<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02969473</url>
  </required_header>
  <id_info>
    <org_study_id>YP2010138</org_study_id>
    <nct_id>NCT02969473</nct_id>
  </id_info>
  <brief_title>Definitive Concurrent Chemoradiotherapy With Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin in Patients With Esophageal Squamous Cell Carcinoma</brief_title>
  <official_title>Definitive Concurrent Chemoradiotherapy With Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin in Patients With Esophageal Squamous Cell Carcinoma: a Phase II Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhu Yujia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this phase II study, the investigators aim to evaluated the efficacy and toxicity of&#xD;
      definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen)&#xD;
      versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell&#xD;
      carcinoma (ESCC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Esophageal cancer is one of the most fatal malignancies worldwide. Radical surgery has been&#xD;
      the primary treatment for patients with resectable esophageal cancer. For medically unfit&#xD;
      patients or medically fit patients who decline surgery, definitive radiotherapy plus&#xD;
      concurrent chemotherapy has been established as a standard treatment. Since the 1980' s, the&#xD;
      most widely used chemotherapeutic regimen in combination with radiotherapy for esophageal&#xD;
      cancer was cisplatin (CDDP) plus 5-fluorouracil (5-FU) (the PF regimen). However,&#xD;
      locoregionally persistent or recurrent diseases were still quite common and survival remained&#xD;
      poor. Several previous studies conducted by the radiation therapy oncology group (RTOG)&#xD;
      explored the efficacy of radiation dose escalation, but all results turned out disappointing.&#xD;
      And studies incorporating intensified PF regimen or new-generation cytotoxic agents such as&#xD;
      paclitaxel and oxaliplatin did not show any advantage over the standard-dosage PF regimen&#xD;
      either. In this phase II study, the investigators aim to evaluated the efficacy and toxicity&#xD;
      of definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen)&#xD;
      versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell&#xD;
      carcinoma (ESCC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2010</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>From the date of randomization until the date of death, up to 5 years.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment response rate</measure>
    <time_frame>From the date of randomization until six weeks after treatment completion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progress Free Survival (PFS)</measure>
    <time_frame>From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute treatment-related toxicities</measure>
    <time_frame>From the date of randomization until six months after treatment completion.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Esophageal Neoplasm</condition>
  <condition>Chemoradiation</condition>
  <arm_group>
    <arm_group_label>PF group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This is the active comparator group. All patients in this group will receive concurrent chemoradiotherapy with PF regimen (5-fluorouracil plus cisplatin).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is the experimental group. All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>DP group</arm_group_label>
    <other_name>cisplatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluorouracil</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>PF group</arm_group_label>
    <other_name>cisplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with histologically proven squamous cell carcinoma of the esophagus&#xD;
&#xD;
          -  stage II-IVA disease, including metastatic celiac or cervical nodes, according to the&#xD;
             sixth edition of American Joint Committee on Cancer (AJCC) staging system for&#xD;
             esophageal cancer&#xD;
&#xD;
          -  aged between 18 and 70 years&#xD;
&#xD;
          -  Karnofsky Performance Status (KPS) score ≥ 70&#xD;
&#xD;
          -  adequate bone marrow function (leukocyte count ≥ 4000/uL, platelet count ≥&#xD;
             100,000/uL), adequate liver function (serum alanine aminotransferase (ALT) level and&#xD;
             serum aspartate aminotransferase (AST) level &lt; twice the upper limit of normal, and&#xD;
             serum bilirubin level of &lt;1.5 mg/dL), and adequate renal function (creatinine&#xD;
             clearance ≥ 50 mL/min)&#xD;
&#xD;
          -  no other serious medical conditions&#xD;
&#xD;
          -  life expectancy ≥ 3 months&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  detection of distant metastasis (excluding metastatic celiac or cervical nodes) before&#xD;
             treatment before treatment&#xD;
&#xD;
          -  known allergy to CDDP, 5-FU, or docetaxel&#xD;
&#xD;
          -  pregnancy or breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yonghong Hu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SYSU Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Ruppert BN, Watkins JM, Shirai K, Wahlquist AE, Garrett-Mayer E, Aguero EG, Sherman CA, Reed CE, Sharma AK. Cisplatin/Irinotecan versus carboplatin/paclitaxel as definitive chemoradiotherapy for locoregionally advanced esophageal cancer. Am J Clin Oncol. 2010 Aug;33(4):346-52. doi: 10.1097/COC.0b013e3181aaca26.</citation>
    <PMID>19841574</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11870157</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10235156</PMID>
  </reference>
  <reference>
    <citation>Herskovic A, Martz K, al-Sarraf M, Leichman L, Brindle J, Vaitkevicius V, Cooper J, Byhardt R, Davis L, Emami B. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med. 1992 Jun 11;326(24):1593-8. doi: 10.1056/NEJM199206113262403.</citation>
    <PMID>1584260</PMID>
  </reference>
  <reference>
    <citation>al-Sarraf M, Martz K, Herskovic A, Leichman L, Brindle JS, Vaitkevicius VK, Cooper J, Byhardt R, Davis L, Emami B. Progress report of combined chemoradiotherapy versus radiotherapy alone in patients with esophageal cancer: an intergroup study. J Clin Oncol. 1997 Jan;15(1):277-84. doi: 10.1200/JCO.1997.15.1.277. Erratum In: J Clin Oncol 1997 Feb;15(2):866.</citation>
    <PMID>8996153</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10699886</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8558190</PMID>
  </reference>
  <reference>
    <citation>Ajani JA, Winter K, Komaki R, Kelsen DP, Minsky BD, Liao Z, Bradley J, Fromm M, Hornback D, Willett CG. Phase II randomized trial of two nonoperative regimens of induction chemotherapy followed by chemoradiation in patients with localized carcinoma of the esophagus: RTOG 0113. J Clin Oncol. 2008 Oct 1;26(28):4551-6. doi: 10.1200/JCO.2008.16.6918. Epub 2008 Jun 23.</citation>
    <PMID>18574157</PMID>
  </reference>
  <reference>
    <citation>Mason KA, Hunter NR, Milas M, Abbruzzese JL, Milas L. Docetaxel enhances tumor radioresponse in vivo. Clin Cancer Res. 1997 Dec;3(12 Pt 1):2431-8.</citation>
    <PMID>9815644</PMID>
  </reference>
  <reference>
    <citation>Hennequin C, Giocanti N, Favaudon V. Interaction of ionizing radiation with paclitaxel (Taxol) and docetaxel (Taxotere) in HeLa and SQ20B cells. Cancer Res. 1996 Apr 15;56(8):1842-50.</citation>
    <PMID>8620502</PMID>
  </reference>
  <reference>
    <citation>Li QQ, Liu MZ, Hu YH, Liu H, He ZY, Lin HX. Definitive concomitant chemoradiotherapy with docetaxel and cisplatin in squamous esophageal carcinoma. Dis Esophagus. 2010 Apr;23(3):253-9. doi: 10.1111/j.1442-2050.2009.01003.x. Epub 2009 Aug 28.</citation>
    <PMID>19732130</PMID>
  </reference>
  <reference>
    <citation>Einzig AI, Neuberg D, Remick SC, Karp DD, O'Dwyer PJ, Stewart JA, Benson AB 3rd. Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: the Eastern Cooperative Oncology Group (ECOG) results of protocol E1293. Med Oncol. 1996 Jun;13(2):87-93. doi: 10.1007/BF02993858.</citation>
