Surgery and/or Radiation Therapy or Standard Therapy and/or Clinical Observation in Treating Patients With Previously Treated Stage IV Non-small Cell Lung Cancer

NCT01725165 | Completed Phase 2 Results

• 2 other identifiers: 2012-0618NCI-2012-02874
• Study Type: interventional
• Target: 85
• Locations: 2 countries
• Sites: 3

Brief Summary

This randomized phase II trial studies how well surgery and/or radiation therapy or standard therapy and/or clinical observation works in treating patients with previously treated stage IV non-small cell lung cancer. Radiation therapy uses high energy x-rays to kill tumor cells. Giving surgery and/or radiation therapy may be more effective than standard therapy and/or clinical observation in patients with previously treated non-small cell lung cancer.

Conditions

Recurrent Lung Non-Small Cell Carcinoma; Stage IV Non-Small Cell Lung Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  The measurement of overall survival of patients from the start of trial participation until the time their disease progresses or death of the patient. The outcome measures were stratified per the randomization on protocol. The results were not reclassified based on later sequencing. This was all done in accordance to the protocol document.

  16.6 months to 41.2 months for all patients in both LCT and MT/O group

Secondary Outcomes (1)

• Time to New Lesion Progression

  5.7 to 24.3 months (LCT group); 4.4 to 8.3 months (MT/O group)

Study Arms (2)

Arm I (immediate LCT)

EXPERIMENTAL

Patients undergo ablation of all residual local and metastatic sites of disease by surgery and/or EBRT. After completion of LCT, patients undergo either surveillance or maintenance treatment at the discretion of the treating physician.

Radiation: External Beam Radiation Therapy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Procedure: Therapeutic Conventional Surgery

Arm II (delayed/no LCT)

ACTIVE COMPARATOR

Patients undergo standard maintenance therapy or clinical observation, based on physician choice. Patients may cross-over to Arm I due to RECIST progression or toxicity at the treating physician's discretion.

Other: Clinical Observation; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Procedure: Standard Follow-Up Care

Interventions

Clinical Observation OTHER

Undergo clinical observation

Also known as: observation

Arm II (delayed/no LCT)

External Beam Radiation Therapy RADIATION

Undergo EBRT

Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiotherapy, External Beam RT, external radiation, External Radiation Therapy, external-beam radiation

Arm I (immediate LCT)

Laboratory Biomarker Analysis OTHER

Optional correlative studies

Arm I (immediate LCT); Arm II (delayed/no LCT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (immediate LCT); Arm II (delayed/no LCT)

Standard Follow-Up Care PROCEDURE

Undergo standard maintenance therapy

Arm II (delayed/no LCT)

Therapeutic Conventional Surgery PROCEDURE

Undergo surgery

Arm I (immediate LCT)

Eligibility Criteria

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

You may qualify if:

