Comparison of two radiotherapy types- only PELVIC and EXTENDED in cervical cancer patients

Extended field versus pelvic only Intensity modulated radiotherapy with concurrent chemoradiotherapy in stage III cervical cancer patients- a prospective randomized phase III study - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/071920

Enrollment

116

Registered

2024-08-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Extended field IMRT: EF-IMRT arm ( Extended field IMRT arm)- patients would receive radiotherapy by IMRT technique to include pelvis and para-aortic regions to a dose of 46-50 Gray/ 2

Eligibility

Inclusion criteria

Inclusion criteria: Biopsy proven Carcinoma cervix (squamous, adeno or adeno-squamous) stage III (IIIA, IIIB, IIIc1) Karnoffsky performance status more than 70.Normal Hemogram-Hemoglobinmore than8 g/dl, Total Leukocyte count more than 4,000 cells/mm3, Absolute neutrophil count more than 1500 cells/mm3, Platelet count more than 100000 cells/mm3.Normal liver and kidney function tests (urea less than 40, Creatinine less than 1.2 mg/dl).Negative pregnancy test for women of child bearing potential.Willing to sign the written informed consent prior to study.No other synchronous malignancy

Exclusion criteria

Exclusion criteria: 1. Positive para-aortic LN’s on imaging (i.e. stage IIIC2) 2. Uncontrolled diabetes or hypertension 3. Previous history of receiving radiotherapy 4. Underwent surgical management for carcinoma cervix

Design outcomes

Primary

Measure	Time frame
To assess and compare locoregional control in both arms (using RECIST criteria1.1Timepoint: 3months, 1 year, 2years,3years	—

Secondary

Measure	Time frame
2. To assess and compare disease free survival and overall survival in both arms (DFS- defined as the time from randomization to recurrence of tumor) (OS- defined as the time from randomization to death) Timepoint: 3 years;5. To assess and compare para-aortic failure rate in both armsTimepoint: 3 years;To assess and compare normal tissue toxicities in both arms (using NCT-CTCAE version 5)Timepoint: during RT 5th week, 3 months, 1 year,3 years	—

Measure

Time frame

2. To assess and compare disease free survival and overall survival in both arms (DFS- defined as the time from randomization to recurrence of tumor) (OS- defined as the time from randomization to death) Timepoint: 3 years;5. To assess and compare para-aortic failure rate in both armsTimepoint: 3 years;To assess and compare normal tissue toxicities in both arms (using NCT-CTCAE version 5)Timepoint: during RT 5th week, 3 months, 1 year,3 years

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Countries

India

Contacts

Public ContactDeepika Malik

Sri Aurobindo Medical College and PG Institute

drdeepikamalik36@gmail.com08600033246

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026