    <PMID>9013471</PMID>
  </reference>
  <reference>
    <citation>Ohtsu A, Boku N, Muro K, Chin K, Muto M, Yoshida S, Satake M, Ishikura S, Ogino T, Miyata Y, Seki S, Kaneko K, Nakamura A. Definitive chemoradiotherapy for T4 and/or M1 lymph node squamous cell carcinoma of the esophagus. J Clin Oncol. 1999 Sep;17(9):2915-21. doi: 10.1200/JCO.1999.17.9.2915.</citation>
    <PMID>10561371</PMID>
  </reference>
  <reference>
    <citation>Minsky BD, Neuberg D, Kelsen DP, Pisansky TM, Ginsberg RJ, Pajak T, Salter M, Benson AB 3rd. Final report of Intergroup Trial 0122 (ECOG PE-289, RTOG 90-12): Phase II trial of neoadjuvant chemotherapy plus concurrent chemotherapy and high-dose radiation for squamous cell carcinoma of the esophagus. Int J Radiat Oncol Biol Phys. 1999 Feb 1;43(3):517-23. doi: 10.1016/s0360-3016(98)00463-5.</citation>
    <PMID>10078631</PMID>
  </reference>
  <reference>
    <citation>Chandra A, Guerrero TM, Liu HH, Tucker SL, Liao Z, Wang X, Murshed H, Bonnen MD, Garg AK, Stevens CW, Chang JY, Jeter MD, Mohan R, Cox JD, Komaki R. Feasibility of using intensity-modulated radiotherapy to improve lung sparing in treatment planning for distal esophageal cancer. Radiother Oncol. 2005 Dec;77(3):247-53. doi: 10.1016/j.radonc.2005.10.017. Epub 2005 Nov 17.</citation>
    <PMID>16298001</PMID>
  </reference>
  <reference>
    <citation>Wu VW, Kwong DL, Sham JS. Target dose conformity in 3-dimensional conformal radiotherapy and intensity modulated radiotherapy. Radiother Oncol. 2004 May;71(2):201-6. doi: 10.1016/j.radonc.2004.03.004.</citation>
    <PMID>15110454</PMID>
  </reference>
  <reference>
    <citation>Wu Q, Manning M, Schmidt-Ullrich R, Mohan R. The potential for sparing of parotids and escalation of biologically effective dose with intensity-modulated radiation treatments of head and neck cancers: a treatment design study. Int J Radiat Oncol Biol Phys. 2000 Jan 1;46(1):195-205. doi: 10.1016/s0360-3016(99)00304-1.</citation>
    <PMID>10656393</PMID>
  </reference>
  <reference>
    <citation>Katsumata N, Yasuda M, Takahashi F, Isonishi S, Jobo T, Aoki D, Tsuda H, Sugiyama T, Kodama S, Kimura E, Ochiai K, Noda K; Japanese Gynecologic Oncology Group. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1331-8. doi: 10.1016/S0140-6736(09)61157-0. Epub 2009 Sep 18.</citation>
    <PMID>19767092</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 16, 2016</last_update_submitted>
  <last_update_submitted_qc>November 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Zhu Yujia</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>esophageal squamous cell carcinoma</keyword>
  <keyword>concurrent chemoradiotherapy</keyword>
  <keyword>docetaxel</keyword>
  <keyword>cisplatin</keyword>
  <keyword>5-fluorouracil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02969473
org study id: YP2010138
nct id: NCT02969473
lead sponsor: 
has dmc: Yes
In this phase II study, the investigators aim to evaluated the efficacy and toxicity of
      definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen)
      versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell
      carcinoma (ESCC).
Esophageal cancer is one of the most fatal malignancies worldwide. Radical surgery has been
      the primary treatment for patients with resectable esophageal cancer. For medically unfit
      patients or medically fit patients who decline surgery, definitive radiotherapy plus
      concurrent chemotherapy has been established as a standard treatment. Since the 1980' s, the
      most widely used chemotherapeutic regimen in combination with radiotherapy for esophageal
      cancer was cisplatin (CDDP) plus 5-fluorouracil (5-FU) (the PF regimen). However,
      locoregionally persistent or recurrent diseases were still quite common and survival remained
      poor. Several previous studies conducted by the radiation therapy oncology group (RTOG)
      explored the efficacy of radiation dose escalation, but all results turned out disappointing.
