A clinical trial to study outcome of two forms of radiation therapy, extended field and pelvic only, along with chemotherapy in patients with cancer of cervix.

Prophylactic extended field versus pelvic only intensity modulated radiotherapy with concurrent chemotherapy in locally advanced carcinoma cervix: a prospective randomized study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025329

Enrollment

100

Registered

2020-05-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: C538- Malignant neoplasm of overlappingsites of cervix uteri

Interventions

Intervention1: Prophylactic extended field radiation therapy, concurrent chemotherapy: radiation therapy to pelvic tumour, nodes and paraaortic nodes 45 Gy/25 fractions/5 weeks with concurrent weekly

Eligibility

Inclusion criteria

Inclusion criteria: 1. Biopsy proven carcinoma of cervix (squamous, adenocarcinoma or adenosquamous carcinoma) 2. FIGO stage IB3 â?? IIIC1 (FIGO 201816) 3. Negative paraortic nodes on baseline PET/CT 4. Age 18-65 years 5. Karnofsky performance scale > 70 6. Normal Hemogram: a. Hemoglobin >= 10mg/dl b. Total Leukocyte count >= 4,000 cells/mm3 c. Absolute neutrophil count >= 1500 cells/mm3 d. Platelet count >= 100000 cells/mm3 7. Normal liver and kidney function tests 8. Negative pregnancy test for women of child bearing potential 9. Ready to sign informed consent prior to study entry

Exclusion criteria

Exclusion criteria: 1. Any previous malignancy 2. Those who received radiotherapy and/or chemotherapy or underwent pelvic surgery 3. Pregnant and lactating patients 4. Deranged Hemogram, LFT and KFT 5. Positive paraaortic lymph nodes on baseline PET/CT 6. Patients refusing to give written informed consent 7. Uncontrolled diabetes, hypertension 8. Any other co-morbidity hampering radical treatment of cervical cancer

Design outcomes

Primary

Measure	Time frame
Disease free survival (DFS) and loco regional control (LRC)Timepoint: 3 years	—

Secondary

Measure	Time frame
distant disease free survival, paraaortic node failure rates, acute and late gastrointestinal (GI), hematological and genitourinary (GU) toxicitiesTimepoint: 3 years	—

Countries

India

Contacts

Public ContactDr Pavnesh Kumar

All India Institute of Medical sciences, New Delhi

drpavn@gmail.com7838608085

Outcome results

None listed

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