Short course external beam radio-chemotherapy and single application brachytherapy for cervical cancer – a Phase II study
- Conditions
- Health Condition 1: C538- Malignant neoplasm of overlappingsites of cervix uteri
- Registration Number
- CTRI/2021/05/033538
- Lead Sponsor
- Homi Bhabha Cancer Hospital and Research Centre unit of Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Women = 18 years of age
2.Histologically proven invasive cancer of the uterine cervix - squamous cell carcinoma, adenocarcinoma or adeno-squamous carcinoma.
3.FIGO 2018 stages IB2-IIIC1 patients after clinical examination and imaging.
4.Those who provide willingness to consent for participation in trial and follow up
1)Patients with radiological FIGO Stage IIIC2 disease (involved para-aortic lymph nodes above the bifurcation of aorta)
2)Patients with recurrent cervical cancers.
3)Previous history of abdominal or pelvic radiation.
4)Previous history of hysterectomy or major abdominopelvic surgery.
5)History of connective tissue disorders.6)Patients with contra-indications to undergo MR imaging (metallic prosthesis, severe claustrophobia etc).
7)Patients with lymph nodes > 3cm in size
8)Patients who receive neo-adjuvant chemotherapy
9)Medical or psychological illness precluding treatment protocol (including renal / hepatic dysfunction, significant cardiac co-morbidities etc, which may preclude delivery of adequate doses of chemotherapy).
10)Pregnant and breast feeding women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pelvic Control (local + regional pelvic nodal)Timepoint: 3 years
- Secondary Outcome Measures
Name Time Method Acute GU, GI and vaginal toxicities (Grade = 3).Timepoint: 6 weeks;Late GU, GI and vaginal toxicities (Grade = 3).Timepoint: 3 years