Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer
NCT ID: NCT01605305
Last Updated: 2012-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2008-09-30
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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FOLFOX6
FOLFOX6
OXA 100mg/m2 ivgtt 2h d1 LV 400mg/m2 ivgtt 2h d1 5FU 400mg/m2 iv. d1 5FU 2.4g/m2 civ 46h
Interventions
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FOLFOX6
OXA 100mg/m2 ivgtt 2h d1 LV 400mg/m2 ivgtt 2h d1 5FU 400mg/m2 iv. d1 5FU 2.4g/m2 civ 46h
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Chang Jian Hua
associate chief physician
Principal Investigators
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chang j h, post-doctor
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Other Identifiers
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FOLFOX6-2008
Identifier Type: -
Identifier Source: org_study_id
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