<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/NCT03005743</url>
  </required_header>
  <id_info>
    <org_study_id>TMH-1587</org_study_id>
    <nct_id>NCT03005743</nct_id>
  </id_info>
  <brief_title>Image Based Brachytherapy in Locally Advanced Cervical Cancers - a Randomized Controlled Trial</brief_title>
  <acronym>COMBAT-Cx</acronym>
  <official_title>COnventional Radiography Based Intracavitary Brachytherapy (Standard Arm) Versus Magnetic Resonance Image Based BrAchyTherapy (Study Arm) in Locally Advanced Cervical Cancers: A Phase III Randomized Controlled Trial (COMBAT - Cervix Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tata Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tata Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of the study is to determine whether Image based brachytherapy is superior in terms&#xD;
      of local control to Conventional radiograph based brachytherapy in locally advanced cervical&#xD;
      cancers in a Phase III randomized setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The standard treatment of locally advanced cervical cancer is radio-chemotherapy including&#xD;
      external beam radiotherapy (EBRT), brachytherapy (BT) and concomitant chemotherapy with&#xD;
      weekly Cisplatin. While image based conformal EBRT is routinely used, prescription and&#xD;
      reporting of BT is still based on specific dose points which are conventional radiography&#xD;
      based surrogates for tumour (Manchester point A prescription point) and normal tissues&#xD;
      [International commission on Radiation Units and Measurements (ICRU) Bladder and Rectum&#xD;
      point]. This conventional radiography based planning has been adopted universally for ease of&#xD;
      delivering safe doses with reasonably good local control rates (stage IIB - 85%; Stage IIIB -&#xD;
      65%) and acceptable acute and late toxicities (&lt;/=10% grade III/IV). Thus, for several&#xD;
      decades conventional radiography based prescription has been standard of care universally.&#xD;
      But these conventional radiography based surrogates have been proved to be only rough&#xD;
      estimates and do not always correlate in 3 dimensional (3D) anatomy for neither tumour nor&#xD;
      normal tissues for actual doses delivered and outcomes in terms of control rates and&#xD;
      toxicities respectively. Several studies have been published demonstrating limitations and&#xD;
      criticizing this point based treatments. In 2006, a working group from Groupe Européen de&#xD;
      Curiethérapie- European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) has&#xD;
      published recommendations on contouring of tumour target and organs at risk (OAR) as well as&#xD;
      on dose volume parameters to be reported for image guided BT in definitive radiotherapy for&#xD;
      locally advanced cervical cancer. These recommendations are mainly derived from retrospective&#xD;
      single institution experience with Magnetic Resonance (MR) image based Intracavitary&#xD;
      Brachytherapy (ICBT). The major advantage of this technique is the possibility to conform the&#xD;
      dose given by BT with regard to volume (3D) for both tumour and critical normal tissues&#xD;
      (bladder, rectum, sigmoid mainly). Thus, by repetitive imaging performed before each BT&#xD;
      treatment it is possible to adapt dose given as per the anatomy of each individual patient&#xD;
      taking into account not only the position of OAR but also the tumour regression which often&#xD;
      is obtained by preceding EBRT and chemotherapy. Clinical Outcome data from Vienna, Paris and&#xD;
      Mumbai have shown potential in improved local control rates with acceptable toxicities so&#xD;
      far. Prospectively treated more than 100 patients with image based brachytherapy from Vienna&#xD;
      Group have shown improved local control rates across all stages with decreased toxicity on&#xD;
      comparisons with historical series of patients treated with Conventional Radiography based BT&#xD;
      [13-19]. Also, a phase II multicentre intercontinental study using MR Image Based&#xD;
      Brachytherapy (EMBRACE: European study on MRI-guided Brachytherapy in Locally Advanced&#xD;
      Cervical Cancer) has been implemented and tested in various centres across the world&#xD;
      including Tata Memorial Hospital, Mumbai. Over 600 patients have been recruited in the study&#xD;
      so far. Based on the experience collected so far, the image based BT approach is expected to&#xD;
      have a major impact on the clinical outcome for II B and III B (increase in local control&#xD;
      rates by 10-20%) with concomitant decrease in the rates of late normal tissue toxicity (&lt;5%&#xD;
      Grade ¾), as compared to historical results for point based conventional treatment&#xD;
