Clinical Research Directory

A Clinical Trial to Assess the Effectiveness of NRF2 Activator (Oral Sodium-copper- Chlophyllin ) in Locally Advanced Cervical Cancer to Reduce Late Radiotherapy Toxicity.

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.

Clinical Trial of Minimally Invasive Surgery Versus Abdominal Surgery in Patients With Early Stage Cervical Cancer

Cervical cancer is the most common cause of death from gynecological cancer world-wide. With technological innovation, minimally invasive or even non-invasive medical treatment has become a trend. Since the first cases of laparoscopic radical hysterectomy of cervical cancer have been reported in 1992, many single-center observational cohort studies have shown that compared to open abdominal surgery ，minimally invasive surgery (laparoscopic or robotic radical hysterectomy) showed advantages of less blood loss, shorter hospital stay and fewer intraoperative complications, while the 5-year survival and disease-free survival were similar. The NCCN guidelines and ESGO recommendations also clearly indicated that patients with FIGO stage IA2 -IIA cervical cancer could undergo open or laparoscopic/robotic radical hysterectomy. However, in October 2018, the results of two studies published in the《New England Journal of Medicine》have subverted our traditional perception of minimally invasive surgery and caused widespread controversy in the field of gynecologic oncology treatment. Both studies showed that the survival rate in the minimally invasive surgery group was lower than that in the open surgery group. The results of these two studies have brought unprecedented doubts and challenges to the minimally invasive surgery for cervical cancer. The MD Anderson Cancer Center has even stopped minimally invasive surgery for cervical cancer. Several hospitals in Hong Kong have responded similarly. The NCCN guidelines are also quickly updated based on the results of those studies: patients should be informed of the results of this study and doctors should respect the patient's choices. The above research results have also attracted the attention of many gynecological oncologists in the mainland China. Some experts questioned the design of this study design as well as surgical skills. We need to look at these findings cautiously. So, we launched a real-world study of clinical outcomes affected by different surgical treatment for patients of early stage cervical cancer. We plan to recruit 2000 patients with early cervical cancer from 20-30 selected surgical centers nationwide and perform surgery on patients with qualified and experienced doctors.We will inform the patients current status of the study in detail, divide the patients into different observational group according to their choices on surgical methods. The patients will be followed up closely after surgery. We will compare the differences in clinical outcomes between the two surgical methods and conduct subgroup and stratified analysis. We hope that this study can truly reflect the actual status and clinical l level of early cervical cancer treatment in China, and provide a high level of clinical evidence for the treatment of cervical cancer in China .

Cervical Boost by Ablative Stereotactic Radiotherapy (SABR) vs Brachytherapy in Patients With Cervical Carcinoma

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.

Pd-1 Antibody Combined Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer

Cervical cancer is one of the major health problems for chinese women. Besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies. However, not all patients respond well to neoadjuvant chemotherapy. This is an open-label, single-arm, multi-center clinical trial to evaluate whether PD-1 in combination with neoadjuvant chemotherapy will achieve better objective response rate.

ctDNA-guided First-line Immuno-de-escalation Therapy for IVB-stage and Recurrent Cervical Cancer

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.

Research Project on Reminders and Self-Sampling Can Increase Participation in Gynecology Cell Sampling - Preventive Examination Against Cervical Cancer.

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.

Online Adaptive Radiotherapy Cervical Cancer With Reduced Margin for Cervical Cancer

Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning target volume (PTV) margins for cervical cancer. To explore the value of reduced margins in oART for cervical cancer, we conducted a prospective clinical trial to determine the clinical efficacy and toxicity of reduced margins.

Optimal Margin Evaluation of Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

Online adaptive radiotherapy has demonstrated to be feasible to reduce inter-fractional radiotherapy errors as it re-optimizes treatment plan every fraction. To investigate the extent and value of margin reduction，we conduct a prospective clinical trial to determine the optimal margin and toxicity of smaller margin.

Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning target volume (PTV) margins for postoperative treatment of endometrial and cervical cancer. To explore the value of reduced margins in oART for postoperative treatment of endometrial and cervical cancer, we conducted a prospective clinical trial to determine the clinical efficacy and toxicity of reduced margins.

Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples

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.