Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: Extended field Radiation therapy: Arm 1 [Experimental Arm]- Lower Para-aortic LN irradiation (Below Left renal vein till L2
vertebrae) + Pelvic LN irradiation + Primary disease along w
Sponsors
Institutional Intramural Funds
Eligibility
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study will be the 3-year Disease free survival (DFS), which includes relapse, second cancer, or death due to disease which will be defined as the time (in months) from the date of randomization.Timepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints will be 3-year Para-aortic Recurrence-free survival (PARFS), 3-year Distant metastasis failure-free survival (DMFS), 3-year overall survival (OS), Quality of life analysisusing EORTC QLQ C30 and and EORTC QLQ CX24 questionnaire, and Acute and Late toxicity assessment with CTCAE v5.0 (Common Terminology Criteria for Adverse Events) which will be defined as the time (in months) from the date of randomizationTimepoint: 3 years | — |
Countries
India
Contacts
Public ContactAbhishek Shinghal
Tata Memorial Centre Varanasi
Outcome results
None listed