      prescriptions [20].&#xD;
&#xD;
      EMBRACE is a study on MRI guided brachytherapy (BT) in locally advanced cervical cancer.&#xD;
      Today point-based two-dimensional BT is most often used for definitive radiotherapy in&#xD;
      cervical cancer. However, MRI guided Image Based brachytherapy is increasingly being used in&#xD;
      several centres, and the results reported so far are very promising. The major advantage of&#xD;
      this technique is the possibility to conform the dose given by BT with regard to both volume&#xD;
      (3D) and time (4D). Thus, by repetitive imaging performed before each BT implant it is&#xD;
      possible to adapt the dose given by BT to the anatomy of each individual patient taking into&#xD;
      account not only the position of organs at risk but also the tumour regression which often is&#xD;
      obtained by preceding external beam radiotherapy and chemotherapy. Based on the experience&#xD;
      collected so far, the image based BT approach significantly improves the dose-volume&#xD;
      histogram (DVH) parameters and the improved dose delivered seems to have a major impact on&#xD;
      the clinical outcome with a concomitant decrease in the rates of both local failure and&#xD;
      morbidity. Preliminary results of ongoing studies including RETRO EMBRACE (600 patients -&#xD;
      retrospective multicentric analysis) and EMBRACE (1000 patients recruited so far&#xD;
      prospectively multicentric) also suggest excellent local control rates &amp; minimal clinical&#xD;
      significant toxicities.&#xD;
&#xD;
      Hypothesis: The clinical outcome of radical radiation therapy including Conventional&#xD;
      radiography based brachytherapy for International Federation of Gynecology and Obstetrics&#xD;
      (FIGO) Stage IIB and IIIB reported in historical series is 75% and 55% local control rates&#xD;
      and grade ¾ rectal / bladder toxicities of 10-15%. With the addition of concomitant cisplatin&#xD;
      chemotherapy there is an additional local control benefit of 5-10% and potentially increase&#xD;
      in late toxicities (no substantial evidence for toxicities reported so far). With the MR&#xD;
      Image Based Brachytherapy approach, mono-institutional series and phase II multicentric&#xD;
      international study, the results reported so far show an improvement in local control rates&#xD;
      to 96% and 86% for IIB and IIIB respectively and late toxicities &lt;5% reported so far. We&#xD;
      propose this randomized control study to test the following hypothesis: With the use of MR&#xD;
      Image Based Brachytherapy (Study Arm) in locally advanced cervical cancers (Stratified for&#xD;
      Stage IIB and IIIB), there will be an absolute increase in local control rates by 10% and&#xD;
      reduction in late rectal and bladder toxicities by 5% - 10% as compared to the Conventional&#xD;
      radiography based ICBT. Thus, for demonstrating absolute local control benefit of 10% in&#xD;
      Stages IIB (85% to 95%) and Stage IIIB (65% to 75%) a total of 1050 patients (350 patients&#xD;
      with Stage IIB and 650 patients with stage IIB respectively) will be accrued.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>N/A</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>Local control</measure>
    <time_frame>2 years</time_frame>
    <description>Absolute benefit in local control rates by 10% for stages FIGO IIB and IIIB</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Late toxicities</measure>
    <time_frame>2 years</time_frame>
    <description>Reduction in grade 3 and grade 4 (CTCAE) late toxicities from 10% to 5% (by 50%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pelvic control rates</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant failure rates</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free &amp; cause specific survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionnaire EORTC QLQ C30</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality life questionnaire EORTC QLQ CX24</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1050</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>MR based BT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Magnetic Resonance Image based Brachytherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional BT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Conventional Radiograph based Brachytherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Magnetic Resonance Image based Brachytherapy</intervention_name>
    <description>MRI based BT prescription will be in accordance to the GEC-ESTRO guidelines [Intention will be to treat the whole cervix and the remaining residual tumour tissue at the primary site at the time of BT (high risk-clinical target volume) to a dose level analogue to the dose level previously prescribed for point-A]</description>
    <arm_group_label>MR based BT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Conventional Radiograph based Brachytherapy</intervention_name>
    <description>The standard conventional radiography based prescription will be according to Manchester system Point A and bladder &amp; rectum ICRU point dose constraints</description>
    <arm_group_label>Conventional BT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cancer of the uterine cervix considered suitable for curative treatment with&#xD;
             definitive radio-(chemo) therapy including MRI guided Brachytherapy.&#xD;
&#xD;
          -  Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell&#xD;
             carcinoma of the uterine cervix.&#xD;
&#xD;
          -  Stage IIB/IIIB according to FIGO and tumor node metastasis (TNM) guidelines&#xD;
&#xD;
          -  Suitable for Brachytherapy boost&#xD;
&#xD;
          -  MRI of pelvis at diagnosis is performed&#xD;
&#xD;
          -  MRI, Computed Tomography (CT) or Positron Emission Tomography (PET) -CT of the&#xD;
             retroperitoneal space and abdomen at diagnosis is performed to rule out Para-aortic&#xD;
             lymph node metastasis.&#xD;
&#xD;
          -  Patient informed consent&#xD;
&#xD;
          -  Pre-treatment Haemoglobin level &gt;10 g/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other primary malignancies except carcinoma in situ of the cervix and basal cell&#xD;
             carcinoma of the skin.&#xD;
&#xD;
          -  Metastatic disease&#xD;
&#xD;
          -  Patients with para-aortic metastatic nodes (stage IVB) to the level of L2 vertebra or&#xD;
             further dissemination&#xD;
&#xD;
          -  Previous pelvic or abdominal radiotherapy&#xD;
&#xD;
          -  Previous total or partial hysterectomy&#xD;
&#xD;
          -  Combination of preoperative radiotherapy with surgery&#xD;
&#xD;
          -  Patients receiving BT only&#xD;
&#xD;
          -  Patients receiving EBRT only&#xD;
&#xD;
          -  Patients receiving neoadjuvant chemotherapy&#xD;
&#xD;
          -  Contraindications to MRI&#xD;
&#xD;
          -  Contraindications to BT&#xD;
&#xD;
          -  Active infection or severe medical condition endangering treatment delivery.&#xD;
&#xD;
          -  Pregnant, lactating or childbearing potential without adequate contraception&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Umesh Mahantshetty, MD, DNB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor, Department of Radiation Oncology, Tata memorial Hospital, Mumbai 400012</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Umesh Mahantshetty, MD, DNB</last_name>
    <phone>+91 2224177000</phone>
    <phone_ext>7168</phone_ext>
    <email>mahantshettyum@tmc.gov.in</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tata Memorial Hospital</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400012</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Umesh Mahantshetty, MD, DNB</last_name>
      <phone>+91 2224177000</phone>
      <phone_ext>7168</phone_ext>
      <email>mahantshettyum@tmc.gov.in</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Perez CA, Grigsby PW, Chao KS, Mutch DG, Lockett MA. Tumor size, irradiation dose, and long-term outcome of carcinoma of uterine cervix. Int J Radiat Oncol Biol Phys. 1998 May 1;41(2):307-17. doi: 10.1016/s0360-3016(98)00067-4. Erratum In: Int J Radiat Oncol Biol Phys 1999 Nov 1;45(4):1093.</citation>
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  <reference>
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  <reference>
    <citation>Prescribing, Recording, and Reporting Brachytherapy for Cancer of the Cervix. J ICRU. 2013 Apr;13(1-2):NP. doi: 10.1093/jicru/ndw027. No abstract available.</citation>
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  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>January 18, 2018</last_update_submitted>
  <last_update_submitted_qc>January 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tata Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Dr Umesh Mahantshetty</investigator_full_name>
    <investigator_title>Professor, Department of Radiation Oncology, Tata Memorial Hospital, Parel, Mumbai 400012</investigator_title>
  </responsible_party>
  <keyword>Cervical cancer</keyword>
  <keyword>Brachytherapy</keyword>
  <keyword>Conventional planning</keyword>
  <keyword>MR based Brachytherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_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/NCT03005743
org study id: TMH-1587
nct id: NCT03005743
lead sponsor: 
has dmc: Yes
Purpose of the study is to determine whether Image based brachytherapy is superior in terms
      of local control to Conventional radiograph based brachytherapy in locally advanced cervical
      cancers in a Phase III randomized setting.
The standard treatment of locally advanced cervical cancer is radio-chemotherapy including
      external beam radiotherapy (EBRT), brachytherapy (BT) and concomitant chemotherapy with
      weekly Cisplatin. While image based conformal EBRT is routinely used, prescription and
      reporting of BT is still based on specific dose points which are conventional radiography
      based surrogates for tumour (Manchester point A prescription point) and normal tissues
      [International commission on Radiation Units and Measurements (ICRU) Bladder and Rectum
      point]. This conventional radiography based planning has been adopted universally for ease of
      delivering safe doses with reasonably good local control rates (stage IIB - 85%; Stage IIIB -
      65%) and acceptable acute and late toxicities (</=10% grade III/IV). Thus, for several
      decades conventional radiography based prescription has been standard of care universally.
      But these conventional radiography based surrogates have been proved to be only rough
      estimates and do not always correlate in 3 dimensional (3D) anatomy for neither tumour nor
      normal tissues for actual doses delivered and outcomes in terms of control rates and
      toxicities respectively. Several studies have been published demonstrating limitations and
      criticizing this point based treatments. In 2006, a working group from Groupe Européen de
      Curiethérapie- European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) has
      published recommendations on contouring of tumour target and organs at risk (OAR) as well as
      on dose volume parameters to be reported for image guided BT in definitive radiotherapy for
      locally advanced cervical cancer. These recommendations are mainly derived from retrospective
      single institution experience with Magnetic Resonance (MR) image based Intracavitary
      Brachytherapy (ICBT). The major advantage of this technique is the possibility to conform the
      dose given by BT with regard to volume (3D) for both tumour and critical normal tissues
      (bladder, rectum, sigmoid mainly). Thus, by repetitive imaging performed before each BT
      treatment it is possible to adapt dose given as per the anatomy of each individual patient
      taking into account not only the position of OAR but also the tumour regression which often
      is obtained by preceding EBRT and chemotherapy. Clinical Outcome data from Vienna, Paris and
      Mumbai have shown potential in improved local control rates with acceptable toxicities so
      far. Prospectively treated more than 100 patients with image based brachytherapy from Vienna
      Group have shown improved local control rates across all stages with decreased toxicity on
      comparisons with historical series of patients treated with Conventional Radiography based BT
      [13-19]. Also, a phase II multicentre intercontinental study using MR Image Based
      Brachytherapy (EMBRACE: European study on MRI-guided Brachytherapy in Locally Advanced
      Cervical Cancer) has been implemented and tested in various centres across the world
      including Tata Memorial Hospital, Mumbai. Over 600 patients have been recruited in the study
      so far. Based on the experience collected so far, the image based BT approach is expected to
      have a major impact on the clinical outcome for II B and III B (increase in local control
      rates by 10-20%) with concomitant decrease in the rates of late normal tissue toxicity (<5%
      Grade ¾), as compared to historical results for point based conventional treatment
      prescriptions [20].

      EMBRACE is a study on MRI guided brachytherapy (BT) in locally advanced cervical cancer.
