Thoracic Re-irradiation For Locoregionally Recurrent Non-small Cell Lung Cancer
NCT ID: NCT04275687
Last Updated: 2020-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
35 participants
INTERVENTIONAL
2020-03-01
2025-02-01
Brief Summary
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Detailed Description
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1. For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.
2. For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4\~7 daily fractions as a boost. Concurrent chemotherapy consists of weekly docetaxel and nedaplatin.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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thoracic irradiation
For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.
For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4\~7 daily fractions as a boost. Concurrent chemotherapy consists of weekly docetaxel and nedaplatin.
thoracic irradiation
For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.
For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4\~7 daily fractions as a boost.
Concurrent chemotherapy
For centrally located recurrent tumors, concurrent chemotherapy consists of weekly docetaxel and nedaplatin.
Interventions
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thoracic irradiation
For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.
For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4\~7 daily fractions as a boost.
Concurrent chemotherapy
For centrally located recurrent tumors, concurrent chemotherapy consists of weekly docetaxel and nedaplatin.
Eligibility Criteria
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Inclusion Criteria
* chemotherapy, targeted or immunotherapy are allowed before enrollment;
* \>=6 months from previous chest radiotherapy;
* presence of measurable disease according to RECIST criteria;
* ECOG performance score is 0-1;
* organ and bone marrow functions meet the following criteria:
* forced expiratory volume in 1 second (FEV1) ≥ 0.8L;
* percentage-predicted single-breath carbon monoxide diffusing capacity (DLCO %) \> 60%;
* absolute neutrophil count ≥1.5×10\^9/L;
* platelet ≥80×10\^9/L;
* hemoglobin ≥9.0g/dL;
* serum creatinine clearance was ≥50 mL/min calculated based on the Cockcroft-Gault formula
* serum bilirubin ≤1.5 times normal upper limit (ULN)
* AST and ALT≤2.5 times ULN
Exclusion Criteria
* loco-regional recurrence with distant metastasis;
* any other disease or condition contradicted to radiotherapy (e.g., active infection, within 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
* women who are pregnant or breastfeeding, women who have not undergone a pregnancy test (within 14 days before first administration), and women who are pregnant;
* pregnancy, lactation, or fertility but no contraceptive measures;
* those with bleeding tendency;
* participate in other clinical trials within 30 days before enrollment;
* drug and other drug addiction, chronic alcoholism and AIDS patients;
* having uncontrollable seizures or loss of self-control due to psychosis;
* a history of severe allergies;
* participants considered unfit to participate in this study.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Hui Liu
Professor
Principal Investigators
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Hui Liu, Prof.
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University
Guangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Milton DT, Miller VA. Advances in cytotoxic chemotherapy for the treatment of metastatic or recurrent non-small cell lung cancer. Semin Oncol. 2005 Jun;32(3):299-314. doi: 10.1053/j.seminoncol.2005.02.011.
Noble J, Ellis PM, Mackay JA, Evans WK; Lung Cancer Disease Site Group of Cancer Care Ontario's Program in Evidence-based Care. Second-line or subsequent systemic therapy for recurrent or progressive non-small cell lung cancer: a systematic review and practice guideline. J Thorac Oncol. 2006 Nov;1(9):1042-58.
Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. doi: 10.1056/NEJMoa1606774. Epub 2016 Oct 8.
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Kong FM, Ten Haken RK, Schipper MJ, Sullivan MA, Chen M, Lopez C, Kalemkerian GP, Hayman JA. High-dose radiation improved local tumor control and overall survival in patients with inoperable/unresectable non-small-cell lung cancer: long-term results of a radiation dose escalation study. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):324-33. doi: 10.1016/j.ijrobp.2005.02.010.
Schild SE, McGinnis WL, Graham D, Hillman S, Fitch TR, Northfelt D, Garces YI, Shahidi H, Tschetter LK, Schaefer PL, Adjei A, Jett J. Results of a Phase I trial of concurrent chemotherapy and escalating doses of radiation for unresectable non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1106-11. doi: 10.1016/j.ijrobp.2006.02.046. Epub 2006 May 26.
Reyngold M, Wu AJ, McLane A, Zhang Z, Hsu M, Stein NF, Zhou Y, Ho AY, Rosenzweig KE, Yorke ED, Rimner A. Toxicity and outcomes of thoracic re-irradiation using stereotactic body radiation therapy (SBRT). Radiat Oncol. 2013 Apr 25;8:99. doi: 10.1186/1748-717X-8-99.
Spoelstra FO, Pantarotto JR, van Sornsen de Koste JR, Slotman BJ, Senan S. Role of adaptive radiotherapy during concomitant chemoradiotherapy for lung cancer: analysis of data from a prospective clinical trial. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1092-7. doi: 10.1016/j.ijrobp.2008.12.027. Epub 2009 Mar 26.
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Furuse K, Fukuoka M, Kawahara M, Nishikawa H, Takada Y, Kudoh S, Katagami N, Ariyoshi Y. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol. 1999 Sep;17(9):2692-9. doi: 10.1200/JCO.1999.17.9.2692.
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Other Identifiers
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GASTO1057
Identifier Type: -
Identifier Source: org_study_id
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