Clinical trial · Interventional
S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer
Phase I Study of S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer
NCT01175460CI-TRIAL-00006378completedPhase 1ClinicalTrials.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)
Patients with advanced esophageal cancer will receive thoracic radiation therapy 60Gy over 30 fractions,and concurrent with s-1 and nedaplatin.
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 |
|---|---|---|---|
| S-1, Nedaplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemoradiotherapy
- description
- Thoracic radiation 60Gy over 30 fractions.Concurrently, nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 was given on Days 1-14,repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.
- interventionNames
- Drug: S-1, Nedaplatin
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) of s-1 in combination with nedaplatin and thoracic radiotherapy
- timeFrame
- 3 months per patient
- description
- the MTD will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) during treatment.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic proof of primary squamous cell or adenocarcinoma of the esophagus * Locoregionally advanced carcinoma of esophagus without systemic metastases * Zubrod Performance Status 0-1; * Patients ≥ 18 years of age; * No hypersensitivity to E. coli -derived products; * AGC ≥ 1500/mm3, platelets ≥ 150,000/mm3, Hgb ≥ 10 gm%, serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 65 cc/min; serum calcium ≤ 11gm/dl; * Patients with prior malignancy are eligible if curable non-melanoma skin cancer or cervical cancer in situ or disease free ≥ 5 years; * No prior chest or upper abdomen radiotherapy; no prior systemic chemotherapy within the past 5 years; no prior esophageal or gastric surgery; * Written informed consent. Exclusion Criteria: * Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi. * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible). * Prior systemic chemotherapy or radiation therapy for esophageal cancer
References
Publications (0)
Data not yet available
No reference posted for this study.