Oligometastatic Disease, Metastatic Non Small Cell Lung Cancer
Conditions
Keywords
Local Consolidative Radiation Therapy, Oligometastatic disease, NSCLC, Maintenance therapy, SABR
Brief summary
Standard Maintenance Therapy versus Local Consolidative Radiation Therapy and standard maintenance therapy in 1-5 sites of OligoMetastatic Non-small cell lung cancer (NSCLC): A Phase III Randomized Controlled Trial
Detailed description
Standard of care maintenance therapy alone (standard arm) versus local consolidative radiation therapy and standard of care maintenance therapy (Experimental arm)
Interventions
Local consolidative radiation therapy (LCRT) to all oligo-metastatic sites in addition to primary disease site
DRUGStandard maintenance therapy as decided by the treating medical oncologist
Standard maintenance therapy/Observation
Sponsors
Tata Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase III, Open-label, Randomized controlled trial,
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years 2. Patients with ECOG performance status of 0-2 3. Patients with pathologically proven diagnosis of NSCLC 4. Patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than or equal to 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible) 5. Patients who have received standard duration of systemic therapy (4 - 6 cycles) without progression of the disease 6. Patients suitable for definitive therapy to the primary disease 7. All the Oligometastases lesions should be radiologically visible and suitable for ablative doses of radiation in accordance with the dose fractionation regimens specified in the protocol. 8. Patients who have received ablative radiation therapy or surgery or RFA for metastatic sites at presentation or during systemic therapy will be eligible provided the total number of oligometastatic sites at the time of study entry (treated site included) is less than or equal to five. 9. Patients who have received palliative RT for symptomatic bony metastases or RFA will also be eligible provided the treated site is under control on imaging. If not controlled, could be eligible for study if further ablative doses of radiation can be delivered according to the treating physician. 10. Patients who underwent surgical decompression, or stabilization followed by palliative radiation therapy for bony metastases will be eligible in the study provided the treated site is under control on imaging and patient has less than 5 sites of metastases at the time of study entry. 11. Adequate end organ function CBC/differential obtained within 15 days prior to registration on study, with adequate bone marrow function defined as follows: * Absolute neutrophil count (ANC) ≥ 500 cells/mm3; * Platelets ≥ 50,000 cells/mm3; * Hemoglobin ≥ 8.0 g/dl (Use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable); 12. For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration; 13. Patients willing for written informed consent and must be willing to comply with the specified follow up schedule
Exclusion criteria
1. Patients with progressive disease after initial standard systemic therapy 2. Patients with oncogene driver mutations 3. Patients with more than 5 sites of oligo metastases 4. Patients with metastatic lesion size of more than 5 cm 5. Patients with more than three metastatic lesion in one organ 6. Patients not suitable for definitive radiation therapy to primary disease 7. Patients not suitable for ablative radiation therapy to metastatic sites 8. Patients with malignant peritoneal disease 9. Patients with malignant pleural effusion 10. Leptomeningeal disease 11. Brain metastases in the brain stem 12. Clinical or radiological evidence of spinal cord compression or metastases within 2 mm of spinal cord on MRI 13. Severe, active co-morbidity defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; * Transmural myocardial infarction within the last 6 months; * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; 14. Patients with prior history of radiation therapy to thorax 15. Patients with previous history of malignancy within last 3 years from the date of diagnosis 16. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Upto 2 years | Overall survival is defined as the duration between the date of randomization to the date of death due to any cause or the date of last follow-up, whichever is earlier. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local control rates of treated sites | Upto 2 years | Local control rate will be defined as the absence of progressive disease at the treated sites |
| New distant metastases | Upto 2 years | Time to onset of new distant metastases |
| Health Related QOL using the EORTC-QLQ-C30 questionnaire | From randomization every 3 months till 2 years | To evaluate patient reported outcomes between the two arms |
| Progression free survival (PFS ) | Upto 2 years | Progression free survival is defined as the duration between the date of randomization to the date of first documented progression or death due to any cause or date of last follow-up, whichever is earlier. |
| Response rates | From randomization every 3 months upto 2 years | To compare response rates between the two arms |
| Radiotherapy related toxicity using CTC v5.0 (radiotherapy related acute and late toxicity) | Upto 2 years | At baseline and at subsequent follow up till 2 years |
| Health Related QOL using the EORTC- LC13 questionnaire | From randomization every 3 months till 2 years | To evaluate patient reported outcomes between the two arms |
Countries
India
Contacts
Primary ContactDr. Anil Tibdewal
Backup ContactDr. Jai Prakash Agarwal
Outcome results
None listed