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Survival Outcomes clinical trials

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NCT ID: NCT06466902 Recruiting - Gastric Cancer Clinical Trials

Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastrectomies for Gastric Cancer (PhotoNodes)

PhotoNodes
Start date: December 22, 2022
Phase:
Study type: Observational

Even after the wide introduction of chemo/radiotherapy in the treatment algorithm, adequate surgery remains the cornerstone of gastric cancer treatment with curative intent. A proper D2 lymphadenectomy is associated with improved cancer specific survival as confirmed in Western countries by fifteen-year follow-up results of Dutch and Italian randomized trials. In clinical practice, the total number of harvested lymph nodes is often considered as a surrogate marker for adequate D2 lymphadenectomy; nonetheless, the number of retrieved nodes does not necessarily correlate with residual nodes, which intuitively could represent a more reliable marker of surgical adequacy. The availability of an efficient tool for evaluating the absence of residual nodes in the operative field at the end of node dissection could better correlate with survival outcomes. The goal of this multicentric observational prospective study is to test the reliability of a new score (PhotoNodes Score) created to rate the quality of the lymphadenectomy performed during minimally invasive gastrectomy for gastric cancer. The score is assigned by assessing the absence of residual nodes at the end of node dissection on a set of laparoscopic/robotic high quality intraoperative images collected from each patient undergoing a minimally invasive gastrectomy with D2 node dissection. Ideally, this tool could be a new indicator of the quality of D2 dissection and could assume a prognostic role in the treatment of gastric cancer.

NCT ID: NCT05311579 Recruiting - Chemotherapy Clinical Trials

Niraparib Plus Anlotinib for Recurrent Ovarian Cancer

Start date: March 27, 2022
Phase: Phase 2
Study type: Interventional

This is a phase II trial to explore efficacy and safety of niraparib in combination with anlotinib based on CA 125 level in newly diagnosed ovarian cancer. After completion of 1st-line platinum-based chemotherapy with a normal CA-125 concentration, in patients with CA-125 increased > 35U/ml, and with no evidence of imaging recurrence, niraparib and anlotinib are used as 1st maintenance therapy for newly diagnosed advanced ovarian cancer after achieving complete or partial remission to platinum-containing chemotherapy. The primary objective of this study is to explore the efficacy of niraparib combined with anlotinib based on CA 125 level in newly diagnosed ovarian cancer with no evidence of imaging recurrence. A total o f36 patients will be enrolled in this study.

NCT ID: NCT05311566 Recruiting - Immunotherapy Clinical Trials

PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer

Start date: March 27, 2022
Phase: Phase 2
Study type: Interventional

This study is a single-center, single-arm, open-phase II clinical study, the main purpose of which is to evaluate the effectiveness and safety of camrelizumab combined with concurrent chemoradiotherapy for early and locally advanced cervical cancer, i.e., FIGO 2018 IB2-IIIB cervical cancer. Eligible subjects will be given cisplatin and radiotherapy, for 6-8 weeks, camrelizumab repeated every 14 days until disease progression, toxicity intolerance, or other reasons specified in the protocol. Subjects who finished treatment entered the safety follow-up or survival follow-up.

NCT ID: NCT05310383 Recruiting - Immunotherapy Clinical Trials

Tislelizumab and Radiotherapy for Recurrent Cervical Cancer

Start date: March 27, 2022
Phase: Phase 2
Study type: Interventional

This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel plus bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. The total treatment periods are no more than 6 cycles. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.

NCT ID: NCT05310357 Recruiting - Clinical trials for Epithelial Ovarian Cancer

Chromosomal Instability in Ovarian Cancer

Start date: March 26, 2022
Phase:
Study type: Observational

Chromosomal instability (CIN) refers to the ongoing genomic change, which involves the amplification or deletion of chromosome copy number or structure. The changes rang from point mutation to small-scale genomic change and even the change of whole chromosome number. It has been reported that the characteristics of genomic rearrangement can be used as a marker of clinical outcome of high-grade serous ovarian cancer, and specific genomic rearrangement are related to the poor prognosis. In noninvasive gene detection with low coverage, patients diagnosed with ovarian cancer have deteriorating progression-free and overall survivals regardless of the tumor stage when somatic copy number distortion (sCNA) exceeds the threshold in plasma. The detection rate of sCNA increased along with the tumor stage. We enrolled those as our target patients, who are diagnosed with high-grade serous ovarian cancer and willing to take part in. The CIN in peripheral cell-free DNA was observed before initial treatment, after primary debulking or staging surgeries, before recurrence and during the process of recurrence treatment. Our aim is to explore the application of CIN in peripheral tumor DNA in the detection of minimal residual lesions (MRD) after primary treatment and recurrence monitoring.

