Radiation Dose Study of Concurrent Chemoradiotherapy With Cisplatin Plus Fluorouracil in Oesophageal Cancer
|ClinicalTrials.gov Identifier: NCT01646853|
Recruitment Status : Unknown
Verified July 2012 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was: Not yet recruiting
First Posted : July 20, 2012
Last Update Posted : July 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Neoplasms||Radiation: Megavoltage photon beam Drug: cisplatin-fluorouracil chemotherapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||December 2013|
|Experimental: Concurrent radiochemotherapy||
Radiation: Megavoltage photon beam
initial dose:50Gy/2Gy/25f,5days/week escalation dose:4Gy/2Gy/2fDrug: cisplatin-fluorouracil chemotherapy
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
Other Name: PF chemotherapy
- Objective Tumor Response [ Time Frame: One day after completion of the initial therapeutic dose (50.0Gy) and the total dose of radiotherapy ]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.
- adverse events [ Time Frame: Side effect assessment was performed every week for the duration of concurrent radiochemotherapy, an expected average of 5 weeks ]using the National Cancer Institute Common Toxicity Criteria,predominantly observe the presence of radiation esophagitis,radiaion pneumonia and hematological toxicity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646853
|Contact: Xinchen Sun, M.D.,Ph.D.||+email@example.com|
|Jiangsu Province Hospital|
|Nanjing, Jiangsu, China, 210029|
|Principal Investigator:||Xinchen Sun, M.D.,Ph.D.||The First Affiliated Hospital with Nanjing Medical University|