Single procedure brachytherapy in cervical cancer

Phase 1/2

Not yet recruiting

Brief Summary: Cervical cancer is a major health problem in developing world including India. Radical radiation therapy with / without concomitant chemotherapy is the treatment of choice for locally advanced cervical cancers**.** The primary advantage of 3D image guided brachytherapy over conventional 2D system is that it allows the dose to conform to the anatomy of each individual patient while reducing the dose to organs at risk. Our intention is to deliver fractionated treatments in a strict image based and quality controlled environment to minimize the doses to organs at risk. Evaluation of feasibility will be done in phase 1 and 2 setting. Dose constraints to organs at risk will be achieved concomitantly, keeping the inter fraction doses to organs at risk in account. This study is expected to increase ease and acceptability of brachytherapy in patients and with significant saving of resources

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
1)To evaluate feasibility to achieve dosimetric constraints for target and organs at risk, thus safety to deliver multi-fractionated brachytherapy in a single application	1 year

Secondary Outcome Measures

Name	Time	Method
1)To evaluate inter fraction dose variation for organs at risk
To assess clinical outcomes in terms of late Gastrointestinal (GI)/Genitourinary (GU)/vaginal toxicities (grade 3 or more) and local control rates.

Locations (1): Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Umesh Mahantshetty
Principal investigator
022-24177168
drumeshm@gmail.com