18 Years
N/A
Both
Esophageal Neoplasms
Trial Information
Esophageal cancer (EC) continues to be a major health burden worldwide. The 5-year survival
rates for esophageal cancer have remained less than 15% over decades, probably because of
ineffective therapies and the detection of late-stage cancers. Concurrent chemo-radiotherapy
was established as one of the viable options for therapy of patients with localized EC
following the results from the landmark trial of the Radiation Therapy Oncology Group (RTOG)
85-01 trial, showing a significant survival advantage of concurrent chemoradiation over
radiation alone.
The use of radiochemotherapy with cisplatin and 5-fluorouracil (5-FU) is a well-accepted
standard for the definitive treatment of esophageal cancer in China which has also been
demonstrated efficacy and good tolerability internationally. The AJCC recommended dose range
of radiotherapy for concurrent therapy is 45-50.4Gy. Moreover, (RTOG) 85-01 trial also
established 50.4 Gy as the standard dose of radiation to be administered concurrently with
chemotherapy. However, the appropriate dose of radiation fit for Chinese remains
controversial. Due to insufficient evidence of EBM, radiation therapist in China always
prescribe a radiation dosage by their own experience. Dosages (e.g. 60-64Gy) significantly
higher than the international standard is commonly used in Chinese EC patients which lead to
a greater likelihood of toxicity. Thus Chinese oncologists are urgent to reach a consensus
about radiation dosage in the standard treatment of local advanced EC.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Outcome Measure:
Objective Tumor Response
Outcome 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.
Outcome Time Frame:
One day after completion of the initial therapeutic dose (50.0Gy) and the total dose of radiotherapy
Safety Issue:
No
Principal Investigator
Xinchen Sun, M.D.,Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jiangsu Province Hospital
Authority:
China: Ethics Committee
Study ID:
JSNT0415
NCT ID:
NCT01646853
Start Date:
August 2012
Completion Date:
Related Keywords:
- Esophageal Neoplasms
- Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
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