Clinical trial · Interventional
Neoadjuvant Paclitaxel Poliglumex, Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial (CTI#X64001)
BrUOG-E-215-Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001
NCT00522795CI-TRIAL-00043458completedPhase 2Results postedClinicalTrials.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)
Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001
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 Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PPX with cisplatin and radiation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PPX with cisplatin and radiation
- description
- PPX 50mg/m2 wk and cisplatin 25mg/m2 wk for 6 weeks with 50.4 GY concurrent radiation
- interventionNames
- Drug: PPX with cisplatin and radiation
Primary outcomes (1)
- measure
- Complete Pathologic Response
- timeFrame
- At Surgery approximately 4weeks after last treatment
- description
- Per pathology review post surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction * Patients may have celiac adenopathy * There must be no evidence of distant organ metastases * No prior chemotherapy or radiation for esophageal cancer * Patients must be \> 18 years of age, and non pregnant * Patients must have an ANC \> 1,500/ul, platelets \> 100,000/ul, creatinine \< 2.0 and bilirubin \< 1.5 x ULN-ECOG performance status 0-1. * Female patients, must either be not of child bearing potential or have a negative pregnancy test within 14 days of starting study treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Pregnant or lactating females are not eligible * No contraindications to esophagectomy * Signed informed consent Exclusion Criteria: * Active or uncontrolled infection * Patients must not have other coexistent medical condition that would preclude protocol therapy. * Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
References
Publications (0)
Data not yet available
No reference posted for this study.