Jales

Researchers are investigating whether patients with locally advanced cervical cancer who still have detectable cell-free human papillomavirus DNA cfHPV-DNA in their plasma after standard treatment may benefit from additional chemotherapy. This trial is a prospective, randomized, multicenter clinical study designed to evaluate adjuvant chemotherapy based on this biomarker. The study focuses on patients who have undergone chemoradiotherapy and have persistent cfHPV-DNA, as this may indicate ongoing disease activity. Participants first receive standard treatment with concomitant chemoradiotherapy, including doses of radiation and weekly cisplatin. Four weeks after completing this treatment, a blood test is conducted to detect cfHPV-DNA in plasma. Patients with positive cfHPV-DNA results are randomly assigned to either receive two additional cycles of adjuvant chemotherapy with cisplatin and gemcitabine or to be monitored without further chemotherapy. Patients in both groups undergo regular follow-up every four months, including plasma cfHPV-DNA testing, CT scans of the chest, MRI scans of the abdomen and pelvis, and clinical and gynecological exams. During the study, participants are closely monitored for progression-free survival, overall survival, treatment response, quality of life, and any toxic effects of treatment. Follow-up assessments occur at regular intervals from 7 to 120 days after treatment. The total duration of participant involvement varies based on follow-up schedules. The study uses a single-blind design and randomized allocation to ensure scientific rigor while maintaining patient safety throughout the trial period.

Researchers are evaluating the best sequence of chemotherapy drugs for treating locally advanced HER2-negative breast cancer. This phase III, open-label, randomized trial includes 494 female patients with invasive breast carcinoma stages IIB to III. The study compares starting treatment with either anthracyclines plus cyclophosphamide or taxanes, with or without carboplatin for triple-negative subtypes, to determine which sequence is more effective. Participants are randomly assigned to one of two treatment groups. One group receives doxorubicin and cyclophosphamide intravenously every 21 days for three cycles, followed by docetaxel every 21 days for four cycles or weekly paclitaxel for 12 weeks. The other group starts with docetaxel or paclitaxel followed by doxorubicin and cyclophosphamide on the same schedule. Other treatments like surgery, radiotherapy, and hormone therapy are given according to usual care and are not part of the study. Throughout the study, participants undergo regular assessments including cardiac function tests such as echocardiogram or MUGA before treatment starts. The main outcome measured is invasive disease-free survival over an average of eight years. The trial monitors patient health and treatment response but does not alter standard post-chemotherapy care. Participation involves signing informed consent and agreeing to use contraception during and after treatment as required.