NCT ID: NCT05310344 Recruiting - Clinical trials for Recurrent Ovarian Carcinoma

Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer

Start date: March 27, 2022
Phase: Phase 2
Study type: Interventional

This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel combined with bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.

NCT ID: NCT05310331 Recruiting - Chemotherapy Clinical Trials

Donafenib for Recurrent Cervical Cancer

Start date: March 27, 2022
Phase: Phase 2
Study type: Interventional

This study is to evaluate the safety and tolerability of Donafenib combined with paclitaxel and platinum ± programmed death 1 monoclonal antibody (PD-1 antibody) in patients with recurrent cervical cancer.

NCT ID: NCT05310318 Recruiting - Recurrence Clinical Trials

Prognosis of Low-grade Endometrial Stromal Sarcoma

Start date: March 26, 2022
Phase:
Study type: Observational

This study is to investigate the survival outcomes and fertility outcomes in patients with uterine low-grade endometrial stromal sarcoma (LGESS) treated in Peking Union Medical College Hospital. All primary and recurrent LGESS patients will be enrolled. The study will collect retrospectively data consisting of epidemiological characteristics, surgical, medical treatment and adjuvant therapy. Details about recurrence, mortality, pregnancy and obstetrical outcomes are also followed as primary endpoints. Fertility-sparing procedures, including uterine-sparing and ovary-sparing surgeries will be recorded specifically.

NCT ID: NCT04426136 Not yet recruiting - Breast Cancer Clinical Trials

A Prospective Cohort Study Comparing Disparity in Surgical Procedure (Wide Local Excision Only vs Any Other Surgery Procedures) Among the Elderly Breast Cancer Patients

Start date: June 2020
Phase:
Study type: Observational [Patient Registry]

The incidence and mortality rates of breast cancer are still increasing in both developing and developed countries. The number of women ≥70 years who are affected by breast cancer (BC) worldwide is also on the increase. Based on the largest population and increasing aging, BC is also rapidly increasing among the elderly in China. According to the epidemiological profile data regarding BC in China, the second onset age peak of BC morbidity occurred after 70 years old and in 2020, the proportion of patients older than 65 is expected to exceed one-fifth and reach 27.0% by 2030. However, some controversies remain to be resolved due to the lack of high quality evidence. The tumor biological behavior, treatment choice and treatment tolerance among the elderly prominently differ from their young counterparts. Besides, they are rarely enrolled in large-scale randomized clinical trials or prospective cohort studies and the results are obtained mainly from retrospective studies. Also, frequent deviations from the standard guidelines lead to insufficient or excessive treatments, though the so-called standard guidelines are based on the clinicopathological characteristics and research findings among the younger BC patients. Studies focusing on the global population confirmed that the biological behavior of tumors among elderly patients was more favorable compared with younger patients but did not transform into survival benefits eventually. Numerous prospective, randomized trials have demonstrated that breast conserving surgery (BCS), consisting of segmental mastectomy and radiation treatment with or without axillary lymph node dissection (ALND), is equivalent to mastectomy in terms of overall survival (OS) and disease free survival (DFS) for patients with early stage breast carcinoma. Presentation of the ACOZOG-Z011 study results in 2011 resulted in a downward trend in the use of a completion axillary lymph node dissection in early breast cancer patients with 1-2 positive sentinel lymph nodes (SLN), treated with wide local excision (WLE) and whole breast irradiation. However, there is little evidence regarding the optimal axillary treatment in elderly breast cancer patients, since these patients are often excluded from clinical trials. We had done a retrospective study of breast cancer in the elderly, which demonstrated that those who with complex comorbidities receiving wide local excision merely were about 1.5 times more than those who without (71.2% vs 46.0%, p<0.001). However, it is paradoxical that, on the one hand, the risk of dying from breast cancer may increase if patients do not receive the standard treatment; on the other hand, they could not live long enough to benefit or even suffer more from the standard treatment. The key is to figure out who they are. Given the high proportion of patients treated only with WLE, we believe that it is important to compare the effects of different surgical procedures on prognosis among the elderly BC patient in a prospective cohort study, to be more specific, comparing the WLE versus any other surgical procedures.