CTRI/2024/04/066094
Not yet recruiting
Phase 2
Assessing the feasibility, toxicities and efficacy of 18-FDG PET CT guided dose optimization for radiotherapy treatment in locally advanced cervix carcinoma- A Prospective Phase 2, Pilot study - NI
The Jawaharlal Institute of Postgraduate Medical Education Research0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
- Sponsor
- The Jawaharlal Institute of Postgraduate Medical Education Research
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Treatment naïve,
- •2\. histopathologically proven carcinoma cervix (squamous/adeno/adeno\-squamous),
- •3\. International Federation of Gynecology and Obstetrics (FIGO) (2018\) stage 1B\-IIIC2 patients,
- •4\. age 18\-60 years,
- •5\. attending gynecological tumor clinics, with ECOG performance status 0\-2,
- •6\. with adequate organ function and planned for definitive treatment with chemoradiotherapy and intracavitary brachytherapy.
- •7\. Adequate organ function at time of participation
Exclusion Criteria
- •1\. Patients with uncontrolled Diabetes mellitus, hypertension
- •2\. Patients with HIV infection, Hepatitis B/C infection/ Active Tuberculosis/ any other systemic infection
- •3\. Previously any pelvic surgery / partial or total hysterectomy
- •4\. Previous pelvic/ abdominal radiotherapy
- •5\. Patients with history of neoadjuvant chemotherapy
- •6\. Patients with history of allergy to iodinated contrast or 18F\-FDG
- •7\. Patients requiring ISBT post external beam radiotherapy treatment
- •8\. Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
- •9\. Pregnancy
- •10\. Patients with bladder or rectal invasion at diagnosis, vesico\-vaginal fistula, or recto\-vaginal fistula at diagnosis or post EBRT
Outcomes
Primary Outcomes
Not specified
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