• STEP 1 ENROLLMENT: the patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration; mixed tumors will be categorized by the predominant cell type
• STEP 1 ENROLLMENT: the patient has a diagnosis of American Joint Committee on Cancer (AJCC) 7th Edition stage IV NSCLC
• STEP 1 ENROLLMENT: three or less metastatic lesions (not sites); each lesion (including a satellite nodule) will individually be counted as one, and intrathoracic lymph node involvement (defined here as hilar, mediastinal, or supraclavicular nodes, N1-N3) will collectively be counted as one; in addition, patients can receive treatment to CNS lesions or other symptomatic lesions requiring urgent local therapy prior to randomization, but these lesions will be counted towards the total number after chemotherapy, and patients will only be eligible if there are remaining sites amenable to local therapy after up-front systemic therapy
• STEP 1 ENROLLMENT: standard induction chemotherapy planned defined as: at least 4 cycles of platinum doublet chemotherapy for metastatic disease (with or without bevacizumab); if the patient is known to be EGFR mutation positive, erlotinib, afatinib, or gefitinib for \>= 3 months, or for patients with known EML4-ALK fusions, crizotinib for \>= 3 months
• STEP 2 ENROLLMENT AND RANDOMIZATION: the patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration; mixed tumors will be categorized by the predominant cell type
• STEP 2 ENROLLMENT AND RANDOMIZATION: the patient has a diagnosis of American Joint Committee on Cancer (AJCC) 7th edition stage IV NSCLC
• STEP 2 ENROLLMENT AND RANDOMIZATION: completion of standard induction chemotherapy planned defined as: at least 4 cycles of platinum doublet chemotherapy for metastatic disease (with or without bevacizumab); if the patient is known to be EGFR mutation positive, erlotinib, afatinib, or gefitinib for \>= 3 months, or for patients with known EML4-ALK fusions, crizotinib; note that it is not mandatory to check EGFR mutation or EML4-ALK status prior to entry, but patients that receive options 2 or 3 should have had these molecular tests performed
• STEP 2 ENROLLMENT AND RANDOMIZATION: less than or equal to three metastatic lesions and no evidence of disease progression based on RECIST criteria; note that patients that had \> 3 metastatic lesions in Step 1 may be eligible for enrollment in Step 2 if the number of metastatic sites is reduced to three or less
• STEP 2 ENROLLMENT AND RANDOMIZATION: the patient's Eastern Cooperative Oncology Group (ECOG) performance status is =\< 2 at study entry
• STEP 2 ENROLLMENT AND RANDOMIZATION: absolute neutrophil count (ANC) \>= 1,500/mm\^3 within 3 weeks of study entry
• STEP 2 ENROLLMENT AND RANDOMIZATION: platelet count \>= 100,000/mm\^3 within 3 weeks of study entry
• STEP 2 ENROLLMENT AND RANDOMIZATION: white blood cells (WBC) \>= 3,000/mm\^3 within 3 weeks of study entry
• STEP 2 ENROLLMENT AND RANDOMIZATION: hemoglobin \>= 9 g/dL within 3 weeks of study entry
• STEP 2 ENROLLMENT AND RANDOMIZATION: the patient must be a suitable candidate for LCT (radiotherapy and/or surgery) to every site of disease, as determined by the treating physician(s); consultation with a multidisciplinary team, including a medical oncologist, radiation oncologist, and thoracic surgeon, is encouraged but not required
• STEP 2 ENROLLMENT AND RANDOMIZATION: concurrent chemoradiation is permitted as consolidative therapy; the following concurrent therapies are permitted: tyrosine kinase inhibitors (i.e. erlotinib) - can be delivered with both hypofractionated (\>= 3 Gray \[Gy\] per fraction) and standard fractionated radiation therapy (\< 3 Gy per fraction); platinum-based chemotherapy - standard fractionated radiation therapy (\< 3 Gy per fraction)

You may not qualify if:

• STEPS 1 AND 2 AND RANDOMIZATION
• The patient has a history of uncontrolled angina, arrhythmias, or congestive heart failure
• Patients with a history of malignant pleural effusions are not eligible; pleural effusions considered by the investigator too small for a diagnostic thoracentesis are permissible
• Patient is pregnant (confirmed by serum beta- b-human chorionic gonadotropin \[HCG\] if applicable) or is breastfeeding
• Presence of significant third space fluid which cannot be controlled by drainage

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of Colorado

Denver, Colorado, 80217-3364, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

London Health Sciences Centre-South Street

London, Ontario, N6A 4G5, Canada

Location

Related Publications (2)

• Tang C, Lee WC, Reuben A, Chang L, Tran H, Little L, Gumbs C, Wargo J, Futreal A, Liao Z, Xia X, Yi X, Swisher SG, Heymach JV, Gomez D, Zhang J. Immune and Circulating Tumor DNA Profiling After Radiation Treatment for Oligometastatic Non-Small Cell Lung Cancer: Translational Correlatives from a Mature Randomized Phase II Trial. Int J Radiat Oncol Biol Phys. 2020 Feb 1;106(2):349-357. doi: 10.1016/j.ijrobp.2019.10.038. Epub 2019 Oct 31.

  PMID: 31678224 DERIVED

• Gomez DR, Blumenschein GR Jr, Lee JJ, Hernandez M, Ye R, Camidge DR, Doebele RC, Skoulidis F, Gaspar LE, Gibbons DL, Karam JA, Kavanagh BD, Tang C, Komaki R, Louie AV, Palma DA, Tsao AS, Sepesi B, William WN, Zhang J, Shi Q, Wang XS, Swisher SG, Heymach JV. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: a multicentre, randomised, controlled, phase 2 study. Lancet Oncol. 2016 Dec;17(12):1672-1682. doi: 10.1016/S1470-2045(16)30532-0. Epub 2016 Oct 24.

  PMID: 27789196 DERIVED

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Watchful Waiting; Observation

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)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Methods; Investigative Techniques

Results Point of Contact

• Title: Dr, Chad Tang
• Organization: M D Anderson Cancer Center

ctang1@mdanderson.org

(713) 745-7179

Study Officials

• Chad Tang

  M.D. Anderson Cancer Center

  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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 12, 2012
• Study Start: November 28, 2012
• Primary Completion: May 8, 2024
• Study Completion: May 8, 2024
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2024-10

Locations

CA (1); US (2)