A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer

Phase 1

Recruiting

• Conditions: Recurrent Non-small Cell Lung Cancer
• Interventions: Drug: Docetaxel; Drug: Gemcitabine/Cisplatin; Drug: Docetaxel/Oxaliplatin; Drug: Docetaxel/Carboplatin; Drug: Gemcitabine/Carboplatin; Drug: Placebo; Drug: Carboplatin; Drug: Cisplatin

• Registration Number: NCT02889666
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-09-02
• Study First Posted: 2016-09-05
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

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Exclusion Criteria

• Age ≥ 76
• Severe major organ dysfunction
• WHO performance status of >1
• Prior cancer chemotherapy
• Stage IV

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docetaxel	Docetaxel	Docetaxel-based chemotherapy (Docetaxel 120mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Docetaxel was done for 3 cycles with 30 days after last surgery.
Gemcitabine/Cisplatin	Gemcitabine/Cisplatin	Gemcitabine/Cisplatin-based combinational chemotherapy (Gemcitabine 200mg + Cisplatin 60mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery.
Docetaxel/Oxaliplatin	Docetaxel/Oxaliplatin	Docetaxel/Oxaliplatin-based chemotherapy (Docetaxel 120mg + Oxaliplatin 200mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery.
Docetaxel/Carboplatin	Docetaxel/Carboplatin	Docetaxel/Carboplatin-based chemotherapy (Docetaxel 120mg + Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery.
Gemcitabine/Carboplatin	Gemcitabine/Carboplatin	Gemcitabine/Carboplatin-based chemotherapy (Gemcitabine 200mg + Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery.
Placebo	Placebo	No Adjuvant chemotherapy using CCODG was done for patients who had previous surgery to remove the primary non-small cell lung carcinoma but subject to tumor relapse. Instead, placebo was supplied to these patients as a comparator Arm.
Carboplatin	Carboplatin	Carboplatin-based chemotherapy (Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Carboplatin was done for 3 cycles with 30 days after last surgery.
Cisplatin	Cisplatin	Cisplatin-based chemotherapy (Cisplatin 60mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Cisplatin was done for 3 cycles with 30 days after last surgery.

Primary Outcome Measures

Name	Time	Method
5 years disease-free survival	5 years	The disease-associated survival status during the 5 years post treatment will be measured. Note the information in the Outcome Measure is only study hypothesis.

Secondary Outcome Measures

Name	Time	Method
5 years overall survival	5 years	The overall survival status during the 5 years post treatment will be measured. Information in the Outcome Measure is only study hypothesis.
5 years metastasis-free survival	5 years	The metastasis-associated survival status during the 5 years post treatment will be measured. Information in the Outcome Measure is only study hypothesis.

Trial Locations

Locations (3)

China-Japan Union Hospital, Jilin University; 🇨🇳 Changchun, Jilin, China

Shanghai Pulmonary Hospital, Tongji University School of Medicine; 🇨🇳 Shanghai, China

Shanghai 10th People's Hospital; 🇨🇳 Shanghai, China