<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/NCT01721785</url>
  </required_header>
  <id_info>
    <org_study_id>12-2-051</org_study_id>
    <secondary_id>2012-002935-27</secondary_id>
    <nct_id>NCT01721785</nct_id>
  </id_info>
  <brief_title>Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer</brief_title>
  <official_title>Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dutch Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the clinical value of the novel MRI-techniques DWI&#xD;
      and gadofosveset-enhanced MRI for the management of rectal cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rectal cancer is a common form of cancer, and the treatment stratification depends on tumour&#xD;
      and nodal stage as determined on MRI. Unfortunately, the information provided by standard&#xD;
      T2-weighted MRI is not sufficient to accurately assess nodal involvement and tumour response&#xD;
      after neo-adjuvant chemoradiotherapy. Additional functional information is required for&#xD;
      reliable (re)staging. Diffusion-weighted imaging and gadofosveset-enhanced MRI are two new&#xD;
      imaging techniques that have all shown great potential in rectal cancer staging. In order to&#xD;
      provide definite evidence there is a need for a multicenter study with a large patient&#xD;
      population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic performance of the techniques under investigation</measure>
    <time_frame>2 years</time_frame>
    <description>Techniques under investigation are diffusion-weighted imaging for tumour response assessment and gadofosveset-enhanced MRI for nodal assessment, compared to standard T2-weighted MRI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine the inter-observer agreement for the imaging techniques under investigation</measure>
    <time_frame>2 years</time_frame>
    <description>Detection of the differences between expert vs non-expert readers and general vs referral centres concerning diffusion-weighted imaging and gadofosveset-enhanced MRI.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">307</enrollment>
  <condition>Rectal Neoplasms</condition>
  <condition>Magnetic Resonance Imaging</condition>
  <condition>Neoplasms Staging</condition>
  <arm_group>
    <arm_group_label>Primary staging group I</arm_group_label>
    <description>All patients will be treated according to standard practice of the concerning hospital.&#xD;
Patients in group I are patients that will be stratified for direct surgery (TME) or a short-course of radiotherapy (5x5 Gy) followed by immediate TME.&#xD;
Group I will undergo only a staging MRI, including gadofosveset-enhanced MRI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Restaging group II</arm_group_label>
    <description>All patients will be treated according to standard practice of the concerning hospital.&#xD;
Patients in group II are patients that will be stratified for a long course of chemoradiotherapy.&#xD;
Group II will undergo a staging MRI, a re-staging MRI and a optional sigmoidoscopy as part of restaging. MRI includes diffusion-weighted imaging and gadofosveset-enhanced MRI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]</intervention_name>
    <description>Gadofosveset will be used as a lymph-node specific MRI contrast agent and will be administered by manual injection as a single intravenous bolus during MRI.</description>
    <arm_group_label>Primary staging group I</arm_group_label>
    <arm_group_label>Restaging group II</arm_group_label>
    <other_name>Ablavar</other_name>
    <other_name>MS-325</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients diagnosed with rectal cancer in one of the participating centres will be&#xD;
        considered for inclusion in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biopsy proven primary rectal cancer (≤15 cm from the anorectal verge as measured in&#xD;
             MRI)&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ineligibility to undergo MRI (claustrophobia, pacemaker, non-MR compatible surgical&#xD;
             implants, metal fragments in the eye)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Locally recurrent rectal cancer&#xD;
&#xD;
          -  A history of severe allergy to contrast agents&#xD;
&#xD;
          -  Ineligibility to receive gadofosveset contrast (history of contrast allergy, impaired&#xD;
             kidney function with a Glomerular Filtration Rate &lt;30 ml/min/1.73m2&#xD;
&#xD;
          -  Incurable disease due to metastases or co-morbidity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Regina Beets-Tan, Prof. MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radiology, MUMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Geerard Beets, Ass Prof. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Surgery, MUMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Doenja Lambregts, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Radiology, MUMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Monique Maas, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Radiology, MUMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Atrium Medisch Centrum</name>
      <address>
        <city>Heerlen</city>
        <state>Limburg</state>
        <zip>6401 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6202 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orbis Medisch Centrum</name>
      <address>
        <city>Sittard-Geleen</city>
        <state>Limburg</state>
        <zip>6130 MB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viecuri Medisch Centrum</name>
      <address>
        <city>Venlo</city>
        <state>Limburg</state>
        <zip>5912 BL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeroen Bosch Ziekenhuis</name>
      <address>
        <city>'s Hertogenbosch</city>
        <state>Noord-Brabant</state>
        <zip>5223 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amphia Ziekenhuis</name>
      <address>
        <city>Breda</city>
        <state>Noord-Brabant</state>
        <zip>4800 RL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catharina Ziekenhuis</name>
      <address>
        <city>Eindhoven</city>
        <state>Noord-Brabant</state>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maxima Medisch Centrum</name>
      <address>
        <city>Veldhoven</city>
        <state>Noord-Brabant</state>
        <zip>5500 MB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMC</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1100 DD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZGT</name>
      <address>
        <city>Almelo</city>
        <state>Overrijsel</state>
        <zip>7600 SZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Lahaye MJ, Engelen SM, Nelemans PJ, Beets GL, van de Velde CJ, van Engelshoven JM, Beets-Tan RG. Imaging for predicting the risk factors--the circumferential resection margin and nodal disease--of local recurrence in rectal cancer: a meta-analysis. Semin Ultrasound CT MR. 2005 Aug;26(4):259-68. doi: 10.1053/j.sult.2005.04.005.</citation>
    <PMID>16152740</PMID>
  </reference>
  <reference>
    <citation>Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewe KW, Buijsen J, Beets GL. Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol. 2011 Dec 10;29(35):4633-40. doi: 10.1200/JCO.2011.37.7176. Epub 2011 Nov 7.</citation>
    <PMID>22067400</PMID>
  </reference>
  <reference>
    <citation>Maas M, Nelemans PJ, Valentini V, Das P, Rodel C, Kuo LJ, Calvo FA, Garcia-Aguilar J, Glynne-Jones R, Haustermans K, Mohiuddin M, Pucciarelli S, Small W Jr, Suarez J, Theodoropoulos G, Biondo S, Beets-Tan RG, Beets GL. Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data. Lancet Oncol. 2010 Sep;11(9):835-44. doi: 10.1016/S1470-2045(10)70172-8. Epub 2010 Aug 6.</citation>
    <PMID>20692872</PMID>
  </reference>
  <reference>
    <citation>Habr-Gama A, Perez RO, Proscurshim I, Campos FG, Nadalin W, Kiss D, Gama-Rodrigues J. Patterns of failure and survival for nonoperative treatment of stage c0 distal rectal cancer following neoadjuvant chemoradiation therapy. J Gastrointest Surg. 2006 Dec;10(10):1319-28; discussion 1328-9. doi: 10.1016/j.gassur.2006.09.005.</citation>
    <PMID>17175450</PMID>
  </reference>
  <reference>
    <citation>Lambregts DM, Beets GL, Maas M, Kessels AG, Bakers FC, Cappendijk VC, Engelen SM, Lahaye MJ, de Bruine AP, Lammering G, Leiner T, Verwoerd JL, Wildberger JE, Beets-Tan RG. Accuracy of gadofosveset-enhanced MRI for nodal staging and restaging in rectal cancer. Ann Surg. 2011 Mar;253(3):539-45. doi: 10.1097/SLA.0b013e31820b01f1.</citation>
    <PMID>21239980</PMID>
  </reference>
  <reference>
    <citation>Herborn CU, Lauenstein TC, Vogt FM, Lauffer RB, Debatin JF, Ruehm SG. Interstitial MR lymphography with MS-325: characterization of normal and tumor-invaded lymph nodes in a rabbit model. AJR Am J Roentgenol. 2002 Dec;179(6):1567-72. doi: 10.2214/ajr.179.6.1791567.</citation>
    <PMID>12438057</PMID>
  </reference>
  <reference>
    <citation>Yamashita T, Takahara T, Kwee TC, Kawada S, Horie T, Inomoto C, Hashida K, Yamamuro H, Myojin K, Luijten PR, Imai Y. Diffusion magnetic resonance imaging with gadofosveset trisodium as a negative contrast agent for lymph node metastases assessment. Jpn J Radiol. 2011 Jan;29(1):25-32. doi: 10.1007/s11604-010-0513-2. Epub 2011 Jan 26.</citation>
    <PMID>21264658</PMID>
  </reference>
  <reference>
    <citation>Kim SH, Lee JY, Lee JM, Han JK, Choi BI. Apparent diffusion coefficient for evaluating tumour response to neoadjuvant chemoradiation therapy for locally advanced rectal cancer. Eur Radiol. 2011 May;21(5):987-95. doi: 10.1007/s00330-010-1989-y. Epub 2010 Oct 27.</citation>
    <PMID>20978768</PMID>
  </reference>
  <reference>
    <citation>Kim SH, Lee JM, Hong SH, Kim GH, Lee JY, Han JK, Choi BI. Locally advanced rectal cancer: added value of diffusion-weighted MR imaging in the evaluation of tumor response to neoadjuvant chemo- and radiation therapy. Radiology. 2009 Oct;253(1):116-25. doi: 10.1148/radiol.2532090027.</citation>
    <PMID>19789256</PMID>
  </reference>