      Today point-based two-dimensional BT is most often used for definitive radiotherapy in
      cervical cancer. However, MRI guided Image Based brachytherapy is increasingly being used in
      several centres, and the results reported so far are very promising. The major advantage of
      this technique is the possibility to conform the dose given by BT with regard to both volume
      (3D) and time (4D). Thus, by repetitive imaging performed before each BT implant it is
      possible to adapt the dose given by BT to the anatomy of each individual patient taking into
      account not only the position of organs at risk but also the tumour regression which often is
      obtained by preceding external beam radiotherapy and chemotherapy. Based on the experience
      collected so far, the image based BT approach significantly improves the dose-volume
      histogram (DVH) parameters and the improved dose delivered seems to have a major impact on
      the clinical outcome with a concomitant decrease in the rates of both local failure and
      morbidity. Preliminary results of ongoing studies including RETRO EMBRACE (600 patients -
      retrospective multicentric analysis) and EMBRACE (1000 patients recruited so far
      prospectively multicentric) also suggest excellent local control rates & minimal clinical
      significant toxicities.

      Hypothesis: The clinical outcome of radical radiation therapy including Conventional
      radiography based brachytherapy for International Federation of Gynecology and Obstetrics
      (FIGO) Stage IIB and IIIB reported in historical series is 75% and 55% local control rates
      and grade ¾ rectal / bladder toxicities of 10-15%. With the addition of concomitant cisplatin
      chemotherapy there is an additional local control benefit of 5-10% and potentially increase
      in late toxicities (no substantial evidence for toxicities reported so far). With the MR
      Image Based Brachytherapy approach, mono-institutional series and phase II multicentric
      international study, the results reported so far show an improvement in local control rates
      to 96% and 86% for IIB and IIIB respectively and late toxicities <5% reported so far. We
      propose this randomized control study to test the following hypothesis: With the use of MR
      Image Based Brachytherapy (Study Arm) in locally advanced cervical cancers (Stratified for
      Stage IIB and IIIB), there will be an absolute increase in local control rates by 10% and
      reduction in late rectal and bladder toxicities by 5% - 10% as compared to the Conventional
      radiography based ICBT. Thus, for demonstrating absolute local control benefit of 10% in
      Stages IIB (85% to 95%) and Stage IIIB (65% to 75%) a total of 1050 patients (350 patients
      with Stage IIB and 650 patients with stage IIB respectively) will be accrued.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local control
time frame: 2 years
description: Absolute benefit in local control rates by 10% for stages FIGO IIB and IIIB
measure: Late toxicities
time frame: 2 years
description: Reduction in grade 3 and grade 4 (CTCAE) late toxicities from 10% to 5% (by 50%)
measure: Pelvic control rates
time frame: 2 years
measure: Distant failure rates
time frame: 2 years
measure: Progression free & cause specific survival
time frame: 2 years
measure: Overall survival
time frame: 2 years
measure: Quality of life questionnaire EORTC QLQ C30
time frame: 2 years
measure: Quality life questionnaire EORTC QLQ CX24
time frame: 2 years
arm group label: MR based BT
arm group type: Experimental
description: Magnetic Resonance Image based Brachytherapy
arm group label: Conventional BT
arm group type: Other
description: Conventional Radiograph based Brachytherapy
intervention type: Radiation
intervention name: Magnetic Resonance Image based Brachytherapy
description: MRI based BT prescription will be in accordance to the GEC-ESTRO guidelines [Intention will be to treat the whole cervix and the remaining residual tumour tissue at the primary site at the time of BT (high risk-clinical target volume) to a dose level analogue to the dose level previously prescribed for point-A]
arm group label: MR based BT
intervention type: Radiation
intervention name: Conventional Radiograph based Brachytherapy
description: The standard conventional radiography based prescription will be according to Manchester system Point A and bladder & rectum ICRU point dose constraints
arm group label: Conventional BT
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Umesh Mahantshetty, MD, DNB
role: Principal Investigator
affiliation: Professor, Department of Radiation Oncology, Tata memorial Hospital, Mumbai 400012
last name: Umesh Mahantshetty, MD, DNB
phone: +91 2224177000
phone ext: 7168
email: mahantshettyum@tmc.gov.in
facility: 
status: Recruiting
contact: 
country: India
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responsible party type: Principal Investigator
investigator affiliation: Tata Memorial Hospital
investigator full name: Dr Umesh Mahantshetty
investigator title: Professor, Department of Radiation Oncology, Tata Memorial Hospital, Parel, Mumbai 400012
mesh term: Uterine Cervical Neoplasms