Clinical trial NCT05278052: Standard Maintenance Therapy (SMT) vs Local Consolidative Radiation Therapy and SMT in OM-NSCLC
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Oligometastatic Disease
Metastatic Non Small Cell Lung Cancer
Keywords: Local Consolidative Radiation Therapy
Oligometastatic disease
NSCLC
Maintenance therapy
SABR
Lead sponsor: Tata Memorial Hospital
Sponsor class: OTHER_GOV
First posted: 2022-03-14
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase III, Open-label, Randomized controlled trial,
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Upto 2 years
Secondary outcomes:
measure: Progression free survival (PFS )
timeFrame: Upto 2 years
measure: Local control rates of treated sites
timeFrame: Upto 2 years
measure: New distant metastases
timeFrame: Upto 2 years
measure: Health Related QOL using the EORTC-QLQ-C30 questionnaire
timeFrame: From randomization every 3 months till 2 years
measure: Health Related QOL using the EORTC- LC13 questionnaire
timeFrame: From randomization every 3 months till 2 years
measure: Response rates
timeFrame: From randomization every 3 months upto 2 years
measure: Radiotherapy related toxicity using CTC v5.0 (radiotherapy related acute and late toxicity)
timeFrame: Upto 2 years
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Tata Memorial Hospital, Parel
state: Maharashtra
Study officials:
affiliation: Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India
name: Dr. Anil Tibdewal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tibdewal A, Agarwal JP, Srinivasan S, Mummudi N, Noronha V, Prabhash K, Patil V, Purandare N, Janu A, Kannan S. Standard maintenance therapy versus local consolidative radiation therapy and standard maintenance therapy in 1-5 sites of oligometastatic non-small cell lung cancer: a study protocol of phase III randomised controlled trial. BMJ Open. 2021 Mar 16;11(3):e043628. doi: 10.1136/bmjopen-2020-043628.