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

Fudan University0 sites60 target enrollmentSeptember 2008

ConditionsEsophageal Squamous Cell Carcinoma

InterventionsFOLFOX6

DrugsFOLFOX6

Overview

Phase: Phase 2
Intervention: FOLFOX6
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Fudan University
Enrollment: 60
Primary Endpoint: TPP
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

January 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Chang Jian Hua

associate chief physician

Fudan University

Eligibility Criteria

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
•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