Assessing the practical usage, safety and efficiency of PET CT in dose optimization for radiotherapy treatment in locally advanced cervix carcinoma.

Phase 2

• Conditions: Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified

• Registration Number: CTRI/2024/04/066094
• Lead Sponsor: The Jawaharlal Institute of Postgraduate Medical Education Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess proportions of patients achieving hard dose constraints for target and OAR Doses <br/ ><br> <br/ ><br>To assess the proportions of patients developing grade 3 acute toxicity during or till 3 months post treatmentTimepoint: 3 months

Secondary Outcome Measures

Name	Time	Method
To assess PET based disease remission status at 3 months <br/ ><br> <br/ ><br>To assess the proportions of patients developing more than grade 3 late toxicities at 6 months and at 1 year <br/ ><br> <br/ ><br>To assess disease free survival at 1 year <br/ ><br> <br/ ><br>To assess proportions of patients achieving soft constraints for target and OAR Doses <br/ ><br> <br/ ><br>To assess Change in EORTC-QOL score from baseline to 3 months, 6 months and 1 year post treatment.Timepoint: 1 year