Clinical trial evaluating image based external and internal radiotherapy for cervical cancer

Phase 2

• Conditions: Health Condition 1: C538- Malignant neoplasm of overlappingsites of cervix uteri

• Registration Number: CTRI/2018/10/016102
• Lead Sponsor: PGIMER

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: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoints are local control, nodal control, systemic control, overall survival and morbidity and quality of lifeTimepoint: 3 and 5 years

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints comprise cancer specific survival, and disease specific survival.Timepoint: 3 and 5 years