Clinical trial NCT02889666: A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Recurrent Non-small Cell Lung Cancer
Keywords: relapsed
non-small cell lung cancer
cisplatin
carboplatin
oxaliplatin
docetaxel
gemcitabine
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai 10th People's Hospital
name: Jilin University
name: Jiangxi Provincial Cancer Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
First posted: 2016-09-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the commonly administered chemotherapeutic agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid tumors in clinical oncology, either a single format or given as combinations followed by surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer patients.

Detailed description: Lung carcinoma is a malignant disease characterized by uncontrolled alveolar type II epithelial cell growth in lung tissues. Worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths, making it the most common cause of cancer-related death in men and second most common in women after breast cancer. The most common age at diagnosis is 70 years, and less than 20% of people diagnosed with lung cancer can survive five years post diagnosis. The two main types of lung carcinomas are small cell lung carcinoma (SCLC) and non-small cell lung carcinoma (NSCLC). NSCLC represents the most common type of lung cancers, and approximately 85% of lung cancers are NSCLC. Squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of NSCLC, the latter associated with high mortality in overall cancer populations with limited treatment options.

In this study, the investigators performed a Phase I, open label, agent-combination exploration, multicenter clinical trial to establish the treatment efficacy of several chemotherapeutic agents in patients with recurrent NSCLC who have undergone prior surgery for the primary disease. Up to four cohorts have been enrolled to determine the effectiveness and safety of single or combinational therapeutic strategy. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also take into account the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to support the treatment efficacy and assess the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.

Eligibility 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

Primary outcomes:
measure: 5 years disease-free survival
timeFrame: 5 years
Secondary outcomes:
measure: 5 years overall survival
timeFrame: 5 years
measure: 5 years metastasis-free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Changchun
country: China
facility: China-Japan Union Hospital, Jilin University
state: Jilin
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital, Tongji University School of Medicine
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Yu Sun, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: