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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01605305

Enrollment

Registered

2012-05-24

Start date

2008-09-30

Completion date

2012-01-31

Last updated

2012-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

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

Interventions

DRUGFOLFOX6

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
TPP	from the first cycle of treatment (day one) to two month after the last cycle

Secondary

Measure	Time frame
OS	from the first cycle of treatment (day one) to two month after the last cycle

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026