      And studies incorporating intensified PF regimen or new-generation cytotoxic agents such as
      paclitaxel and oxaliplatin did not show any advantage over the standard-dosage PF regimen
      either. In this phase II study, the investigators aim to evaluated the efficacy and toxicity
      of definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen)
      versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell
      carcinoma (ESCC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival (OS)
time frame: From the date of randomization until the date of death, up to 5 years.
measure: Treatment response rate
time frame: From the date of randomization until six weeks after treatment completion.
measure: Progress Free Survival (PFS)
time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
measure: Acute treatment-related toxicities
time frame: From the date of randomization until six months after treatment completion.
arm group label: PF group
arm group type: Active Comparator
description: This is the active comparator group. All patients in this group will receive concurrent chemoradiotherapy with PF regimen (5-fluorouracil plus cisplatin).
arm group label: DP group
arm group type: Experimental
description: This is the experimental group. All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).
intervention type: Drug
intervention name: Docetaxel
description: 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.
arm group label: DP group
other name: cisplatin
intervention type: Drug
intervention name: Fluorouracil
description: 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.
arm group label: PF group
other name: cisplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yonghong Hu, MD
role: Principal Investigator
affiliation: Sun Yat-sen University
facility: 
country: China
citation: Ruppert BN, Watkins JM, Shirai K, Wahlquist AE, Garrett-Mayer E, Aguero EG, Sherman CA, Reed CE, Sharma AK. Cisplatin/Irinotecan versus carboplatin/paclitaxel as definitive chemoradiotherapy for locoregionally advanced esophageal cancer. Am J Clin Oncol. 2010 Aug;33(4):346-52. doi: 10.1097/COC.0b013e3181aaca26.
PMID: 19841574
citation: 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.
PMID: 11870157
citation: 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.
PMID: 10235156
citation: Herskovic A, Martz K, al-Sarraf M, Leichman L, Brindle J, Vaitkevicius V, Cooper J, Byhardt R, Davis L, Emami B. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med. 1992 Jun 11;326(24):1593-8. doi: 10.1056/NEJM199206113262403.
PMID: 1584260
citation: al-Sarraf M, Martz K, Herskovic A, Leichman L, Brindle JS, Vaitkevicius VK, Cooper J, Byhardt R, Davis L, Emami B. Progress report of combined chemoradiotherapy versus radiotherapy alone in patients with esophageal cancer: an intergroup study. J Clin Oncol. 1997 Jan;15(1):277-84. doi: 10.1200/JCO.1997.15.1.277. Erratum In: J Clin Oncol 1997 Feb;15(2):866.
PMID: 8996153
citation: 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.
PMID: 10699886
citation: 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.
PMID: 8558190
citation: Ajani JA, Winter K, Komaki R, Kelsen DP, Minsky BD, Liao Z, Bradley J, Fromm M, Hornback D, Willett CG. Phase II randomized trial of two nonoperative regimens of induction chemotherapy followed by chemoradiation in patients with localized carcinoma of the esophagus: RTOG 0113. J Clin Oncol. 2008 Oct 1;26(28):4551-6. doi: 10.1200/JCO.2008.16.6918. Epub 2008 Jun 23.
PMID: 18574157
citation: Mason KA, Hunter NR, Milas M, Abbruzzese JL, Milas L. Docetaxel enhances tumor radioresponse in vivo. Clin Cancer Res. 1997 Dec;3(12 Pt 1):2431-8.
PMID: 9815644
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responsible party type: Sponsor-Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Zhu Yujia
investigator title: MD
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Esophageal Squamous Cell Carcinoma
mesh term: Esophageal Neoplasms
mesh term: Cisplatin
mesh term: Docetaxel
mesh term: Fluorouracil