Adjuvant Chemotherapy for High Post-operative Recurrence Risk Stage pI Lung Adenocarcinoma (ACTPI)
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|ClinicalTrials.gov Identifier: NCT03380468|
Recruitment Status : Recruiting
First Posted : December 21, 2017
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms||Drug: cisplatin plus pemetrexed||Phase 2 Phase 3|
Management of lung cancer varies according to the clinical and pathological stage. For stage I lung adenocarcinoma, radical surgery is the preferred initial treatment and adjuvant chemotherapy is usually not recommended due to a fine prognosis and relatively low post-operative recurrence rate. Still, a number of stage pI patients will suffer a relapse after surgery, among which are highly associated with solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation. Recently, some retrospective researches have shown a significant survival benefit of adjuvant chemotherapy for such stage pI high-recurrent-risk patients, but there lacks evidence from prospective randomized clinical trails.
- Major: to compare disease free survival and over all survival of fully resected stage pI high-recurrent-risk patients from both arms (adjuvant chemotherapy vs. observation)
- To assess the safety and efficacy of chemotherapy regimen cisplatin plus pemetrexed to fully resected stage pI high-recurrent-risk patients.
- To collect clinical pathological characteristics and prognosis information of stage pI patients with solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation.
- To determine the association among age, gender, smoking history, pathological subtypes, histological differentiation, pleural involvement, vascular involvement and driving mutations.
Each of the patients enrolled will be recorded in the computer system. Blank randomization will be done using a digital randomization software, at least 1 week before the first time of chemotherapy or observation.
Prechemotherapy assessment: For all the patients enrolled, the postoperative physical or laboratory examination should be equally qualified no matter which group they will be in. For Group Adjuvant Chemotherapy patients, they will receive laboratory examinations before chemotherapy to test blood cells and liver function in consideration of safety as routine.
Patients will be followed up per 4 months for the first three years and each six months for the forth to fifth years during the research. Lung multi-detector row computed tomography (MDCT) and abdominal ultrasonography tests will be done twice a year; bone SPECT scan and enhanced brain MRI scan will be conducted per year routinely. Patients will be suggested to continue the annual follow-up after the research.
Main research variables:
Primary end point: Disease free survival in the two arms
- Overall survival
- Recurrence pattern: Locoregional recurrence, metastatic recurrence, or both
- Quality of life: assessed with Eastern Cooperative Oncology Group- quality of life questionnaire(EORTC QLQ-C30/- LC13) scale.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Chemotherapy Versus Observation in Fully Resected Stage I Lung Adenocarcinoma With High Risk of Post-operative Recurrence|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Cisplatin plus pemetrexed
Drug: cisplatin 75mg/m2 iv Drug: pemetrexed 500mg/m2 iv
Drug: cisplatin plus pemetrexed
cisplatin 75mg/m2 iv; pemetrexed 500mg/m2 iv
No Intervention: Observation
Observation and follow up only
- Recurrence free survival (RFS) [ Time Frame: up to 5 years ]from date of randomization until the date of showing signs of relapse, including evidence of medical image or pathology.
- Overall survival (OS) [ Time Frame: up to 5 years ]from date of randomization until the date of death from any cause, withdrawal of consent, or the end of the study.
- Recurrence pattern [ Time Frame: up to 5 years ]locoregional recurrence, metastatic recurrence, or both.
- Quality of life [ Time Frame: up to 5 years ]
assessed with Eastern Cooperative Oncology Group-quality of life questionnaire(EORTC QLQ-C30/- LC13) scale.
Discription of EORTC QLQ-C30/- LC13:
The full name of the scale is Eastern Cooperative Oncology Group- quality of life questionnaire, including a core scale (EORTC QLQ-C30, version 3.0) and a module specified for lung cancer (EORTC QLQ- LC13). The scale is authorized by Quality of Life Department, EORTC Headquarters (Avenue E Mounier 83 - B11, 1200 Brussels BELGIUM) for scientific research.
The scale ranges in score from 0 to 100. A higher score represents a a better health status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380468
|Contact: Haiquan Chen, MD||+86-21 64175590 ext email@example.com|
|Fudan University Cancer Center||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Chen Haiquan, MD +86-21 64175590 ext 1707 firstname.lastname@example.org|
|Principal Investigator:||Haiquan Chen, MD||Fudan University|