Clinical trial · Interventional
Study of Radiotherapy Combined With Albumin Bound Paclitaxel and Nedaplatin for Locally Advanced NSCLC
A Phase II,Randomized Controlled Clinical Trial of Staged Thoracic Radiotherapy Combined With Albumin Bound Paclitaxel and Nedaplatin Twice a Week for Locally Advanced NSCLC
NCT04524299CI-TRIAL-00046772unknownPhase 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)
This phase II randomized study is to investigate the efficacy and toxicity of fractional thoracic radiotherapy combined with albumin bound paclitaxel and nedaplatin twice a week in the treatment of locally advanced non-small cell lung cancer compared with weekly chemotherapy.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chest radiation(IMRT) | Radiation | — | UNRESOLVED |
| Concurrent chemotherapy once a week | Drug | — | UNRESOLVED |
| Concurrent chemotherapy twice a week | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Concurrent chemotherapy Twice a Week
- description
- During the period of radiotherapy, 30 mg / m2 albumin bound paclitaxel was intravenously infused twice a week for 0.5 hours, and nedaplatin 10 mg / m2 twice a week for 0.5 hours.
- interventionNames
- Radiation: chest radiation(IMRT)
- Drug: Concurrent chemotherapy twice a week
- type
- ACTIVE_COMPARATOR
- label
- Concurrent chemotherapy Once a Week
- description
- During the same period of radiotherapy, albumin bound paclitaxel (50 mg / m2) was intravenously infused once a week for 0.5 hours; nedaplatin (25 mg / m2) was intravenously infused once a week for 0.5 hours.
- interventionNames
- Radiation: chest radiation(IMRT)
- Drug: Concurrent chemotherapy once a week
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed non-small cell lung cancer. * There were measurable diseases according to recist1.1. * Non operative stage III (AJCC / UICC eighth edition stage). * When the lowest dose of radiotherapy was 60Gy, V20 \> = 35% in both lungs. * 18 years old or above, under 75 years old, regardless of gender. * ECoG physical status score (see Annex 1) was 0-1. * Initial treatment or chemotherapy. * There was no previous chest radiotherapy, immunotherapy or biotherapy. * Neutrophil absolute value ≥ 2000 cells / mm3, platelet ≥ 100000 cells / mm3 * Serum creatinine ≤ 1.25 times ULN or creatinine clearance rate ≥ 60 ml / min. * Serum bilirubin ≤ 1.5 times ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN, alkaline phosphatase ≤ 5 times ULN. * CB6 normal range. * The patient and his family members agreed and signed the informed consent. Exclusion Criteria: * There were other malignant tumors in the past or during treatment, except for skin non melanoma or cervical carcinoma in situ. * Any other disease or condition is contraindication to chemotherapy (e.g. active infection, within 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy). * Pregnant or lactating women, women who did not undergo a pregnancy test (within 14 days before the first administration), and pregnant women. * Bleeding tendency. * Participants in other clinical trials within 30 days before the experiment. * Drug addiction, long-term alcoholism and AIDS patients. * There are uncontrollable seizures or loss of self-control due to mental illness. * Patients with severe allergic history or specific constitution. * The researchers consider that it is not suitable to participate in this experiment.
References
Publications (29)
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- BACKGROUNDDillman RO, Seagren SL, Propert KJ, Guerra J, Eaton WL, Perry MC, Carey RW, Frei EF 3rd, Green MR. A randomized trial of induction chemotherapy plus high-dose radiation versus radiation alone in stage III non-small-cell lung cancer. N Engl J Med. 1990 Oct 4;323(14):940-5. doi: 10.1056/NEJM199010043231403. PMID 2169587
- BACKGROUNDSause W, Kolesar P, Taylor S IV, Johnson D, Livingston R, Komaki R, Emami B, Curran W Jr, Byhardt R, Dar AR, Turrisi A 3rd. Final results of phase III trial in regionally advanced unresectable non-small cell lung cancer: Radiation Therapy Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group. Chest. 2000 Feb;117(2):358-64. doi: 10.1378/chest.117.2.358. PMID 10669675
- BACKGROUNDFuruse 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. PMID 10561343
- 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
- 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.