Clinical trial · Interventional
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
NCT01605305CI-TRIAL-00006986completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOX6 | Drug | FOLFOX-6 Regimen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFOX6
- interventionNames
- Drug: FOLFOX6
Primary outcomes (1)
- measure
- TPP
- timeFrame
- from the first cycle of treatment (day one) to two month after the last cycle
Secondary outcomes (1)
- measure
- OS
- timeFrame
- from the first cycle of treatment (day one) to two month after the last cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.