Thoracic Re-irradiation For Locoregionally Recurrent Non-small Cell Lung Cancer

This prospective phase II study is to assess the efficacy and safety of thoracic re-irradiation for locoregionally recurrent non-small cell lung cancer using hypofractionated technique.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

* loco-regionally recurrent NSCLC after thoracic radiotherapy (confirmed by pathology or continuous enhanced CT imaging);
* 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:

* previous or concurrent with other malignant tumors, except for non-melanoma of the skin or carcinoma in situ of the cervix;
* 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.

• BACKGROUNDJemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. PMID 21296855
• BACKGROUNDPfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR; American Society of Clinical Oncology. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol. 2004 Jan 15;22(2):330-53. doi: 10.1200/JCO.2004.09.053. Epub 2003 Dec 22. No abstract available. PMID 14691125
• BACKGROUNDGoldstraw P, Chansky K, Crowley J, Rami-Porta R, Asamura H, Eberhardt WE, Nicholson AG, Groome P, Mitchell A, Bolejack V; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee Advisory Boards and Participating Institutions. The IASLC Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groupings in the Forthcoming (Eighth) Edition of the TNM Classification for Lung Cancer. J Thorac Oncol. 2016 Jan;11(1):39-51. doi: 10.1016/j.jtho.2015.09.009. PMID 26762738
• BACKGROUNDCurran WJ Jr, Paulus R, Langer CJ, Komaki R, Lee JS, Hauser S, Movsas B, Wasserman T, Rosenthal SA, Gore E, Machtay M, Sause W, Cox JD. Sequential vs. concurrent chemoradiation for stage III non-small cell lung cancer: randomized phase III trial RTOG 9410. J Natl Cancer Inst. 2011 Oct 5;103(19):1452-60. doi: 10.1093/jnci/djr325. Epub 2011 Sep 8. PMID 21903745
• BACKGROUNDMilton 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. PMID 15988685
• BACKGROUNDNoble 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.