Radiation Dose Study of Concurrent Chemoradiotherapy With Cisplatin Plus Fluorouracil in Oesophageal Cancer
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Jiangsu
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Nanjing, Jiangsu, Kina, 210029
- Jiangsu Province Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Biopsy-proven squamous cell carcinoma or adenocarcinoma of thoracic or cervical esophagus or gastroesophageal junction esophagus, including the gastroesophageal junction
- Measurable lesion
- Age > 18 years
- Karnofsky performance score > 70
- Life expectancy > 3 months
- 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:
- Prior systemic chemotherapy for EC
- Evidence of distant metastatic disease
- Evidence of uncontrolled medical conditions (e.g.,serious infection,grade 4 hypertension,congestive heart failure)
- A history of concomitant or previous malignancy.
- Physical evidence of peripheral neuropathy or hearing loss
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Concurrent radiochemotherapy
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initial dose:50Gy/2Gy/25f,5days/week escalation dose:4Gy/2Gy/2f
cisplatin 75 mg/m2 on day 1 with standard hydration fluorouracil 1000 mg/m2/day1 i.v. by continuous infusion from day 1 to day 4 of each cycle
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Objective Tumor Response
Tidsram: One day after completion of the initial therapeutic dose (50.0Gy) and the total dose of radiotherapy
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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.
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One day after completion of the initial therapeutic dose (50.0Gy) and the total dose of radiotherapy
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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adverse events
Tidsram: Side effect assessment was performed every week for the duration of concurrent radiochemotherapy, an expected average of 5 weeks
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using the National Cancer Institute Common Toxicity Criteria,predominantly observe the presence of radiation esophagitis,radiaion pneumonia and hematological toxicity.
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Side effect assessment was performed every week for the duration of concurrent radiochemotherapy, an expected average of 5 weeks
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Xinchen Sun, M.D.,Ph.D., The First Affiliated Hospital with Nanjing Medical University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Neoplasmer i huvud och hals
- Esofagussjukdomar
- Esofagusneoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Fluorouracil
Andra studie-ID-nummer
- JSNT0415
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