Chemotherapy combined with surgery for recurrent non-small cell lung cancer
A Multi-Center and Randomized Control Trial of Cisplatin, Carboplatin, Oxaliplatin, Docetaxel and Gemcitabine Plus Surgery as Treatment for Relapsed and Refractory Non-Small Cell Lung Cancer
PHASE1 · Shanghai Jiao Tong University School of Medicine · NCT02889666
This study is testing different chemotherapy drugs combined with surgery to see if they can help people with recurrent non-small cell lung cancer live longer and feel better after their initial treatment.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine (other) |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Changchun, Jilin and 2 other locations) |
| Trial ID | NCT02889666 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of various chemotherapeutic agents, including cisplatin, carboplatin, docetaxel, and gemcitabine, in patients with recurrent non-small cell lung cancer (NSCLC) who have previously undergone surgery. It is a Phase I, open-label, multicenter trial that explores both single-agent and combination therapies to determine their safety and efficacy. The study will assess outcomes such as overall survival, disease-free survival, and metastasis-free survival over a five-year period. The trial includes multiple cohorts to better understand the potential benefits of these treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 75 or younger with histologically confirmed NSCLC and no severe organ dysfunction.
Not a fit: Patients aged 76 or older, those with severe organ dysfunction, or those who have received prior chemotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with recurrent non-small cell lung cancer.
How similar studies have performed: Other studies have shown promise with similar chemotherapy approaches in treating NSCLC, but this specific combination and methodology is being explored in a novel context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≤ 75 years with histologically proven NSCLC * No severe major organ dysfunction * WHO performance status of 0 or 1 * No prior cancer chemotherapy * A Clinical Stage ≥ IA (T1a, N0, M0) of lung disease but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included a pleural computed tomography (CT) scan. Exclusion Criteria: * Age ≥ 76 * Severe major organ dysfunction * WHO performance status of \>1 * Prior cancer chemotherapy * Stage IV
Where this trial is running
Changchun, Jilin and 2 other locations
- China-Japan Union Hospital, Jilin University — Changchun, Jilin, China (RECRUITING)
- Shanghai 10th People's Hospital — Shanghai, China (RECRUITING)
- Shanghai Pulmonary Hospital, Tongji University School of Medicine — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Yu Sun, Ph.D — Shanghai Jiao Tong University School of Medicine
- Study coordinator: Yu Sun, Ph.D
- Email: sunyu@sibs.ac.cn
- Phone: 86-21-54923302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Recurrent Non-small Cell Lung Cancer, relapsed, non-small cell lung cancer, cisplatin, carboplatin, oxaliplatin, docetaxel, gemcitabine