Elective Lower abdomen vs Pelvis only irradiation in Node positive cervical cancer patients: A Phase III Randomized study [EPIC Study]

Phase 3

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

• Registration Number: CTRI/2022/01/039495
• Lead Sponsor: Institutional Intramural Funds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Biopsy proved cancer of Cervix uteri.

2) Patients with Age more than 18 years or less than 80 years.

3) With Squamous cell carcinoma, Adenocarcinoma, or Adeno-squamous carcinoma histology.

4) Patients with FIGO 2018 Stage IIIC1/ TNM cT2b-4a cN1 M0 (Pelvic LN positive cervical cancer)

established on suitable radiological imaging with atleast one factor:

• Tumor with parametrial invasion (TNM cT2b cN1 M0)

• Tumor extending to lower third of vagina (TNM cT3a cN1 M0)

• Tumor extending to pelvic wall and/or causing hydronephrosis or nonfunctioning kidney (TNM

cT3b cN1)

• Tumor invading the mucosa of the bladder or rectum (TNM cT4a cN1) with mucosal infiltration

<1X1cm.

5) Amenable for Curative Intent treatment.

6) Fit to receive concurrent chemotherapy.

7) Suitable for Brachytherapy boost.

8) Should not be contraindicated for MRI

9) With Informed patient consent.

Exclusion Criteria

1) Patients age less than 18 years or more than 80 years.

2) Patients with Significant Para-aortic LN metastasis and/or increased uptake in PET CECT at

diagnosis.

3) Patients with distant metastasis

4) Previous history of Abdominal or Pelvic radiotherapy

5) Previous history of partial or total hysterectomy

6) Patients who received Neoadjuvant chemotherapy

7) Contraindicated for MRI

8) Severe medical condition impairing complete treatment delivery

9) Patients with immunocompromised states and psychological illness

10) Patients planned only either for EBRT, or Brachytherapy

11) Pregnant and lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified