Clinical trial · Interventional
Radiation Dose Study of Concurrent Chemoradiotherapy With Cisplatin Plus Fluorouracil in Oesophageal Cancer
NCT01646853CI-TRIAL-00007516unknownN/AClinicalTrials.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 objective of this study is to determine the optimal radiation dosage used in concurrent chemo-radiotherapy in Chinese population. A dose climbing experiment is carried out with an initiate dose of 50Gy conventionally applied in Western countries.
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 Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin-fluorouracil chemotherapy | Drug | — | UNRESOLVED |
| Megavoltage photon beam | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Concurrent radiochemotherapy
- interventionNames
- Radiation: Megavoltage photon beam
- Drug: cisplatin-fluorouracil chemotherapy
Primary outcomes (1)
- measure
- Objective Tumor Response
- timeFrame
- One day after completion of the initial therapeutic dose (50.0Gy) and the total dose of radiotherapy
- description
- objective evaluation is made according to the standards of Response Evaluation Criteria in Solid Tumors (RECIST)，defined as complete response(CR),partial response (PR)，stable disease(SD),and progressive disease (PD).Tumor sizes are measured using barium esophagram or CT.
Secondary outcomes (1)
- measure
- adverse events
- timeFrame
- Side effect assessment was performed every week for the duration of concurrent radiochemotherapy, an expected average of 5 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Biopsy-proven squamous cell carcinoma or adenocarcinoma of thoracic or cervical esophagus or gastroesophageal junction esophagus, including the gastroesophageal junction 2. Measurable lesion 3. Age \> 18 years 4. Karnofsky performance score \> 70 5. Life expectancy \> 3 months 6. Adequate bone marrow function (white blood cell \[WBC\] count ≥ 3.5 109/L, neutrophil count ≥ 2.0 109/L, and platelet count ≥ 100 109/L), adequate renal function (creatinine ≤ 2 mg/dL or creatinine clearance ≥ 50 mL/min), and normal liver function (aspartate aminotransferase and alanine aminotransferase less than two times the upper limit of normal, total serum bilirubin ≤ 1.5 mg/dL). Exclusion Criteria: 1. Prior systemic chemotherapy for EC 2. Evidence of distant metastatic disease 3. Evidence of uncontrolled medical conditions (e.g.,serious infection,grade 4 hypertension,congestive heart failure) 4. A history of concomitant or previous malignancy. 5. Physical evidence of peripheral neuropathy or hearing loss
References
Publications (0)
Data not yet available
No reference posted for this study.