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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01605305
First Posted: May 24, 2012
Last Update Posted: May 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chang Jian Hua, Fudan University
  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 (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:


Further study details as provided by Chang Jian Hua, Fudan University:

Primary Outcome Measures:
  • TPP [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ]

Secondary Outcome Measures:
  • OS [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605305


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

Responsible Party: Chang Jian Hua, associate chief physician, Fudan University
ClinicalTrials.gov Identifier: NCT01605305     History of Changes
Other Study ID Numbers: FOLFOX6-2008
First Submitted: May 22, 2012
First Posted: May 24, 2012
Last Update Posted: May 24, 2012
Last Verified: May 2012

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