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A clinical trial to study the effects of special type of radiation therapy-Intensity modulated radiotherapy and image guided brachytherapy in cervical cancer.

A PROSPECTIVE STUDY OF IMAGE GUIDED INTENSITY MODULATED RADIOTHERAPY(IG-IMRT) AND IMAGE GUIDED BRACHYTHERAPY(IGBT) IN LOCALLY ADVANCED CARCINOMA CERVIX

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027434
Enrollment
20
Registered
2020-08-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C531- Malignant neoplasm of exocervix

Interventions

Intervention1: Image guided intensity modulated radiotherapy and image guided brachytherapy: This will a prospective single arm interventional study. Patients will be treated with whole pelvis Image g

Sponsors

Dr Madhup Rastogi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age: 18-65 years Informed consent from the patient. KPS score 70 or above. Histopathologically proven Squamous Cell Carcinoma of carcinoma from stage IB2 to IVA (FIGO 2018) Routine hematological, renal and hepatic functions should be with in normal range. No contraindications of MRI. No prior chemotherapy or radiotherapy and surgery

Exclusion criteria

Exclusion criteria: Any histopathology other than squamous cell carcinoma. Patient having any synchronous or metachronous malignancy. Patient having pre-existing renal or cardiovascular disease. Patient hypersensitive to cisplatin. Para-aortic lymph node positive. Patient suffering from uncontrolled HIV, Hep B, Hep C. Pregnant or lactating women. Previous pelvic irradiation. Patient with active inflammatory bowel disease.

Design outcomes

Primary

MeasureTime frame
To assess the acute toxicity and to evaluate loco-regional control (LRC) of image guided â??IMRT followed by IGBT in carcinoma cervix patients.Timepoint: 1.LRC will be assessed after 3 months after completion of brachytherapy . 2. Acute toxicity will be assessed weekly during radiation and upto 100 days from start of radiation therapy.

Secondary

MeasureTime frame
To assess the late toxicity and to evaluate the efficacy in terms of disease free survival (DFS)Timepoint: 1.Late toxicity will be assessed 3 months after completion of radiation upto last date of follow up. 2.DFS will be evaluated from date of registration to first recurrence (local/regional/distant)

Countries

India

Contacts

Public ContactDr Vachaspati Kumar Mishra

Dr RMLIMS Lucknow

drmadhup1@gmail.com9418155955

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026