A clinical trial to study outcome of two forms of radiation therapy, extended field and pelvic only, along with chemotherapy in patients with cancer of cervix.
- Conditions
- Health Condition 1: C538- Malignant neoplasm of overlappingsites of cervix uteri
- Registration Number
- CTRI/2020/05/025329
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Biopsy proven carcinoma of cervix (squamous, adenocarcinoma or adenosquamous carcinoma)
2.FIGO stage IB3 â?? IIIC1 (FIGO 201816)
3.Negative paraortic nodes on baseline PET/CT
4.Age 18-65 years
5.Karnofsky performance scale > 70
6.Normal Hemogram:
a.Hemoglobin >= 10mg/dl
b.Total Leukocyte count >= 4,000 cells/mm3
c.Absolute neutrophil count >= 1500 cells/mm3
d.Platelet count >= 100000 cells/mm3
7.Normal liver and kidney function tests
8.Negative pregnancy test for women of child bearing potential
9.Ready to sign informed consent prior to study entry
1.Any previous malignancy
2.Those who received radiotherapy and/or chemotherapy or underwent pelvic surgery
3.Pregnant and lactating patients
4.Deranged Hemogram, LFT and KFT
5.Positive paraaortic lymph nodes on baseline PET/CT
6.Patients refusing to give written informed consent
7.Uncontrolled diabetes, hypertension
8.Any other co-morbidity hampering radical treatment of cervical cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival (DFS) and loco regional control (LRC)Timepoint: 3 years
- Secondary Outcome Measures
Name Time Method distant disease free survival, paraaortic node failure rates, acute and late gastrointestinal (GI), hematological and genitourinary (GU) toxicitiesTimepoint: 3 years