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Image Based Brachytherapy in Locally Advanced Cervical Cancers - a Randomized Controlled Trial (COMBAT-Cx)

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ClinicalTrials.gov Identifier: NCT03005743
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Umesh Mahantshetty, Tata Memorial Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Radiation: Magnetic Resonance Image based Brachytherapy Radiation: Conventional Radiograph based Brachytherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : December 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arm Intervention/treatment
Experimental: MR based BT
Magnetic Resonance Image based Brachytherapy
Radiation: Magnetic Resonance Image based Brachytherapy
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]

Conventional BT
Conventional Radiograph based Brachytherapy
Radiation: Conventional Radiograph based Brachytherapy
The standard conventional radiography based prescription will be according to Manchester system Point A and bladder & rectum ICRU point dose constraints




Primary Outcome Measures :
  1. Local control [ Time Frame: 2 years ]
    Absolute benefit in local control rates by 10% for stages FIGO IIB and IIIB


Secondary Outcome Measures :
  1. Late toxicities [ Time Frame: 2 years ]
    Reduction in grade 3 and grade 4 (CTCAE) late toxicities from 10% to 5% (by 50%)

  2. Pelvic control rates [ Time Frame: 2 years ]
  3. Distant failure rates [ Time Frame: 2 years ]
  4. Progression free & cause specific survival [ Time Frame: 2 years ]
  5. Overall survival [ Time Frame: 2 years ]
  6. Quality of life questionnaire EORTC QLQ C30 [ Time Frame: 2 years ]
  7. Quality life questionnaire EORTC QLQ CX24 [ Time Frame: 2 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo) therapy including MRI guided Brachytherapy.
  • Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
  • Stage IIB/IIIB according to FIGO and tumor node metastasis (TNM) guidelines
  • Suitable for Brachytherapy boost
  • MRI of pelvis at diagnosis is performed
  • MRI, Computed Tomography (CT) or Positron Emission Tomography (PET) -CT of the retroperitoneal space and abdomen at diagnosis is performed to rule out Para-aortic lymph node metastasis.
  • Patient informed consent
  • Pre-treatment Haemoglobin level >10 g/dL

Exclusion Criteria:

  • Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin.
  • Metastatic disease
  • Patients with para-aortic metastatic nodes (stage IVB) to the level of L2 vertebra or further dissemination
  • Previous pelvic or abdominal radiotherapy
  • Previous total or partial hysterectomy
  • Combination of preoperative radiotherapy with surgery
  • Patients receiving BT only
  • Patients receiving EBRT only
  • Patients receiving neoadjuvant chemotherapy
  • Contraindications to MRI
  • Contraindications to BT
  • Active infection or severe medical condition endangering treatment delivery.
  • Pregnant, lactating or childbearing potential without adequate contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005743


Contacts
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Contact: Umesh Mahantshetty, MD, DNB +91 2224177000 ext 7168 mahantshettyum@tmc.gov.in

Locations
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India
Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Umesh Mahantshetty, MD, DNB    +91 2224177000 ext 7168    mahantshettyum@tmc.gov.in   
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
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Principal Investigator: Umesh Mahantshetty, MD, DNB Professor, Department of Radiation Oncology, Tata memorial Hospital, Mumbai 400012

Publications:

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Responsible Party: Dr Umesh Mahantshetty, Professor, Department of Radiation Oncology, Tata Memorial Hospital, Parel, Mumbai 400012, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT03005743     History of Changes
Other Study ID Numbers: TMH-1587
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Keywords provided by Dr Umesh Mahantshetty, Tata Memorial Hospital:
Cervical cancer
Brachytherapy
Conventional planning
MR based Brachytherapy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female