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

Oligometastatic Disease Clinical Trial

— TARGET-02  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05278052
• Other study ID #: 3445
• Secondary ID: CTRI/2020/04/024
• Status: Recruiting
• Phase: Phase 3
• Start date: April 20, 2020
• Est. completion date: April 20, 2028

Study information

• Verified date: April 2023
• Source: Tata Memorial Hospital
• Contact: Dr. Anil Tibdewal
• Phone: +91-22-24177000
• Email: aniltibdewal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Standard of care maintenance therapy alone (standard arm) versus local consolidative radiation therapy and standard of care maintenance therapy (Experimental arm)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: April 20, 2028
• Est. primary completion date: April 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non Small Cell Lung Cancer
• Oligometastatic Disease

Intervention

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

Locations

Country	Name	City	State
India	Tata Memorial Hospital, Parel	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	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.	Upto 2 years
Secondary	Progression free survival (PFS )	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.	Upto 2 years
Secondary	Local control rates of treated sites	Local control rate will be defined as the absence of progressive disease at the treated sites	Upto 2 years
Secondary	New distant metastases	Time to onset of new distant metastases	Upto 2 years
Secondary	Health Related QOL using the EORTC-QLQ-C30 questionnaire	To evaluate patient reported outcomes between the two arms	From randomization every 3 months till 2 years
Secondary	Health Related QOL using the EORTC- LC13 questionnaire	To evaluate patient reported outcomes between the two arms	From randomization every 3 months till 2 years
Secondary	Response rates	To compare response rates between the two arms	From randomization every 3 months upto 2 years
Secondary	Radiotherapy related toxicity using CTC v5.0 (radiotherapy related acute and late toxicity)	At baseline and at subsequent follow up till 2 years	Upto 2 years

External Links

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