Clinical Trials in Lung Cancer Surgery, Research Cooperation
The number of lung cancer patients in China is increasingly accelerating by up to 500,000 annually, which should be blamed on the largest quantities of tobacco products and smokers. So China would play a leading role in fields of lung cancer researches as long as with effective combinations of sponsorship from pharmaceutical manufacturers, experienced researchers and abundant resources of patients. From 2001–2006, several small-scale multicenter RCT for adjuvant and neo-adjuvant therapy were established by the organization of Chinese society of lung cancer. Meanwhile, with arrival of a new epoch based on individual targeted therapy, lung cancer researchers in China began to participate in the most important international clinical trials, such as INTETEST, IPASS, FASTACT, JMEN, TRUST, and so on, have access to professional training, contribute a large amount of lung cancer cases, and make Chinese voice heard. In 2007, based on international trial experiences, a national collaborative clinical research group, CTONG, was established. CTONG is a large network of researchers, surgeons, medical oncologists, radiation oncologists, statisticians, nurses/clinical research associates, health-care professionals and patient advocates at public institutions throughout China. Up to now, there have already been 25 top member hospitals. The purpose of this collaborative group is to carry out multi-center clinical trials for lung cancer, and provide high level of evidence-based medicine for clinical practices and translational researches. CTONG, an extremely active and well-organized study group, takes responsibility of carrying out phase I-IV clinical trials and translational research, establishing database of lung cancer patients and tissue bank, and promoting professional trainings as well as international communications. More than 10,000 new cases of lung cancer have been diagnosed and treated in CTONG hospitals every year, thus enabling China to initiate bio-marker driven trials rapidly. CTONG have already published major studies such as OPTIMAL, INFORM and FASTACT 2 just within a few years since establishment, contributing substantially to lung cancer patients and being expected to obtain more triumphs.
Apart from trials for advanced NSCLC, series of peri-operative trials about adjuvant and neoadjuvant chemotherapy/EGFR-tyrosine kinase inhibitor (EGFR-TKI) are being conducted by CTONG (Figure 2). Adjuvant cisplatin-based chemotherapy is recommended for routine use in patients with Stage IIA, IIB, and IIIA NSCLCs after complete resection and thus cisplatin and vinorelbine combination act as standard therapy. In addition, activating somatic mutations of tyrosine kinase domains of EGFR have been characterized in a subset of patients with advanced NSCLC. The EGFR mutation rate was 40–50% in Asia NSCLC population. Patients harboring these mutations show excellent response to EGFR-TKIs. In Sep 2011, investigator-initiated multicenter randomized phase III clinical trial in China (Adjuvant, CTONG 1104) initiated adjuvant gefitinib studies in EGFR mutant NSCLC, when Japan (IMPACT; WJOG6401L) has a similar design at the same time. A total number of 220–230 completely resected IIIA-II/N2-N1 NSCLC patients with EGFR mutation would be randomized (1:1) into gefitinib versus combination of vinorelbine plus platinum group as adjuvant treatment. The primary endpoint is DFS. Despite of competition about patients enrolling between Japan and China, the final data will be independently published but pooled in collaboration. At the beginning stage of CTONG 1104, the enrollment was slow due to single origin of candidates. Following with researcher conferences, further coordination and communications between PIs, and promotion of multi-center, enrollment began to accelerate apparently from Sep 2012 and has finished enrollment now (Figures 3,4).
(Enlarge Image)
Figure 2.
CTONG trials—establish lung cancer treatment modalities of China and East Asians style. CTONG, Chinese Thoracic Oncology Group.
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Figure 3.
CTONG 1104 (adjuvant). CTONG, Chinese Thoracic Oncology Group.
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Figure 4.
Enrollment of CTONG 1104 (adjuvant). CTONG, Chinese Thoracic Oncology Group.
It is imperative to unite regulatory authorities, clinical trial sponsors, collaborative research groups, research nurses, study coordinators and data managers together to expedite study approval for clinical trials. There are several time internals act as bottlenecks which restrict progressions of trials to a large extent, such as regulatory approval, ethics approval, protocol amendments, time for patient enrollment, just name a few. When designing trial protocols, researchers have compared between different clinical trials, like ACOSOG-Z0030, LCSG 821, JCOG 0802, CALGB 140503, CALGB 39802, CHEST, NATCH, CSLC 0501, CTONG 1103 and CTONG 1104 on respects of collaborative research groups, financial support, collection of current evidence, trial design and planning, regulatory affairs, trial period activities, follow-up and data management. These trials have demonstrated surgeons' ability to acquire fresh tissues when operating for central specimen bank storage. Surgeons have taken on the complex task of obtaining patients' written informed consents for tissue acquisition and laboratory investigations. These trials enable patients to obtain easier access to innovative therapies and enhance the efficiency and quality of clinical researches, thus requiring surgeons taking more responsibility to successfully accrue patients with early-stage diseases. Effective cooperative group system would throw highlight on the promising future of thoracic malignancy therapy.
