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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

FOLFOX6

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FOLFOX6

Arm Description

Outcomes

Primary Outcome Measures

TPP

Secondary Outcome Measures

Full Information

NCT ID

NCT01605305

First Posted

May 22, 2012

Last Updated

May 23, 2012

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01605305

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FOLFOX6

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

FOLFOX6

Intervention Description

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

Primary Outcome Measure Information:

Title

TPP

Time Frame

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

Secondary Outcome Measure Information:

Title

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

chang j h, post-doctor

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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