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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Jian Hua, Fudan University
ClinicalTrials.gov Identifier:
NCT01605305
First received: May 22, 2012
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Esophageal Squamous Cell Carcinoma
 Drug: FOLFOX6
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • TPP [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • OS [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605305

Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: chang j h, post-doctor Fudan University
  More Information

No publications provided

Responsible Party: Chang Jian Hua, associate chief physician, Fudan University
ClinicalTrials.gov Identifier: NCT01605305     History of Changes
Other Study ID Numbers: FOLFOX6-2008
Study First Received: May 22, 2012
Last Updated: May 23, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Diseases
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013