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Investigation on the role of ultra fractioned low dose radiation and chemotherapy in lower part (neck) of the womb

A prospective phase II study to assess the feasibility, efficacy and tolerance of neoadjuvant Chemotherapy with ultra fractionated radiotherapy prior to definitive chemoradiation in stage IIB, IIIA and IIIB Squamous cell carcinoma of cervix - LDRTCX

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/01/002358
Enrollment
20
Registered
2012-01-20
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: null- Women with histologically proven diagnosis of squamous cell carcinoma cervix FIGO stage IIB to IIIB will be included in the study.

Interventions

Intervention1: Chemotherapy with low dose radiation therapy: Neoadjuvant chemotherapy with ultrafractionated radiotherapy Inj Paclitaxel 175mg/m2, on day 1 of each cycle Inj Carboplatin AUC Ã? 5, on d

Sponsors

Fluid Research Grant CMC Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. Inclusion Criteria: Women with histologically proven diagnosis of squamous cell carcinoma cervix FIGO stage IIB to IIIB will be included in the study. Inclusion criteria 1. Age less than or equal to 70 years 2. ECOG less than or equal to 2 3. Pretreatment Hb more than 9 gm% 4. Leucocytes more than or equal to 4000 / mm3 5. Platelets more than or equal to 1,00,000/mm3 6. Normal hepatic and renal parameters

Exclusion criteria

Exclusion criteria: Patients with renal, hepatic or cardiac co-morbidities or previous history of chemotherapy/radiation therapy/malignancy will be excluded

Design outcomes

Secondary

MeasureTime frame
To assess efficacy of Neoadjuvant chemotherapy in combination with low dose radiotherapy in locally advanced Squamous cell carcinoma of cervix in terms of local control and overall survival at 1 yearTimepoint: 1 year

Primary

MeasureTime frame
Assess safety of using neoadjuvant chemotherapy with low dose radiation in locally advanced Squamous cell carcinoma of cervixTimepoint: during the phase of treatment

Countries

India

Contacts

Public ContactSaikat Das

Christian Medical College Vellore

saikat@cmcvellore.ac.in04162282046

Outcome results

None listed

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