion criteria

  • Previous exposure to oxa therapy in one year
  • diameter of tumor abdominal ≥ 10cm, Total volumes of liver lesions ≥ 50%,lung metastasis ≥ 25% total lung
  • chronic diarrhea,enteritis,intestine obstruction which are not under control
  • Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.
  • peripheral neuropathy ≥ CTCAE 1
  • Other serious disease
  • Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry.
  • USE OTHER ANTITUMOR THERAPY
  • Breast-feeding or pregnant women, no effective contraception if risk of conception exists

Treatment and study plan

FOLFOX6

Drug

OXA 100mg/m2 ivgtt 2h d1 LV 400mg/m2 ivgtt 2h d1 5FU 400mg/m2 iv. d1 5FU 2.4g/m2 civ 46h

Primary outcomes

  1. TPP

    Time frame: from the first cycle of treatment (day one) to two month after the last cycle

Secondary outcomes

  1. OS

    Time frame: from the first cycle of treatment (day one) to two month after the last cycle

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Phase II Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
May 24, 2012
Registry last updated
May 24, 2012

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.

Published trials that share one or more normalized conditions with this study.