None listed
Conditions
Brief summary
The aim of the present study is to evaluate efficacy and safety of dose escalation at parametrium using intensity modulated radiotherapy in cervical cancer patients treated with 2D brachytherapy. The study hypothesis is that increased dose to parametrium will improve disease control with acceptable treatment toxicity.
Interventions
Parametrial simultaneous integrated boost via linear accelerator using intensity modulated radiotherapy or volumetric modulated arc therapy, is delineated by a radiation oncologist and planned by a medical physicist. Prior to treatment delivery performed by radiotherapists, the plan is evaluated by the radiation oncologist. Dose for parametrial simultaneous integrated boost is 55 Gray (Gy) in 25 fractions (5 fractions per week), concomitant with whole pelvic radiation with dose of 50Gy. During and after external beam radiotherapy, brachytherapy is performed with total dose of 7Gy times 4, weekly. The total treatment time should not be more than 56 days. All the treatments are delivered in radiotherapy unit, Vajira Hospital, Bangkok, Thailand. To assess or monitor adherence or fidelity to the intervention, audit of medical records by principal investigator and/or secondary investigator is done. If there is any protocol deviation, the issue will be discussed and informed to the subject(s) involved in order to maintain or improve fidelity.
Sponsors
Study design
Eligibility
Inclusion criteria
squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of uterine cervix FIGO stage IB3-IVa with/without inguinal node metastases aged at least 18 years ECOG 0-2
Exclusion criteria
-other primary malignancies except carcinoma in situ of cervix and basal cell carcinoma of skin -previous hysterectomy -previous pelvic or abdominal radiotherapy