  <reference>
    <citation>Lambregts DM, Vandecaveye V, Barbaro B, Bakers FC, Lambrecht M, Maas M, Haustermans K, Valentini V, Beets GL, Beets-Tan RG. Diffusion-weighted MRI for selection of complete responders after chemoradiation for locally advanced rectal cancer: a multicenter study. Ann Surg Oncol. 2011 Aug;18(8):2224-31. doi: 10.1245/s10434-011-1607-5. Epub 2011 Feb 23.</citation>
    <PMID>21347783</PMID>
  </reference>
  <reference>
    <citation>Curvo-Semedo L, Lambregts DM, Maas M, Thywissen T, Mehsen RT, Lammering G, Beets GL, Caseiro-Alves F, Beets-Tan RG. Rectal cancer: assessment of complete response to preoperative combined radiation therapy with chemotherapy--conventional MR volumetry versus diffusion-weighted MR imaging. Radiology. 2011 Sep;260(3):734-43. doi: 10.1148/radiol.11102467. Epub 2011 Jun 14.</citation>
    <PMID>21673229</PMID>
  </reference>
  <reference>
    <citation>Habr-Gama A, Perez RO, Wynn G, Marks J, Kessler H, Gama-Rodrigues J. Complete clinical response after neoadjuvant chemoradiation therapy for distal rectal cancer: characterization of clinical and endoscopic findings for standardization. Dis Colon Rectum. 2010 Dec;53(12):1692-8. doi: 10.1007/DCR.0b013e3181f42b89.</citation>
    <PMID>21178866</PMID>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>March 21, 2017</last_update_submitted>
  <last_update_submitted_qc>March 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nodal imaging</keyword>
  <keyword>Restaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01721785
org study id: 12-2-051
secondary id: 2012-002935-27
nct id: NCT01721785
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the clinical value of the novel MRI-techniques DWI
      and gadofosveset-enhanced MRI for the management of rectal cancer patients.
Rectal cancer is a common form of cancer, and the treatment stratification depends on tumour
      and nodal stage as determined on MRI. Unfortunately, the information provided by standard
      T2-weighted MRI is not sufficient to accurately assess nodal involvement and tumour response
      after neo-adjuvant chemoradiotherapy. Additional functional information is required for
      reliable (re)staging. Diffusion-weighted imaging and gadofosveset-enhanced MRI are two new
      imaging techniques that have all shown great potential in rectal cancer staging. In order to
      provide definite evidence there is a need for a multicenter study with a large patient
      population.
observational model: Cohort
time perspective: Prospective
measure: Diagnostic performance of the techniques under investigation
time frame: 2 years
description: Techniques under investigation are diffusion-weighted imaging for tumour response assessment and gadofosveset-enhanced MRI for nodal assessment, compared to standard T2-weighted MRI.
measure: To determine the inter-observer agreement for the imaging techniques under investigation
time frame: 2 years
description: Detection of the differences between expert vs non-expert readers and general vs referral centres concerning diffusion-weighted imaging and gadofosveset-enhanced MRI.
arm group label: Primary staging group I
description: All patients will be treated according to standard practice of the concerning hospital.
Patients in group I are patients that will be stratified for direct surgery (TME) or a short-course of radiotherapy (5x5 Gy) followed by immediate TME.
Group I will undergo only a staging MRI, including gadofosveset-enhanced MRI.
arm group label: Restaging group II
description: All patients will be treated according to standard practice of the concerning hospital.
Patients in group II are patients that will be stratified for a long course of chemoradiotherapy.
Group II will undergo a staging MRI, a re-staging MRI and a optional sigmoidoscopy as part of restaging. MRI includes diffusion-weighted imaging and gadofosveset-enhanced MRI.
intervention type: Drug
intervention name: GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]
description: Gadofosveset will be used as a lymph-node specific MRI contrast agent and will be administered by manual injection as a single intravenous bolus during MRI.
arm group label: Primary staging group I
arm group label: Restaging group II
other name: Ablavar
other name: MS-325
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Regina Beets-Tan, Prof. MD.
role: Principal Investigator
affiliation: Radiology, MUMC
last name: Geerard Beets, Ass Prof. MD
role: Principal Investigator
affiliation: Surgery, MUMC
last name: Doenja Lambregts, MD
role: Study Chair
affiliation: Radiology, MUMC
last name: Monique Maas, MD
role: Study Chair
affiliation: Radiology, MUMC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
citation: Lahaye MJ, Engelen SM, Nelemans PJ, Beets GL, van de Velde CJ, van Engelshoven JM, Beets-Tan RG. Imaging for predicting the risk factors--the circumferential resection margin and nodal disease--of local recurrence in rectal cancer: a meta-analysis. Semin Ultrasound CT MR. 2005 Aug;26(4):259-68. doi: 10.1053/j.sult.2005.04.005.
