comparison between two different modern techniques of radiotherapy in terms of side effects and disease control in cervical cancer patients.

Phase 2

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

• Registration Number: CTRI/2021/04/032958
• Lead Sponsor: Chittaranjan National Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Histopathology confirmed primary carcinoma of cervix.

2) Histopathology- squamous cell carcinoma.

3) Intact and non-operated cervical carcinoma cases (wherever concurrent chemo-radiotherapy is

indicated).

4) FIGO stage IB3 to IIIB.

5) Age 18 yrs â?? 70 years.

6) No prior history of chemotherapy or pelvic radiotherapy.

7) WHO performance status grade 0 to 2

8) liver function test with in 2 times of upper normal level

9) hematological parameters with in normal limit and kidney function test within normal limit

10) Patients with no history or current clinical evidence of any Hematological or Bleeding

disorders.

11) HBsAG, Anti-HCV, HIV non-reactive patients.

12) No history of drug use which results in Hematological toxicity.

13) The patient who will understand and follow the instructions and must be able to participate in

the study for the entire period.

Exclusion Criteria

1) Age < 18 years and > 70 years.

2) Patients with WHO performance status grade > 2.

3) Post â?? op patients adviced to receive adjuvant radiotherapy.

4) Stages IA1 â?? IB2 and stages IVA-IVB patients.

5) Patients with pelvic and para-aortic nodal disease or who require extended field radiotherapy beyond the pelvis.

6) Patients with deranged liver function test and kidney function test parameters.

7) Severe, active co-morbidity, defined as follows:

A. History of Unstable angina and/or congestive heart failure requiring hospitalization within the last 6months.

B. History of myocardial infarction within the last 6 months.

C. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration to the study.

D. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.

E. Clinical jaundice and/or history of bleeding disorder.

8) Patients who have already received radiation to pelvis and prior history of chemotherapy.

9) Patients not willing to take part in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified