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

Who is this study for? Patients with oligometastatic non-small cell lung cancer
What treatments are being studied? Local consolidative radiation therapy+Standard maintenance therapy
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Tata Memorial Hospital, Parel
RECRUITING
Mumbai
Contact Information
Primary
Dr. Anil Tibdewal
aniltibdewal@gmail.com
+91-22-24177000
Backup
Dr. Jai Prakash Agarwal
agarwaljp@tmc.gov.in
+91-22-24177000
Time Frame
Start Date: 2020-04-20
Estimated Completion Date: 2028-04-20
Participants
Target number of participants: 190
Treatments
Active_comparator: ARM A: Standard maintenance therapy alone
Maintenance systemic therapy/ observation
Experimental: ARM B: Local consolidative radiation therapy (LCRT)
Radiation therapy to all oligometastatic sites including primary loco-regional disease
Sponsors
Leads: Tata Memorial Hospital

This content was sourced from clinicaltrials.gov

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