Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: NOT APPLICABLE: NOT APPLICABLE
Intervention2: SBRT: SBRT to the pelvic nodes
Intervention3: Arm B: Intervention Arm (Arm B): Stereotactic Body Radiotherapy (SBRT) boost to pelvic nodes
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older with locally advanced cervical cancer suitable for primary treatment with chemoradiotherapy. Pathologically confirmed carcinoma cervix squamous,adenocarcinoma,adeno-squamous carcinoma histology. Patients with stage IIIC disease, who have not undergone previous pelvic radiation therapy or surgery and have an Eastern Cooperative Oncology Group performance status of 0-2. Patients diagnosed with cervical cancer with pelvic nodal burden less than 3cm or 30cc up to 4 lymph nodes who are eligible for chemo-radiotherapy. Signed informed consent. Adequate end organ function hepatic, renal, cardiac reserve
Exclusion criteria
Exclusion criteria: Patients with stage I or stage II or stage IV disease Patients with prior malignancies or active autoimmune diseases will be excluded from the study. Other histology melanoma, small cell, basal cell carcinoma Previous pelvic radiotherapy, hysterectomy, any form of oncological treatment. Contraindications to CEMRI, brachytherapy Age less than 18 years. Uncontrolled medical comorbidity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to compare the safety profile of SBRT boost vs SIB to pelvic nodes among patients with Stage III-C carcinoma cervix by assessing the acute GI and GU toxicity (Grade 3 GI/GU toxicity) within 30 days of completion of treatment.Timepoint: The toxicity will be assessed at the following time points: baseline, 4 weeks, 3 months, and 6 months post-treatment completion. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the dosimetry of organs at risk between the two study arms. ïâ??· To evaluate the efficacy of SBRT in terms of local control using radiological imaging by assessing the response rates, post-treatment (3 months) using RECIST, PERCIST CriteriaTimepoint: 3 months;NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDR. KARUN KAMBOJ
Outcome results
None listed