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

Phase 2

Completed

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: FOLFOX6

• Registration Number: NCT01605305
• Lead Sponsor: Fudan University

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

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-05
• Study First Submitted: 2012-05-22
• Study First Submitted QC: 2012-05-23
• Last Update Submitted: 2012-05-23
• Study First Posted: 2012-05-24
• Last Update Posted: 2012-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Histologically proven primary thoracic esophageal squamous cell carcinoma
2. Without chemotherapy or neo-adjuvant chemotherapy in 6 weeks ,radiotherapy has end at least 1 month,target lesion was not in an irradiated area.
3. Presence of at least one index lesion measurable by CT scan or MRI
4. 18~75 years
5. kps ≥ 70
6. Life expectancy of ≥ 3 months
7. ANC ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L
8. Cr ≤ 1.0×UNL
9. TB ≤ 1.25×UNL； ALT/AST ≤ 2.5×UNL，THE patient with liver metastasis ALT/AST ≤ 5.0×UNL；AKP ≤ 2.5×UNL
10. Signed written informed consent

Exclusion Criteria

1. Previous exposure to oxa therapy in one year
2. diameter of tumor abdominal ≥ 10cm, Total volumes of liver lesions ≥ 50%,lung metastasis ≥ 25% total lung
3. chronic diarrhea,enteritis,intestine obstruction which are not under control
4. Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.
5. peripheral neuropathy ≥ CTCAE 1
6. Other serious disease
7. 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.
8. USE OTHER ANTITUMOR THERAPY
9. Breast-feeding or pregnant women, no effective contraception if risk of conception exists

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FOLFOX6	FOLFOX6	-

Primary Outcome Measures

Name	Time	Method
TPP	from the first cycle of treatment (day one) to two month after the last cycle

Secondary Outcome Measures

Name	Time	Method
OS	from the first cycle of treatment (day one) to two month after the last cycle