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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02874 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2012-0618 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
PRIMARY OBJECTIVES:
I. Determine whether oligometastatic non-small cell lung cancer (NSCLC) patients with no disease progression after first line therapy have prolonged progression free survival (PFS) when treated with local consolidation therapy (LCT) of residual disease (radiation or surgery) followed by maintenance or surveillance as per physician choice compared with no LCT.
SECONDARY OBJECTIVES:
I. Determine the overall survival. II. Safety/tolerability of LCT. III. Time to progression of prior metastatic lesions. IV. Time to appearance of new metastases (central nervous system [CNS] vs. extra-CNS, treated lesion vs. new site).
V. Quality of life (QOL).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (IMMEDIATE LCT): Patients undergo ablation of all residual local and metastatic sites of disease by surgery and/or external beam radiation therapy (EBRT). After completion of LCT, patients undergo either surveillance or maintenance treatment at the discretion of the treating physician.
ARM II (DELAYED/NO LCT): Patients undergo standard maintenance therapy or clinical observation, based on physician choice. Patients may cross-over to Arm I due to Response Evaluation Criteria in Solid Tumors (RECIST) progression or toxicity at the treating physician's discretion.
After completion of study treatment, patients are followed up for 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Observation | Other | Undergo clinical observation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to New Lesion Progression | The measurement of time to new lesion progression of patients from the start of trial participation until the time their disease progresses. 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. | 5.7 to 24.3 months (LCT group); 4.4 to 8.3 months (MT/O group) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad Tang | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Denver | Colorado | 80217-3364 | United States | ||
| M D Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31678224 | Derived | 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. | |
| 27789196 |
| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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Three patients in the MT/O arm who crossed over to receive LCT before progression were excluded because they did not adhere to either arm of the study.
Dates of recruitment period: 11/28/2012 to 02/01/2016 ; Location: Multi-center trial that recruited patients at three different hospital sites (MD Anderson Cancer Center, Houston, TX; London Health Sciences Center, London, Ontario; and The University of Colorado, Aurora, CO) 9 patients in the MT/O group received LCT after progression. The remaining 15 did not.
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| ID | Title | Description |
|---|---|---|
| FG000 | LCT Arm | LCT with radiation therapy or surgery followed by standard maintenance or observation |
| FG001 | MT/O Arm | Standard maintenance (chosen by the treating physician from predefined set of standard of care options) or observation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2024 |
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| External Beam Radiation Therapy | Radiation | Undergo EBRT |
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| Laboratory Biomarker Analysis | Other | Optional correlative studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Standard Follow-Up Care | Procedure | Undergo standard maintenance therapy |
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| Therapeutic Conventional Surgery | Procedure | Undergo surgery |
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| Houston |
| Texas |
| 77030 |
| United States |
| London Health Sciences Centre-South Street | London | Ontario | N6A 4G5 | Canada |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LCT Arm | LCT with radiation therapy or surgery followed by standard maintenance or observation |
| BG001 | MT/O Arm | Standard maintenance (chosen by the treating physician from predefined set of standard of care options) or observation |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Patient Characteristics | Age (years), Sex, Ethnicity, Tumor histology, Timing of metastatic disease, Number of of nonregional metastases after initial systemic therapy, Response to first-line chemotherapy, CNS metastases, Nodal status, Mutation type | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | 95% Confidence Interval | Months | 16.6 months to 41.2 months for all patients in both LCT and MT/O group |
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| Secondary | Time to New Lesion Progression | The measurement of time to new lesion progression of patients from the start of trial participation until the time their disease progresses. 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. | Posted | Median | Full Range | Months | 5.7 to 24.3 months (LCT group); 4.4 to 8.3 months (MT/O group) |
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From baseline to 61.4 months post treatment.
At the time of cross over they came off active study follow up. No adverse events were assessed after cross over.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LCT Arm | LCT with radiation therapy or surgery followed by standard maintenance or observation | 11 | 25 | 0 | 25 | 14 | 25 |
| EG001 | MT/O Arm | Standard maintenance (chosen by the treating physician from predefined set of standard of care options) or observation | 18 | 24 | 0 | 24 | 12 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Renal Insufficiency | Renal and urinary disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Esophagitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Odynophagia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Peripheral Sensory Neuropathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neuropathy | Nervous system disorders | Systematic Assessment |
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| Peripheral Neuropathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dysphagia | General disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Hoarseness | General disorders | Systematic Assessment |
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| Pain (of neck) | General disorders | Systematic Assessment |
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| Pain (of chestwall) | General disorders | Systematic Assessment |
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| Watery eyes | General disorders | Systematic Assessment |
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| Back Pain | General disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Short of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
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| Chronic Renal Failure | Renal and urinary disorders | Systematic Assessment |
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| Blurred Vision | General disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Thrombophlebitis | Vascular disorders | Systematic Assessment |
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| Depression | General disorders | Systematic Assessment |
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| Anion Gap Decrease | Blood and lymphatic system disorders | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Left rib pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cellulitis | General disorders | Systematic Assessment |
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| Thrush | Infections and infestations | Systematic Assessment |
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| Abdominal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Anorexia | General disorders | Systematic Assessment |
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| Edema | Blood and lymphatic system disorders | Systematic Assessment |
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| Dry Eyes | General disorders | Systematic Assessment |
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| Hypoxemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Hyperkalemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Mucositis Oral | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Urinary difficulties | Renal and urinary disorders | Systematic Assessment |
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| Weight loss | General disorders | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Cough | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr, Chad Tang | M D Anderson Cancer Center | (713) 745-7179 | ctang1@mdanderson.org |
| May 28, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| D019370 | Observation |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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