NCT03005743Completed
Image Based Brachytherapy in Locally Advanced Cervical Cancers - a Randomized Controlled Trial
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)
Source: ClinicalTrials.gov · Last updated 23 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1050 (estimated)
- First submitted
- 21 Dec 2016
- Start date
- 1 Dec 2016
- Primary completion date
- 28 May 2025
- Lead sponsor
- Tata Memorial Hospital
- Diseases
- Cervical cancer, Childhood cancers
- NCT number
- NCT03005743
What you commit to
- Study type: Interventional
- Planned participants: 1050
- From 1 Dec 2016 to the primary completion date, 28 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin.
- Metastatic disease
- Active infection or severe medical condition endangering treatment delivery.
Other
- Patients with para-aortic metastatic nodes (stage IVB) to the level of L2 vertebra or further dissemination
- Contraindications to MRI
- Contraindications to BT
- Pregnant, lactating or childbearing potential without adequate contraception
Who the study is looking for
- 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
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tata Memorial Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.