Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Control Intervention1: comparison between 2 types of radiotherapy techniques in two arms i.e. 3D Conformal Radiotherapy and Intensity Modulated Radiotherapy(using VMAT technique): To assess toxicity a
Sponsors
Chittaranjan National Cancer Institute
Eligibility
Inclusion criteria
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
Exclusion criteria: 1) Age 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) To compare acute hematological, gastro-intestinal and genitourinary toxicities between IMRT (using VMAT technique) and 3DCRT in patients of cervical cancer (FIGO stage IB3-IIIB). 2) To compare loco-regional response between IMRT (using V-MAT technique) and 3DCRT in cervical cancer (FIGO stage IB3-IIIB). Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To compare overall treatment time during EBRT due to toxicity between IMRT (using VMAT technique) and 3DCRT in cervical cancer (FIGO stage IB3-IIIB). 2) To compare disease free survival between IMRT (using VMAT technique) and 3DCRT in cervical cancer (FIGO stage IB3-IIIB), within the short time span of the study. Timepoint: 3 years | — |
Countries
India
Contacts
Public ContactSujan Kumar Ghosh
Chittaranjan national cancer institute
Outcome results
None listed