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CompletedNCT01605305Updated May 24, 2012

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

A Phase 2 interventional study of FOLFOX6 in Esophageal Squamous Cell Carcinoma, sponsored by Fudan University. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-05-24.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Esophageal Squamous Cell Carcinoma
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 460 are open to participants now.

This study's enrollment of 60 is close to the median of 58 across 1,170 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    FOLFOX6

    Drug: FOLFOX6

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

06

What researchers measure

Primary outcomes

  1. TPP

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

Secondary outcomes

  1. OS

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01605305
Lead sponsor
Fudan University
Responsible party
Chang Jian Hua (associate chief physician, Fudan University) — Principal investigator
First posted
May 24, 2012
Start date
Sep 2008
Primary completion
Jan 2012
Completion
Jan 2012
Last update
May 24, 2012

Study contacts

chang j h, post-doctor
principal investigator · Fudan University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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