Chinese Thoracic Oncology Group (CTONG)
The number of lung cancer patients in China is increasingly accelerating by up to 500,000 annually, which should be blamed on the largest quantities of tobacco products and smokers. So China would play a leading role in fields of lung cancer researches as long as with effective combinations of sponsorship from pharmaceutical manufacturers, experienced researchers and abundant resources of patients. From 2001–2006, several small-scale multicenter RCT for adjuvant and neo-adjuvant therapy were established by the organization of Chinese society of lung cancer. Meanwhile, with arrival of a new epoch based on individual targeted therapy, lung cancer researchers in China began to participate in the most important international clinical trials, such as INTETEST, IPASS, FASTACT, JMEN, TRUST, and so on, have access to professional training, contribute a large amount of lung cancer cases, and make Chinese voice heard. In 2007, based on international trial experiences, a national collaborative clinical research group, CTONG, was established. CTONG is a large network of researchers, surgeons, medical oncologists, radiation oncologists, statisticians, nurses/clinical research associates, health-care professionals and patient advocates at public institutions throughout China. Up to now, there have already been 25 top member hospitals. The purpose of this collaborative group is to carry out multi-center clinical trials for lung cancer, and provide high level of evidence-based medicine for clinical practices and translational researches. CTONG, an extremely active and well-organized study group, takes responsibility of carrying out phase I-IV clinical trials and translational research, establishing database of lung cancer patients and tissue bank, and promoting professional trainings as well as international communications. More than 10,000 new cases of lung cancer have been diagnosed and treated in CTONG hospitals every year, thus enabling China to initiate bio-marker driven trials rapidly. CTONG have already published major studies such as OPTIMAL, INFORM and FASTACT 2 just within a few years since establishment, contributing substantially to lung cancer patients and being expected to obtain more triumphs.
Apart from trials for advanced NSCLC, series of peri-operative trials about adjuvant and neoadjuvant chemotherapy/EGFR-tyrosine kinase inhibitor (EGFR-TKI) are being conducted by CTONG (Figure 2). Adjuvant cisplatin-based chemotherapy is recommended for routine use in patients with Stage IIA, IIB, and IIIA NSCLCs after complete resection and thus cisplatin and vinorelbine combination act as standard therapy. In addition, activating somatic mutations of tyrosine kinase domains of EGFR have been characterized in a subset of patients with advanced NSCLC. The EGFR mutation rate was 40–50% in Asia NSCLC population. Patients harboring these mutations show excellent response to EGFR-TKIs. In Sep 2011, investigator-initiated multicenter randomized phase III clinical trial in China (Adjuvant, CTONG 1104) initiated adjuvant gefitinib studies in EGFR mutant NSCLC, when Japan (IMPACT; WJOG6401L) has a similar design at the same time. A total number of 220–230 completely resected IIIA-II/N2-N1 NSCLC patients with EGFR mutation would be randomized (1:1) into gefitinib versus combination of vinorelbine plus platinum group as adjuvant treatment. The primary endpoint is DFS. Despite of competition about patients enrolling between Japan and China, the final data will be independently published but pooled in collaboration. At the beginning stage of CTONG 1104, the enrollment was slow due to single origin of candidates. Following with researcher conferences, further coordination and communications between PIs, and promotion of multi-center, enrollment began to accelerate apparently from Sep 2012 and has finished enrollment now (Figures 3,4).
(Enlarge Image)
Figure 2.
CTONG trials—establish lung cancer treatment modalities of China and East Asians style. CTONG, Chinese Thoracic Oncology Group.
(Enlarge Image)
Figure 3.
CTONG 1104 (adjuvant). CTONG, Chinese Thoracic Oncology Group.
(Enlarge Image)
Figure 4.
Enrollment of CTONG 1104 (adjuvant). CTONG, Chinese Thoracic Oncology Group.
It is imperative to unite regulatory authorities, clinical trial sponsors, collaborative research groups, research nurses, study coordinators and data managers together to expedite study approval for clinical trials. There are several time internals act as bottlenecks which restrict progressions of trials to a large extent, such as regulatory approval, ethics approval, protocol amendments, time for patient enrollment, just name a few. When designing trial protocols, researchers have compared between different clinical trials, like ACOSOG-Z0030, LCSG 821, JCOG 0802, CALGB 140503, CALGB 39802, CHEST, NATCH, CSLC 0501, CTONG 1103 and CTONG 1104 on respects of collaborative research groups, financial support, collection of current evidence, trial design and planning, regulatory affairs, trial period activities, follow-up and data management. These trials have demonstrated surgeons' ability to acquire fresh tissues when operating for central specimen bank storage. Surgeons have taken on the complex task of obtaining patients' written informed consents for tissue acquisition and laboratory investigations. These trials enable patients to obtain easier access to innovative therapies and enhance the efficiency and quality of clinical researches, thus requiring surgeons taking more responsibility to successfully accrue patients with early-stage diseases. Effective cooperative group system would throw highlight on the promising future of thoracic malignancy therapy.
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