Clinical trial · Interventional
Hypofractionated Radiation Therapy Combined With Concurrent Chemotherapy for Patients With Non-small Cell Lung Cancer
A Phase II Study of Accelerated Hypofractionated Three-dimensional Conformal Radiation Therapy Concurrent With Chemotherapy in Unresectable Stage III Non-small Cell Lung Cancer
NCT02720614CI-TRIAL-00021516completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety of accelerated hypofractionated three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent with chemotherapy for patients with unresectable stage III non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated radiation/chemotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated radiation/chemotherapy
- description
- Hypofractionated radiation：Patients receive accelerated hypofractionated radiation: three-dimensional conformal radiation therapy (3-DCRT) with a total dose of 69 Gy, delivered at 3 Gy per fraction, once daily, five fractions per week, completed within 4.6 weeks. Chemotherapy: Regimen 1 is as follows: vinorelbine (NVB) was administered by intravenous infusion at a dose of 25 mg/m2 on day 1 (d1) and day 8 (d8), and carboplatin (CBP) is administered at a concentration-time curve (AUC) of 5 mg/ml on d8. This treatment was repeated every 28 days. One cycle of chemotherapy is performed concurrently with the radiotherapy. Chemotherapy: Regimen 2 is as follows: paclitaxel at 30 mg/m2 and cisplatin at 20 mg/m2 (TP) are administrated every week for 5 weeks continuously.
- interventionNames
- Radiation: Hypofractionated radiation/chemotherapy
Primary outcomes (1)
- measure
- Number of Participants with Severe and Life-threatening Adverse Events (AE)
- timeFrame
- Baseline to the time of intolerable toxicity(up to 1 year) or measured Progressive Disease (PD)
- description
- intolerable toxicities: severe and life-threatening adverse events (Grade III/IV in Common Terminology Criteria for Adverse Events v3.0 (CTCAE 3.0))
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathological or cytological diagnose of unresectable stage III non-small cell lung cancer * The Karnofsky performance status (KPS) score ≥70. * The expected survival time ≥3 months. * Adequate blood, liver, lungs and kidney function * Accessible contact information * Informed consent required before enrollment. Exclusion Criteria: * Pregnant or breastfeeding. * Another malignant tumor history (with the exception of patients with cervical carcinoma in situ and non-malignant melanoma skin cancer that had been clinically cured for at least 5 years) * Cannot receive concurrent chemotherapy due to medical reasons. * Superior vena cava syndrome. * Severe lung diseases that affected lung function.
References
Publications (24)
- BACKGROUNDFerlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516. PMID 21351269
- BACKGROUNDChen W, Zheng R, Zhang S, Zhao P, Zeng H, Zou X. Report of cancer incidence and mortality in China, 2010. Ann Transl Med. 2014 Jul;2(7):61. doi: 10.3978/j.issn.2305-5839.2014.04.05. PMID 25333036
- BACKGROUNDBayman N, Blackhall F, McCloskey P, Taylor P, Faivre-Finn C. How can we optimise concurrent chemoradiotherapy for inoperable stage III non-small cell lung cancer? Lung Cancer. 2014 Feb;83(2):117-25. doi: 10.1016/j.lungcan.2013.11.017. Epub 2013 Dec 1. PMID 24373738
- BACKGROUNDAuperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29. PMID 20351327
- BACKGROUNDKong 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. PMID 16168827
- BACKGROUNDLin Q, Liu YE, Ren XC, Wang N, Chen XJ, Wang DY, Zong J, Peng Y, Guo ZJ, Hu J. Dose escalation of accelerated hypofractionated three-dimensional conformal radiotherapy (at 3 Gy/fraction) with concurrent vinorelbine and carboplatin chemotherapy in unresectable stage III non-small-cell lung cancer: a phase I trial. Radiat Oncol. 2013 Aug 17;8(1):201. doi: 10.1186/1748-717X-8-201.