Health Condition 1: C538- Malignant neoplasm of overlappingsites of cervix uteri
Conditions
Interventions
Intervention1: Image guided radiotherapy and adaptive Brachytherapy: Image guided external radiotherapy and image guided adaptive brachytherapy will be applied for patients with locally advanced cervi
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1.Cancer of the uterine cervix considered suitable for curative treatment with definite radio-chemo therapy including MRI guided brachytherapy 2. Positive biopsy showing squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix. 3.Staging according to FIGO and TNM guidelines.(Stage IB, IIA, IIB, IIIA, IIIB and IVA) 4. MRI of pelvis at diagnosis is performed. 5. MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed. 6. MRI with applicator in place at time of (first) BT will be performed. 7. Para-aortic metastatic nodes below L1-L2 are allowed. 8. Patient informed consent.
Exclusion criteria
Exclusion criteria: 1. Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin. 2. Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix. 3. Metastatic disease above and beyond the retroperitoneal para-aortic L1-L2 interspace. 4. Previous pelvic or abdominal radiotherapy. 5. Previous total or partial hysterectomy. 6. Combination of preoperative radiotherapy with surgery. 7. Patient receiving brachytherapy only. 8. Patient receiving external radiotherapy only. 9. Patients receiving neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40mg/2).However, adjuvant chemotherapy in the form of 4 courses of 3 weekly Carboplatin (AUC 5) and paclitaxel (155mg/m2) is allowed according to the departmental policy. 6. Contra indications to MRI. 7.Contra indications to brachytherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are local control, nodal control, systemic control, overall survival and morbidity and quality of lifeTimepoint: 3 and 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints comprise cancer specific survival, and disease specific survival.Timepoint: 3 and 5 years | — |
Countries
Austria, Denmark, India, Netherlands, Romania, Slovenia, United Kingdom
Contacts
Public ContactDr Raviteja Miriyala
PGIMER Chandigarh
Outcome results
None listed