Maintenance Chemotherapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Chemotherapy for Stage IV Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II Trial

NCT02045446 | Completed Phase 2 Results DMC

• 1 other identifier: STU 092013-070
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The core hypothesis to be tested is that the use of consolidative SBRT followed by maintenance chemotherapy in patients with less than or equal to 6 metastatic sites (primary + 5) will improve progression free survival (PFS) compared to maintenance chemotherapy alone.

Conditions

Stage IV Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Evaluate the effect of SBRT with maintenance chemotherapy versus maintenance chemotherapy alone on progression free survival. Time to the development of new lesions, progression of existing lesions, or death, whichever came first, represented the primary end point of progression-free survival. All evaluations of disease response used RECIST (v1.1) criteria, in which progressive disease is defined as "At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."

  5 years

Secondary Outcomes (4)

• In-field Local Control Versus Out-of-field Disease Progression

  5 years

• Toxicities

  2 years

• Overall Survival

  5 years

• Duration of Maintenance Chemotherapy

  5 years

Study Arms (2)

Maintenance chemotherapy

ACTIVE COMPARATOR

FDA approved drugs for the study population: Bevacizumab, Docetaxel, Erlotinib, Gemcitabine, Pemetrexed

Drug: Maintenance chemotherapy

Stereotactic Body Radiation Therapy

EXPERIMENTAL

consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy

Radiation: Stereotactic Body Radiation Therapy; Drug: Maintenance chemotherapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

Also known as: SBRT

Stereotactic Body Radiation Therapy

Maintenance chemotherapy DRUG

Maintenance chemotherapy

Maintenance chemotherapy; Stereotactic Body Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have biopsy proven metastatic NSCLC (Stage IV).
• Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response.
• Patients receiving first-line erlotinib, crizotinib for EGFR mutant-positive or EML4-ALK positive NSCLC will be excluded.
• Age ≥ 18 years
• Patients must have measurable disease at baseline.
• Patients can have up to only 6 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by diagnostic CT or PET/CT scan or MRI within 8 weeks prior to the initiation of SBRT.
• For patients who have received prior radiotherapy to the primary site in the lung, residual PET activity is difficult to interpret and will not be considered a site of active disease if the CT appearance is stable or improved over an interval of at least three months
• Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
• Patients with previously un-irradiated primary sites will be potentially eligible, but special considerations apply (section 4.3.2).
• Up to 2 contiguous vertebral metastases will be considered a single site of disease.
• Patients must have a KPS \>60
• AST, ALT \& Alkaline phosphates must be ≤ 2.5X the upper limit of normal. Total bilirubin must be within the limit of normal.
• Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
• Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN).
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

You may not qualify if:

• Patients who previously received radiotherapy to the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapy.
• Patients with untreated brain metastases Patients with serious, uncontrolled, concurrent infection(s).
• Significant weight loss (\>10%) in the prior 3 months.
• Because the tolerance dose of SBRT to the gastrointestinal tract is not established, patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible.
• Patients with cutaneous metastasis of NSCLC.
• Patients with more than 6 discrete extra-cranial lesions.
• Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
• Unwillingness to participate or inability to comply with the protocol for the duration of the study.
• Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Iyengar P, Wardak Z, Gerber DE, Tumati V, Ahn C, Hughes RS, Dowell JE, Cheedella N, Nedzi L, Westover KD, Pulipparacharuvil S, Choy H, Timmerman RD. Consolidative Radiotherapy for Limited Metastatic Non-Small-Cell Lung Cancer: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2018 Jan 11;4(1):e173501. doi: 10.1001/jamaoncol.2017.3501. Epub 2018 Jan 11.

  PMID: 28973074 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery; Maintenance Chemotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Drug Therapy

Results Point of Contact

• Title: Dr. Puneeth Iyengar
• Organization: University of Texas Southwestern Medical Center

puneeth.iyengar@utsouthwestern.edu

214/645-7603

Study Officials

• Puneeth Iyengar, MD

  UTSW

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR, Radiation Oncology - RO-Radiation Oncology

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 24, 2014
• Study Start: February 1, 2014
• Primary Completion: February 17, 2022
• Study Completion: May 2, 2022
• Last Updated: May 23, 2023
• Results First Posted: April 7, 2023

Record last verified: 2023-04

Locations

US (1)