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

• Sponsor: Fudan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01605305
• Collaborator: (none)
• Enrollment: 60
• Arm: 1
• Duration (Months): 40

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Drug: FOLFOX6	Phase 2

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Phase II Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FOLFOX6	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

Outcome Measures

Primary Outcome Measures

1. TPP [from the first cycle of treatment (day one) to two month after the last cycle]

Secondary Outcome Measures

1. OS [from the first cycle of treatment (day one) to two month after the last cycle]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Fudan University

Investigators

• Principal Investigator: chang j h, post-doctor, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang Jian Hua, associate chief physician, Fudan University
• ClinicalTrials.gov Identifier: NCT01605305
• Other Study ID Numbers: FOLFOX6-2008
• First Posted: May 24, 2012
• Last Update Posted: May 24, 2012
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma

Study Results

No Results Posted as of May 24, 2012