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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Esophageal Squamous Cell Carcinoma

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

TPP

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

chang j h, post-doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

FOLFOX6-2008

NCT ID:

NCT01605305

Start Date:

September 2008

Completion Date:

January 2012

Related Keywords:

  • Esophageal Squamous Cell Carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms

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