A study to evaluate the effectiveness and safety of shorter-course radiotherapy given along with chemotherapy in patients with locally advanced cervical cancer

A prospective study to assess the feasibility of hypofractionated external beam radiotherapy with concomitant chemotherapy in patients with locally advanced carcinoma cervix - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/113010

Enrollment

Registered

2026-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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: Hypofractionated external beam radiotherapy with concomitant chemotherapy followed by image guided adaptive brachytherapy in Locally advanced cervical cancer: 40Gy in 16 fractions in 3

Eligibility

Inclusion criteria

Inclusion criteria: Histopathologically confirmed squamous and adenosquamous carcinoma cervix patients Age group 18 to 65 years Eastern Cooperative Oncology Group (ECOG) score of less than equal to 2 Clinical FIGO stage IB3 to IIIB No or controlled comorbidities which may not compromise delivery of protocol defined chemotherapy and radiotherapy

Exclusion criteria

Exclusion criteria: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 3-4 Previous radiotherapy to abdomen or pelvis or previous chemotherapy FIGO Stage IIIC1, IIIC2, IVA and IVB Synchronous malignancy at any other site or any other malignancy in the past five years Any uncontrolled comorbidity which may compromise delivery of protocol defined chemotherapy and radiotherapy e.g., renal disease, cardio-respiratory disease, diabetes mellitus, Pregnancy Connective tissue disorder (e.g., Scleroderma, SLE) Ineligible to receive cisplatin

Design outcomes

Primary

Measure	Time frame
To assess early clinical and radiological tumour response in locally advanced Ca. cervix patients treated with hypofractionated EBRT with concomitant chemotherapy followed by HDR brachytherapy. Assessment done at 3 months after completion of treatmentTimepoint: To assess early clinical and radiological tumour response in locally advanced Ca. cervix patients treated with hypofractionated EBRT with concomitant chemotherapy followed by HDR brachytherapy. Assessment done at 3 months after completion of treatment	—

Measure

Time frame

To assess early clinical and radiological tumour response in locally advanced Ca. cervix patients treated with hypofractionated EBRT with concomitant chemotherapy followed by HDR brachytherapy. Assessment done at 3 months after completion of treatmentTimepoint: To assess early clinical and radiological tumour response in locally advanced Ca. cervix patients treated with hypofractionated EBRT with concomitant chemotherapy followed by HDR brachytherapy. Assessment done at 3 months after completion of treatment

—

Secondary

Measure	Time frame
To assess treatment related acute and late toxicities To evaluate disease free survival at 12 months Timepoint: 12 months	—

Countries

India

Contacts

Public ContactProf Sushmita Pathy

AIIMS, New Delhi

drspathy@gmail.com9811898793

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026