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

NCT ID: NCT05278052

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-20
• Study Completion Date: 2028-04-20

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)

Conditions

Oligometastatic Disease; Metastatic Non Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARM A: Standard maintenance therapy alone

Maintenance systemic therapy/ observation

Group Type: ACTIVE_COMPARATOR

Standard maintenance therapy as decided by the treating medical oncologist

Intervention Type: DRUG

Standard maintenance therapy/Observation

ARM B: Local consolidative radiation therapy (LCRT)

Radiation therapy to all oligometastatic sites including primary loco-regional disease

Group Type: EXPERIMENTAL

Local consolidative radiation therapy

Intervention Type: RADIATION

Local consolidative radiation therapy (LCRT) to all oligo-metastatic sites in addition to primary disease site

Standard maintenance therapy as decided by the treating medical oncologist

Intervention Type: DRUG

Standard maintenance therapy/Observation

Interventions

Local consolidative radiation therapy

Local consolidative radiation therapy (LCRT) to all oligo-metastatic sites in addition to primary disease site

Intervention Type: RADIATION

Standard maintenance therapy as decided by the treating medical oncologist

Standard maintenance therapy/Observation

Intervention Type: DRUG

Other Intervention Names

LCRT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tata Memorial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anil Tibdewal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Anil Tibdewal

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India

Locations

Tata Memorial Hospital, Parel

Mumbai, Maharashtra, India

Site Status: RECRUITING

Countries

India

Central Contacts

Dr. Anil Tibdewal

Role: CONTACT

aniltibdewal@gmail.com

+91-22-24177000 ext. 7030

Dr. Jai Prakash Agarwal

Role: CONTACT

agarwaljp@tmc.gov.in

+91-22-24177000 ext. 6791

Facility Contacts

Dr. Anil Tibdewal, MD

Role: primary

aniltibdewal@gmail.com

+91-22-24177000 ext. 7030

References

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.

Reference Type: BACKGROUND

PMID: 33727268 (View on PubMed)

Related Links

https://doi.org/10.1136/bmjopen-2020-043628

Related Info

Other Identifiers

CTRI/2020/04/024761

Identifier Type: REGISTRY

Identifier Source: secondary_id

3445

Identifier Type: -

Identifier Source: org_study_id