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Recruiting NCT05278052

Standard Maintenance Therapy (SMT) vs Local Consolidative Radiation Therapy and SMT in OM-NSCLC

Phase III Interventional Oligometastatic Disease Metastatic Non Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Local consolidative radiation therapy, Standard maintenance therapy as decided by the treating medical oncologist.
Who it may be relevant to
Registry conditions: Oligometastatic Disease, Metastatic Non Small Cell Lung Cancer. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Radiation Local consolidative radiation therapy
    Local consolidative radiation therapy (LCRT) to all oligo-metastatic sites in addition to primary disease site
  • Drug Standard maintenance therapy as decided by the treating medical oncologist
    Standard maintenance therapy/Observation

Primary outcome measures

  • Overall survival (OS) [Time frame: Upto 2 years]
Secondary outcome measures (7)
  • Progression free survival (PFS ) [Time frame: Upto 2 years]
  • Local control rates of treated sites [Time frame: Upto 2 years]
  • New distant metastases [Time frame: Upto 2 years]
  • Health Related QOL using the EORTC-QLQ-C30 questionnaire [Time frame: From randomization every 3 months till 2 years]
  • Health Related QOL using the EORTC- LC13 questionnaire [Time frame: From randomization every 3 months till 2 years]
  • Response rates [Time frame: From randomization every 3 months upto 2 years]
  • Radiotherapy related toxicity using CTC v5.0 (radiotherapy related acute and late toxicity) [Time frame: Upto 2 years]

Eligibility criteria

Inclusion criteria

  • Age > 18 years
  • Patients with ECOG performance status of 0-2
  • Patients with pathologically proven diagnosis of NSCLC
  • 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)
  • Patients who have received standard duration of systemic therapy (4 - 6 cycles) without progression of the disease
  • Patients suitable for definitive therapy to the primary disease
  • 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.
  • 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.
  • 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.
  • 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.
  • 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);
  • For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration;
  • Patients willing for written informed consent and must be willing to comply with the specified follow up schedule

Exclusion criteria

  • Patients with progressive disease after initial standard systemic therapy
  • Patients with oncogene driver mutations
  • Patients with more than 5 sites of oligo metastases
  • Patients with metastatic lesion size of more than 5 cm
  • Patients with more than three metastatic lesion in one organ
  • Patients not suitable for definitive radiation therapy to primary disease
  • Patients not suitable for ablative radiation therapy to metastatic sites
  • Patients with malignant peritoneal disease
  • Patients with malignant pleural effusion
  • Leptomeningeal disease
  • Brain metastases in the brain stem
  • Clinical or radiological evidence of spinal cord compression or metastases within 2 mm of spinal cord on MRI
  • 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;
  • Patients with prior history of radiation therapy to thorax
  • Patients with previous history of malignancy within last 3 years from the date of diagnosis
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

India · 1 center
  • Tata Memorial Hospital, Parel — Mumbai

Publications

  • 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 PMID 33727268

Identifiers

NCT: NCT05278052 · 3445 · CTRI/2020/04/024761

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