Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Intestinal low dose radiation (1 Gy): In the intervention arm, patients will receive a single fraction of 1 Gy intestinal low-dose radiation (ILDR) directed specifically to the small bo
Sponsors
Sameer Bakhshi
Eligibility
Inclusion criteria
Inclusion criteria: 1. ECOG performance status 0-2 2. Histologically confirmed advanced solid tumor amenable to chemoimmunotherapy in the upfront metastatic setting: Non-small cell lung carcinoma, Bladder carcinoma, Head and neck squamous cell carcinoma, Esophageal carcinoma, oTriple negative breast carcinoma. 3. Six months gap from adjuvant or neoadjuvant chemotherapy in the localized setting 4.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the PFS rate at six months (PFS6). The PFS6 will be defined as the proportion of patients who remain alive and disease-free at six months without disease-progression as confirmed by central radiological review as per iRECIST or death.Timepoint: At Six months | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR, PFS & OS per iRECISTTimepoint: 3 years;ORR per PERCISTTimepoint: 6 months;Safety & tolerability of adding ILDR to standard chemoimmunotherapyTimepoint: 6 months;Impact of ILDR addition to patients health-related quality of lifeTimepoint: 6 months;Relationship between baseline gut microbiome composition and its longitudinal changes with clinical outcomes in the two treatment armsTimepoint: Baseline, prior to chemoimmunotherapy and at 12 weeks;Relationship between baseline plasma metabolome composition and its longitudinal changes with clinical outcomes in the two treatment armsTimepoint: Baseline, prior to chemoimmunotherapy and at 12 weeks | — |
Countries
India
Contacts
Public ContactSameer Bakhshi
Dr BRAIRCH, AIIMS, New Delhi
Outcome results
None listed