Uterine Cervical Neoplasm

Cervical cancer is the second most common cancer in Indian women, and most patients are diagnosed at advanced stages. The standard treatment for these stages is concurrent chemoradiotherapy, but this can cause long-term side effects such as bladder inflammation, strictures, ulcers, and tissue damage, which negatively impact patients' quality of life. Previous studies have shown that oral sodium-copper-chlorophyllin can help reduce radiation-related side effects in rectal, prostate, and cervical cancer patients. However, no study has compared side effects between patients receiving standard follow-up care and those taking sodium-copper-chlorophyllin during follow-up. We hypothesize that the use of sodium-copper-chlorophyllin as a short-duration adjuvant is associated with reduced incidence of late grade 2 or higher gastrointestinal and genitourinary toxicities compared to patients receiving standard-of-care follow-up.

Background Cervical cancer (CaCu) is the fourth cause of death in women. In patients with locally advanced disease, the treatment of choice is CT/RT, followed by additional boosting with brachytherapy (BT). There is an international decrease in the use of this technique due to financial restrictions. Given the difficulties in using brachytherapy as a boost, several series have described promising results in local control using boost with highly conformal techniques such as stereotactic body radiotherapy (SBRT). On the other hand, prospective studies are scarce and with controversial results. No study has been published that directly compares three-dimensional intracavitary SBRT and BT. In this clinical trial, the researchers aim to demonstrate that boosting with SBRT is not inferior to intracavitary brachytherapy in patients with CC. Methodology Primary Objective: To evaluate the safety and efficacy of concomitant CT/RT followed by Ablative Body Stereotactic Radiotherapy (SBRT) vs Brachytherapy in patients with Cervical Cancer in clinical stage IB3-IIIC1 at INCan. Secondary Objectives: The purpose of this study is to evaluate quality of life, local efficacy (local control and time to local recurrence), overall survival, disease-free survival, and time to distant recurrence. Study Design: SABRVICAL is a meticulously designed randomized two-arm open-label phase II study to compare QT/RT + SBRT vs QT/RT + Brachytherapy. It will include patients with IB3-IIIC1 CaCu \>18 years of age with adequate renal function. They will be randomized 1:1 to the experimental arm or the standard arm. Expected Results and Outlook With this study, we aim to assess that the safety and efficacy of concomitant QT/RT with cisplatin followed by SBRT is not inferior to boost with brachytherapy in patients with CaCu IB3-IIIC1. The potential impact of this study is significant, as it could provide new treatment options for hospitals that do not have brachytherapy or have a prolonged waiting list for this procedure.

This study aims to evaluate the clinical feasibility of first-line immunochemotherapy for stage IVB and recurrent cervical cancer guided by circulating tumor DNA (ctDNA), in order to explore the optimal treatment duration or criteria for discontinuation of first-line immunotherapy in patients with stage IVB cervical cancer or recurrent cervical cancer. To ensure the quality of the study, before the study begins, the research applicant and participants jointly discuss and formulate the research plan. Necessary steps should be taken during the design and implementation stages of the study to ensure that the collected data is accurate, consistent, complete, and credible.

Prevention of cervical cancer with cervical screening is one of the most successful screening activities in medicine. In Sweden, screening was implemented in the 1960s and has since prevented tens of thousands of women from having cervical cancer. Individual invitations to screening result in increased attendance therefore evaluating strategies for reaching women through invitations is particularly valuable. Women who regularly attend screening following an invitation reduce their risk of cervical cancer by as much as 90%. Of the women who are diagnosed with cervical cancer (about 550 women per year in Sweden), as many as 38% did not participate in the screening. Invitations for screening are sent to the entire population in Sweden aged 23-70. The current coverage of screening is 82.9%, which represents the proportion of women ages 23-70 who attend according to recommendations. In addition, many women are sporadic attenders who reduce their risk for cancer somewhat. The highest cancer risk is seen among those women who have never participated as well as women who have had a history of precancerous lesions or HPV infection but have not been followed-up. Cervical cancer is the first form of cancer for which there are approved molecular screening tests (HPV test). Unlike the older screening method (cytology), self-collected samples can be analyzed for HPV (the analysis method is so sensitive that it does not matter if the sample is not optimally taken). Invitations and reminders about cervical screening are sent by letter to the woman's home address (about 3 million letters per year in Sweden). This strategy results in a waste of resources and has a negative environmental impact. Regarding reminders, we have seen in previous research that the effect is not optimal. When sending a physical reminder letter to women who have not participated in more than 10 years (current routine), only 2% of the women invited came for sampling. Reminders with SMS are now standard for many businesses in society, such as car testing or dental appointments. It is inexpensive, saves the environment and there are studies that suggest it is more effective than sending physical letters. In this study, we intend to investigate whether SMS reminders, electronic letters, and physical letters for screening lead to increased participation and thus to a higher proportion of detected, treatable precursors of cervical cancer compared to before.

The goal of the COMBISCREEN project is to develop a fully molecular cervical screening and triage approach that is applicable on self-samples, which are an easily accessible and non-invasive source of biomarkers. The project allows a one-step screening and triage modality and thereby identifies women with clinically relevant disease that are in need of treatment.