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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01605305
• Other study ID #: FOLFOX6-2008
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2012
• Last updated: May 23, 2012
• Start date: September 2008
• Est. completion date: January 2012

Study information

• Verified date: May 2012
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• FOLFOX6
OXA 100mg/m2 ivgtt 2h d1 LV 400mg/m2 ivgtt 2h d1 5FU 400mg/m2 iv. d1 5FU 2.4g/m2 civ 46h

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TPP		from the first cycle of treatment (day one) to two month after the last cycle	No
Secondary	OS		from the first cycle of treatment (day one) to two month after the last cycle	No