Definitive Concurrent Chemoradiotherapy With Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin in Patients With Esophageal Squamous Cell Carcinoma
NCT ID: NCT02969473
Last Updated: 2016-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2010-10-31
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PF group
This is the active comparator group. All patients in this group will receive concurrent chemoradiotherapy with PF regimen (5-fluorouracil plus cisplatin).
Fluorouracil
Radiotherapy: All patients underwent conventional radiotherapy, 1.8-2.0 Gy per fraction and 5 fractions per week. The prescribed dose was 60-64 Gy to PTV1 and 50 Gy to PTV2. Patients received either three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiation therapy (IMRT). 3D-CRT treatment plans were calculated by Pinnacle planning system and IMRT treatment plans were calculated by Monacle planning system. All patients were treated with a 6-MV or 8-MV linear accelerator.
Chemotherapy: All patients received two cycles of chemotherapy concurrently with radiotherapy. Patients assigned to the PF group received two cycles of PF regimen (cisplatin 80 mg/m2 delivered on day 1 and 5-FU 1000 mg/m2 continuous infusion over 24 hours daily on days 1-4) at a 3-week interval. In cases of grade 4 hematologic toxicity or severe non-hematologic toxicities, dose adjustment was performed in the subsequent chemotherapy cycle.
DP group
This is the experimental group. All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).
Docetaxel
Radiotherapy: All patients underwent conventional radiotherapy, 1.8-2.0 Gy per fraction and 5 fractions per week. The prescribed dose was 60-64 Gy to PTV1 and 50 Gy to PTV2. Patients received either three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiation therapy (IMRT). 3D-CRT treatment plans were calculated by Pinnacle planning system and IMRT treatment plans were calculated by Monacle planning system. All patients were treated with a 6-MV or 8-MV linear accelerator.
Chemotherapy: All patients received two cycles of chemotherapy concurrently with radiotherapy. Patients assigned to the DP group received two cycles of DP regimen (docetaxel 60 mg/m2 delivered on day 1 and cisplatin 80 mg/m2 delivered on day 1) at a 3-week interval. In cases of grade 4 hematologic toxicity or severe non-hematologic toxicities, dose adjustment was performed in the subsequent chemotherapy cycle.
Interventions
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Docetaxel
Radiotherapy: All patients underwent conventional radiotherapy, 1.8-2.0 Gy per fraction and 5 fractions per week. The prescribed dose was 60-64 Gy to PTV1 and 50 Gy to PTV2. Patients received either three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiation therapy (IMRT). 3D-CRT treatment plans were calculated by Pinnacle planning system and IMRT treatment plans were calculated by Monacle planning system. All patients were treated with a 6-MV or 8-MV linear accelerator.
Chemotherapy: All patients received two cycles of chemotherapy concurrently with radiotherapy. Patients assigned to the DP group received two cycles of DP regimen (docetaxel 60 mg/m2 delivered on day 1 and cisplatin 80 mg/m2 delivered on day 1) at a 3-week interval. In cases of grade 4 hematologic toxicity or severe non-hematologic toxicities, dose adjustment was performed in the subsequent chemotherapy cycle.
Fluorouracil
Radiotherapy: All patients underwent conventional radiotherapy, 1.8-2.0 Gy per fraction and 5 fractions per week. The prescribed dose was 60-64 Gy to PTV1 and 50 Gy to PTV2. Patients received either three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiation therapy (IMRT). 3D-CRT treatment plans were calculated by Pinnacle planning system and IMRT treatment plans were calculated by Monacle planning system. All patients were treated with a 6-MV or 8-MV linear accelerator.
Chemotherapy: All patients received two cycles of chemotherapy concurrently with radiotherapy. Patients assigned to the PF group received two cycles of PF regimen (cisplatin 80 mg/m2 delivered on day 1 and 5-FU 1000 mg/m2 continuous infusion over 24 hours daily on days 1-4) at a 3-week interval. In cases of grade 4 hematologic toxicity or severe non-hematologic toxicities, dose adjustment was performed in the subsequent chemotherapy cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* stage II-IVA disease, including metastatic celiac or cervical nodes, according to the sixth edition of American Joint Committee on Cancer (AJCC) staging system for esophageal cancer
* aged between 18 and 70 years
* Karnofsky Performance Status (KPS) score ≥ 70
* adequate bone marrow function (leukocyte count ≥ 4000/uL, platelet count ≥ 100,000/uL), adequate liver function (serum alanine aminotransferase (ALT) level and serum aspartate aminotransferase (AST) level \< twice the upper limit of normal, and serum bilirubin level of \<1.5 mg/dL), and adequate renal function (creatinine clearance ≥ 50 mL/min)
* no other serious medical conditions
* life expectancy ≥ 3 months
* written informed consent
Exclusion Criteria
* known allergy to CDDP, 5-FU, or docetaxel
* pregnancy or breast feeding
18 Years
70 Years
ALL
No
Sponsors
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Zhu Yujia
OTHER
Responsible Party
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Zhu Yujia
MD
Principal Investigators
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Yonghong Hu, MD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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SYSU Cancer Center
Guangzhou, Guangdong, China
Countries
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References
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Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002 Mar 1;20(5):1167-74. doi: 10.1200/JCO.2002.20.5.1167.
Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623.
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Gaspar LE, Winter K, Kocha WI, Coia LR, Herskovic A, Graham M. A phase I/II study of external beam radiation, brachytherapy, and concurrent chemotherapy for patients with localized carcinoma of the esophagus (Radiation Therapy Oncology Group Study 9207): final report. Cancer. 2000 Mar 1;88(5):988-95.
Minsky BD, Neuberg D, Kelsen DP, Pisansky TM, Ginsberg R, Benson A 3rd. Neoadjuvant chemotherapy plus concurrent chemotherapy and high-dose radiation for squamous cell carcinoma of the esophagus: a preliminary analysis of the phase II intergroup trial 0122. J Clin Oncol. 1996 Jan;14(1):149-55. doi: 10.1200/JCO.1996.14.1.149.
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Other Identifiers
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YP2010138
Identifier Type: -
Identifier Source: org_study_id