Jhajjar

Researchers are studying stage III non-small cell lung cancer NSCLC to evaluate the feasibility and control of local tumor growth by combining high precision stereotactic body radiotherapy SBRT with chemotherapy. This study aims to improve outcomes for patients with tumors or lymph nodes measuring 6 centimeters or less. The trial builds on evidence that SBRT delivers high doses of targeted radiation with limited toxicity and may improve local control compared to conventional radiotherapy. The treatment being evaluated is SBRT administered to the primary tumor and involved lymph nodes in stage III NSCLC when the tumor size is 6 centimeters or smaller. SBRT delivers high dose radiation in few fractions with sharp dose gradients to minimize damage to surrounding tissues. The study will assess the efficacy and safety of SBRT combined with chemotherapy and monitor outcomes over two years. Participants will be involved in long-term follow-up to track tumor control, survival, toxicity, and quality of life. Assessments include imaging, toxicity grading, and quality of life questionnaires over a two-year period. The primary outcome measured is loco-regional control at two years, with secondary outcomes including disease-free survival, overall survival, toxicity, and quality of life. The study provides close monitoring and aims to evaluate the potential benefits and risks of this treatment approach.

Researchers are evaluating whether skipping postoperative radiotherapy PORT to regional lymph nodes in patients with oral cavity squamous cell carcinoma OCSCC who have pN0 or pN1 neck status can achieve similar treatment outcomes. This phase IIIII randomized trial focuses on patients who have undergone radical surgery with adequate lymph node dissection and have high-risk features such as positive or close margins, lymphovascular or perineural invasion, or advanced primary tumor stage. The study addresses the uncertain benefits and potential side effects of radiotherapy to regional lymphatics in this group. Participants are randomly assigned to one of two groups one receiving standard PORT to both the primary tumor bed and regional lymphatics, and the other receiving PORT only to the primary tumor bed while omitting radiotherapy to regional lymph nodes. Radiotherapy is delivered as intensity-modulated radiation therapy IMRT at doses of 66Gy33 fractions, 60Gy30 fractions, or 50Gy20 fractions. In cases of positive surgical margins, weekly cisplatin chemotherapy is given during radiotherapy. The trial excludes patients with more extensive nodal disease pN2 or pN3 and those requiring re-irradiation. Participants will be monitored over two years to assess regional control of cancer, local control, disease-free survival, overall survival, and treatment-related toxicities including acute and late side effects. Swallowing function and quality of life are also evaluated through questionnaires. The study requires timely initiation of radiotherapy, completion of specific quality of life tools, and long-term follow-up visits. Safety and effectiveness outcomes will help determine if omitting radiotherapy to regional lymphatics is feasible without compromising cancer control.

Researchers are investigating the use of lisaftoclax combined with BTK inhibitors in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma CLLSLL who have previously been treated with BTK inhibitors. This global, open-label, phase III study aims to evaluate the effectiveness and safety of this combination compared to BTK inhibitor alone in patients who have been on BTK inhibitor monotherapy for at least 12 months. About 440 participants will be randomly assigned to one of two groups one will receive lisaftoclax together with a BTK inhibitor, and the other will receive only a BTK inhibitor. The study uses a parallel design where participants are allocated equally to each treatment arm to compare outcomes clearly. Both treatments are administered under medical supervision, and the study is open-label, meaning both the researchers and participants know which treatment is given. Participants will be assessed regularly over the course of the study, with evaluations including disease progression measured at 12 months and overall survival also tracked at 12 months. Eligibility screening includes assessments of performance status, bone marrow, kidney, and liver function, as well as consent to follow the study schedule. The research team monitors safety and treatment effects throughout the trial, which is expected to complete by late 2027.

Researchers are conducting a Phase 1, open-label, dose escalation study to assess the safety, pharmacokinetics PK, and pharmacodynamics PD of an oral drug called AUR112 in patients with relapsed advanced lymphomas. This first-in-human trial aims to find safe and tolerable doses of AUR112 for future studies. The study is led by Aurigene Discovery Technologies Limited and focuses on patients with relapsed or refractory non-Hodgkin lymphoma NHL, chronic lymphocytic leukemia CLL, or Hodgkin disease who have exhausted other effective therapies. Participants will receive AUR112 once daily at increasing dose levels ranging from 100 mg to 1200 mg. The dose escalation follows a classic 33 design, where safety and biological activity data guide dose increases. The study will continue increasing doses until safety limits are reached or biologically active doses are identified. This approach helps determine the most appropriate doses for future clinical trials. During the study, participants will be closely monitored for dose-limiting toxicities and treatment-related adverse events over the first 28 days cycle 1. Researchers will also measure various PK parameters like maximum concentration, time to maximum concentration, and area under the curve on specific days. Assessments include laboratory tests, physical exams, and safety evaluations. The study will help identify doses for further research while ensuring participant safety throughout the trial period.

Researchers are evaluating a new radiation therapy approach called Swallowing and Submandibular Sparing Intensity Modulated Radiotherapy SWOAR IMRT for patients with head and neck squamous cell carcinomas HNSCC of the oropharynx, larynx, and hypopharynx. This phase III trial compares SWOAR IMRT with standard intensity modulated radiotherapy IMRT to see if sparing certain swallowing and aspiration-related structures, as well as one submandibular gland, can reduce swallowing difficulties and aspiration risks. The study also tracks tumor control and survival outcomes over time. Participants receive either standard IMRT combined with radical concurrent chemoradiotherapy or SWOAR IMRT, which adds protection to specific swallowing-related organs and a submandibular gland during radiation treatment. Cisplatin chemotherapy is given weekly during radiation at a dose of 40 mgm2, aiming for a cumulative dose of at least 200 mgm2 if there is margin-positive disease. Treatment is provided according to random assignment, and patients are monitored closely throughout therapy. During the study, swallowing function is assessed using the MD Anderson Dysphagia Inventory MDADI at baseline, treatment completion, and multiple points up to 24 months after radiotherapy. Aspiration risk is evaluated with a swallowing endoscopic exam FEES using a penetration-aspiration score. Acute and late treatment side effects are recorded weekly during therapy and at follow-ups. Tumor recurrence and overall survival are tracked for up to five years. Quality of life is also measured with standardized questionnaires. Participants will be followed for long-term safety and treatment effects.

Researchers are evaluating a shorter, hypo-fractionated radiotherapy schedule compared to the conventional longer course for patients with squamous cell carcinoma of the head and neck following surgery. This study aims to test if reducing the number of radiation fractions by half can control cancer growth as well as the standard treatment. The trial addresses the need for more convenient, resource-saving treatment options, especially valuable in settings with limited radiotherapy availability. The study compares two radiation therapy schedules given after surgery the standard regimen delivering 60 Gy over 30 fractions in 6 weeks, and a hypo-fractionated regimen delivering 4 Gy over 15 fractions in 3 weeks. Both treatments are given five days per week. Advances in radiation delivery techniques allow better targeting of tumors while protecting nearby organs, making hypo-fractionation a feasible option. This approach also aligns with practices in other cancers where shorter radiation courses have shown similar outcomes. Participants will receive their assigned radiotherapy schedule and be followed for up to two years. Researchers will monitor cancer control in the treated area, swallowing function, disease-free survival, overall survival, quality of life, and both short-term and long-term side effects using various toxicity scales. The study includes detailed assessments and long-term follow-up to evaluate the safety and effectiveness of the hypo-fractionated radiation compared to the conventional schedule.