PMID: 16152740
citation: Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewe KW, Buijsen J, Beets GL. Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol. 2011 Dec 10;29(35):4633-40. doi: 10.1200/JCO.2011.37.7176. Epub 2011 Nov 7.
PMID: 22067400
citation: Maas M, Nelemans PJ, Valentini V, Das P, Rodel C, Kuo LJ, Calvo FA, Garcia-Aguilar J, Glynne-Jones R, Haustermans K, Mohiuddin M, Pucciarelli S, Small W Jr, Suarez J, Theodoropoulos G, Biondo S, Beets-Tan RG, Beets GL. Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data. Lancet Oncol. 2010 Sep;11(9):835-44. doi: 10.1016/S1470-2045(10)70172-8. Epub 2010 Aug 6.
PMID: 20692872
citation: Habr-Gama A, Perez RO, Proscurshim I, Campos FG, Nadalin W, Kiss D, Gama-Rodrigues J. Patterns of failure and survival for nonoperative treatment of stage c0 distal rectal cancer following neoadjuvant chemoradiation therapy. J Gastrointest Surg. 2006 Dec;10(10):1319-28; discussion 1328-9. doi: 10.1016/j.gassur.2006.09.005.
PMID: 17175450
citation: Lambregts DM, Beets GL, Maas M, Kessels AG, Bakers FC, Cappendijk VC, Engelen SM, Lahaye MJ, de Bruine AP, Lammering G, Leiner T, Verwoerd JL, Wildberger JE, Beets-Tan RG. Accuracy of gadofosveset-enhanced MRI for nodal staging and restaging in rectal cancer. Ann Surg. 2011 Mar;253(3):539-45. doi: 10.1097/SLA.0b013e31820b01f1.
PMID: 21239980
citation: Herborn CU, Lauenstein TC, Vogt FM, Lauffer RB, Debatin JF, Ruehm SG. Interstitial MR lymphography with MS-325: characterization of normal and tumor-invaded lymph nodes in a rabbit model. AJR Am J Roentgenol. 2002 Dec;179(6):1567-72. doi: 10.2214/ajr.179.6.1791567.
PMID: 12438057
citation: Yamashita T, Takahara T, Kwee TC, Kawada S, Horie T, Inomoto C, Hashida K, Yamamuro H, Myojin K, Luijten PR, Imai Y. Diffusion magnetic resonance imaging with gadofosveset trisodium as a negative contrast agent for lymph node metastases assessment. Jpn J Radiol. 2011 Jan;29(1):25-32. doi: 10.1007/s11604-010-0513-2. Epub 2011 Jan 26.
PMID: 21264658
citation: Kim SH, Lee JY, Lee JM, Han JK, Choi BI. Apparent diffusion coefficient for evaluating tumour response to neoadjuvant chemoradiation therapy for locally advanced rectal cancer. Eur Radiol. 2011 May;21(5):987-95. doi: 10.1007/s00330-010-1989-y. Epub 2010 Oct 27.
PMID: 20978768
citation: Kim SH, Lee JM, Hong SH, Kim GH, Lee JY, Han JK, Choi BI. Locally advanced rectal cancer: added value of diffusion-weighted MR imaging in the evaluation of tumor response to neoadjuvant chemo- and radiation therapy. Radiology. 2009 Oct;253(1):116-25. doi: 10.1148/radiol.2532090027.
PMID: 19789256
citation: Lambregts DM, Vandecaveye V, Barbaro B, Bakers FC, Lambrecht M, Maas M, Haustermans K, Valentini V, Beets GL, Beets-Tan RG. Diffusion-weighted MRI for selection of complete responders after chemoradiation for locally advanced rectal cancer: a multicenter study. Ann Surg Oncol. 2011 Aug;18(8):2224-31. doi: 10.1245/s10434-011-1607-5. Epub 2011 Feb 23.
PMID: 21347783
citation: Curvo-Semedo L, Lambregts DM, Maas M, Thywissen T, Mehsen RT, Lammering G, Beets GL, Caseiro-Alves F, Beets-Tan RG. Rectal cancer: assessment of complete response to preoperative combined radiation therapy with chemotherapy--conventional MR volumetry versus diffusion-weighted MR imaging. Radiology. 2011 Sep;260(3):734-43. doi: 10.1148/radiol.11102467. Epub 2011 Jun 14.
PMID: 21673229
citation: Habr-Gama A, Perez RO, Wynn G, Marks J, Kessler H, Gama-Rodrigues J. Complete clinical response after neoadjuvant chemoradiation therapy for distal rectal cancer: characterization of clinical and endoscopic findings for standardization. Dis Colon Rectum. 2010 Dec;53(12):1692-8. doi: 10.1007/DCR.0b013e3181f42b89.
PMID: 21178866
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Rectal Neoplasms
sharing ipd: Undecided