A Prospective randomized study to compare haematological toxicities and response between two different chemotherapy regimens in chemoradiotherapy treatment of carcinoma of uterine cervix.

A Prospective randomized study to evaluate toxicities and locoregional response between two different concomitant chemoradiotherapy regimens using weekly cisplatin versus weekly cisplatin and paclitaxel in carcinoma of uterine cervix. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072198

Enrollment

134

Registered

2024-08-09

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: Chemotherapy with Cisplatin and Paclitaxel: Patients will be divided into two groups (Arm A and Arm B) before start of study by opaque sealed envelope technique.All the patients in both

Eligibility

Inclusion criteria

Inclusion criteria: 1. Biopsy proven carcinoma cervix 2. Age group – 20 to 65 years 3. Stage of IIB to IV A carcinoma of cervix (Staging will be done according to International Federation of Gynecology and Obstetrics) 4. ECOG Performance score 0,1. 5. Patients who signed informed consent. 6. EBRT treatment under 3DCRT

Exclusion criteria

Exclusion criteria: 1. Biopsy proven carcinoma cervix 2. Age group – 20 to 65 years 3. Stage of IIB to IV A carcinoma of cervix (Staging will be done according to International Federation of Gynecology and Obstetrics) 4. ECOG Performance score 0,1. 5. Patients who signed informed consent. 6. EBRT treatment under 3DCRT

Design outcomes

Primary

Measure	Time frame
1.Grades of hematological toxicity by using Common Toxicity Criteria for Adverse Events (CTCAE) I, Haematological i, Anaemia ii, Absolute Neutrophil Count iii,Thrombocytopenia II, Gastrointestinal i,Vomiting ii,Diarrhoea Timepoint: 1.Patients will be evaluated during the period of Radiotherapy. 2.Haematological parameters will be recorded weekly from the beginning to the end of treatment. 3.Results will be graded according to the CTCAE scoring criteria.	—

Measure

Time frame

1.Grades of hematological toxicity by using Common Toxicity Criteria for Adverse Events (CTCAE) I, Haematological i, Anaemia ii, Absolute Neutrophil Count iii,Thrombocytopenia II, Gastrointestinal i,Vomiting ii,Diarrhoea Timepoint: 1.Patients will be evaluated during the period of Radiotherapy. 2.Haematological parameters will be recorded weekly from the beginning to the end of treatment. 3.Results will be graded according to the CTCAE scoring criteria.

—

Secondary

Measure	Time frame
Locoregional responseTimepoint: Patient will be assessed after 3 months of Radiotherapy by CT scan and will be graded by RECIST criteria	—

Countries

India

Contacts

Public ContactDR BV Subramanian

SRI VENKATESWARA INSTITUE OF MEDICAL SCIENCES

chinthamsaihimavarsha4730@gmail.com7032878555

Outcome results

None listed

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