NCT07435623 Late Radiation Toxicities in Cervical and Endometrial Cancer: A Postoperative IMRT/Brachytherapy Study
| NCT ID | NCT07435623 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tata Memorial Hospital |
| Condition | Endometrial Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-05-10 |
| Primary Completion | 2025-07-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-05-10 with a primary completion date of 2025-07-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cervical cancer is the 4th most common cancer in women globally and the 2nd most common in India. In India, between 2018 and 2020, cervical cancer saw a surge of 26,985 from 2018 to 2020. The treatment for cervical cancer depends on the clinical stage. Treatment of early stage cervical cancer (Stage IB1-IIA) includes chemo-radiation or surgery +/- adjuvant (CT)RT and VBT if indicated. The choice of adjuvant treatment relies on identifying specific risk factors. Patients fulfilling Sedli's intermediate-risk criteria, requires pelvic radiotherapy alone and patients with high-risk Peter's criteria, require adjuvant chemoradiation. This risk-based approach helps tailor adjuvant therapies to individual patient. India reported 16,413 new cases and 6,385 deaths of endometrial cancer, with a mortality rate of 0.73%. The primary treatment for endometrial carcinoma is total abdominal hysterectomy with bilateral salpingo-oophorectomy (TAH-BSO). The Adjuvant treatment depends on risk stratification group according to ESGO/ESTRO/ESP guidelines determined through molecular-based risk stratification. Adjuvant treatment includes radiotherapy, chemotherapy, and brachytherapy. To reduce the burden of acute and late toxicity, advanced external radiation techniques like image guided intensity modulated radiotherapy (IG IMRT) are used. IG IMRT have shown their potential to reduce late toxicity in long term survivors compared to 3DCRT technique. Since January 2020, our institution (TATA memorial centre, Mumbai) has incorporated routine IG-IMRT (Image-Guided Intensity-Modulated Radiation Therapy) for treatment of cervical and endometrial cancer. However, no post-implementation assessment of treatment outcomes and potential toxicity has occurred. This is retrospective observational study aims to evaluate the clinical application of IG-IMRT. Primary aim of this study is to audit the 3 years incidence of ≥ grade II Gastrointestinal \& Genitourinary toxicities in women receiving Adjuvant IMRT (with or without chemotherapy) between January 2020 to June 2023
Eligibility Criteria
Inclusion Criteria: * Patients more than 18 years of age at the time of diagnosis. * All patients with confirmed histological diagnosis of cervical or endometrial cancer. * Only those patients who have received adjuvant (chemo)radiotherapy with IMRT and/or brachytherapy at TMH/ACTREC will be included. * Patients whose follow up information available Exclusion Criteria: * Patients with incomplete treatment details. * Patient having residual disease post-surgery. * Patient treated for post-operative recurrences. * Patient who lost to follow up. * Patients with Immunosuppressive disorder
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07435623 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07435623 currently recruiting?
Yes, NCT07435623 is actively recruiting participants. Contact the research team at supriyasastri@gmail.com for enrollment information.
Where is the NCT07435623 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT07435623 clinical trial?
NCT07435623 is sponsored by Tata Memorial Hospital. The trial plans to enroll 300 participants.
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