Jhajjar

Researchers are evaluating the use of high precision stereotactic body radiotherapy (SBRT) combined with chemotherapy for patients with stage III non-small cell lung cancer (NSCLC) where tumors and lymph nodes are 6 cm or smaller. The study aims to test the feasibility of this approach and measure the local and regional control rate over two years. SBRT has shown promise in early-stage NSCLC for delivering high doses of radiation with limited toxicity, and this study explores its potential benefits in more advanced stage III disease. The study involves delivering SBRT to both the primary tumor and involved lymph nodes when the gross disease is smaller than 6 cm. This treatment is given upfront, combined with chemotherapy to improve outcomes. The SBRT approach uses carefully targeted radiation in a small number of sessions to maximize dose to the cancer while limiting exposure to surrounding healthy tissue. The study design focuses on patients with tumors less than 6 cm and lymph node involvement limited to three stations with nodes smaller than 4 cm. Participants will be closely monitored throughout the study and required to attend long-term follow-up visits. Researchers will assess treatment success by measuring loco-regional control rates at two years. Evaluations include clinical status, imaging, and other tests to monitor disease control and any side effects. Safety and tolerability will also be observed, especially considering prior treatments and patient performance status. The study includes adults aged 18 to 75 years with good performance status and confirmed stage III NSCLC meeting the size and node criteria.

Researchers are conducting a phase II/III randomized trial to determine if skipping postoperative radiotherapy (PORT) to regional lymph nodes in patients with oral cavity squamous cell carcinoma (OCSCC) who have pN0 or pN1 neck status results in similar treatment outcomes. The study focuses on patients who have undergone radical surgery and have certain high-risk features that usually indicate the need for PORT to reduce recurrence and improve survival. However, PORT can cause significant side effects, so this trial aims to see if omitting radiation to the regional lymphatics can maintain control while reducing treatment-related complications. Participants will be assigned to one of two groups: one receiving standard intensity-modulated radiotherapy (IMRT) to both the primary tumor site and regional lymphatics, and the other receiving IMRT or brachytherapy only to the primary tumor bed, excluding the regional lymphatics. Radiation doses vary depending on the treatment arm and may include 66Gy in 33 fractions, 60Gy in 30 fractions, or 50Gy in 20 fractions. Cisplatin chemotherapy may also be given weekly during radiation for patients with positive surgical margins. During the study, patients will be closely monitored for regional control of cancer over two years. Researchers will assess treatment outcomes, side effects, and quality of life using questionnaires like the MD Anderson Dysphagia Inventory and EORTC quality of life tools. Long-term follow-up will help determine if omitting radiation to regional lymph nodes is safe and effective. The study requires participants to complete assessments and attend follow-up visits over the course of the study period.

Researchers are evaluating the safety, pharmacokinetics, and pharmacodynamics of oral AUR112 in patients with relapsed advanced lymphomas. This Phase 1, open-label, dose escalation study aims to assess the tolerability of AUR112 and determine the doses suitable for future trials. The study involves patients with relapsed Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Hodgkin disease who have exhausted other effective therapies locally. Participants will receive AUR112 once daily, with dose escalation following a classic 3+3 design. Dose escalation continues until safety limits are reached or pharmacokinetic and pharmacodynamic data indicate a biologically active dose. The study monitors dose limiting toxicities and treatment-related adverse events, alongside detailed pharmacokinetic measurements at specified time points. During the study, participants will be closely monitored through clinical assessments and laboratory tests to evaluate safety and drug behavior in the body. Key outcomes include dose limiting toxicities within the first treatment cycle, adverse events graded by standard criteria, and pharmacokinetic parameters such as maximum concentration and half-life. The study also evaluates safety under fasting and fed conditions over a 28-day treatment cycle.

Researchers are evaluating a new radiation treatment approach for patients with head and neck squamous cell carcinomas affecting the oropharynx, larynx, or hypopharynx. This Phase III trial compares standard intensity-modulated radiotherapy (IMRT) with a specialized IMRT technique that aims to spare swallowing and aspiration-related organs as well as the contralateral submandibular gland. The goal is to reduce swallowing difficulties and aspiration risks after treatment. Participants will be randomly assigned to receive either the swallowing and submandibular gland sparing IMRT combined with radical chemoradiotherapy or standard IMRT with chemoradiotherapy. Chemotherapy with cisplatin may be given weekly during radiation for certain patients. Both treatments involve bilateral neck radiotherapy, and the specialized technique focuses on protecting key structures involved in swallowing. Throughout the study, swallowing function will be assessed using patient questionnaires and clinical evaluations at multiple time points up to two years after treatment. Researchers will also monitor toxicity, tumor control, and survival over several years. Assessments include swallowing function scores, aspiration risk evaluations, acute and late side effects, and tumor recurrence. Study participation requires regular follow-up visits and completion of quality-of-life questionnaires.

The current standard radiotherapy regimen for squamous cell carcinomas of the head and neck in the post operative setting is 60-66Gy in 30-33# delivered in 6 weeks with 5 fractions delivered per week. The aim of this study is to test whether a resource sparing, 3weeks, 15 fraction course of hypo-fractionated radiotherapy is non inferior to the conventional fractionation regimen delivering 30 fractions over6 weeks of post operative radiotherapy (PORT). Hypofractionation is already the standard of care in the treatment of cancers like breast cancer which has evolved from 50 Gy in 25 # to 40 Gy in 15# and finally to 26Gy in 5 # with similar tumor control rates and toxicity profiles. Hypofractionation has shown promising results in prostate, lung cancer and CNS tumors. Hypofractionation has been initially explored in palliative setting for HNSCC. Unlike 2 dimensional RT deliver, recent past has seen a rapid evolution of RT delivery techniques like 3-dimensional conformal radiotherapy (3D CRT), intensity modulated radiotherapy (IMRT), image guided radiotherapy (IGRT), volumetric arc therapy (VMAT). It is now possible to spare adjoining critical organs at risk which make delivery of hypo-fractionated feasible for HNSCC. Recently, the IAEA multicentric trial in radical setting for HNSCC has proved equivalent results in term of both disease control and toxicity with delivery of hypo-fractionated RT. Shorter treatment time is more convenient to the patient. The reduction in the number of fractions required per patient will help in optimal unitization of radiotherapy resources, especially in a low/moderate income country like India where the burden of cancer hugely surpasses the resource availability. Hypo-fractionated schedules have potential to provide attractive cost benefits.