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Single procedure brachytherapy in cervical cancer

Phase 1
Conditions
Health Condition 1: null- Cancer of Uterine Cervix
Registration Number
CTRI/2017/03/008172
Lead Sponsor
Tata Memorial Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

1) Histologically diagnosed invasive cervical cancer (squamous carcinoma, adenosquamous carcinoma, adenocarcinoma)

2) FIGO stage II B - IV A after thorough clinical examination and work-up investigation.

3) Suitable for radical radiation therapy with/without chemotherapy, and also for brachytherapy boost.

4)Accepts the Informed consent process and signs the form on his/her will.

Exclusion Criteria

1)Patients with vesico-vaginal fistula or recto-vaginal fistula at diagnosis.

2)Patients at high risk of anaesthesia and patients with phobia /contra-indications to undergo MRI.

3)Patients not suitable for brachytherapy.

4)Metastatic disease beyond iliac on standard imaging.

5)Vault cancers/recurrence.

6)Previous history of pelvic radiation.

7)Non-compliance to treatment.

8)Medical or psychological illness precluding treatment protocol

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1)To evaluate feasibility to achieve dosimetric constraints for target and organs at risk, thus safety to deliver multi-fractionated brachytherapy in a single applicationTimepoint: 1 year
Secondary Outcome Measures
NameTimeMethod
1)To evaluate inter fraction dose variation for organs at risk <br/ ><br>Timepoint: 1 year;To assess clinical outcomes in terms of late Gastrointestinal (GI)/Genitourinary (GU)/vaginal toxicities (grade 3 or more) and local control rates. <br/ ><br>Timepoint: 2 years
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