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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
Sponsor:
Information provided by (Responsible Party):
Haiquan Chen, Fudan University

Brief Summary:
Solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation are high risk factors of post-operative recurrence for early-stage lung adenocarcinoma patients. The purpose of this clinical trial is to determine whether the widely used adjuvant chemotherapy strategy cisplatin/ pemetrexed is more effective than no further treatment for Stage pI lung adenocarcinoma patients with high post-operative recurrence risk - in terms of no dose related toxicities, premature treatment withdrawal or death.

Condition or disease Intervention/treatment Phase
Lung Neoplasms Drug: cisplatin plus pemetrexed Phase 2 Phase 3

Detailed Description:

Background:

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.

Objective:

  1. 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)
  2. To assess the safety and efficacy of chemotherapy regimen cisplatin plus pemetrexed to fully resected stage pI high-recurrent-risk patients.
  3. To collect clinical pathological characteristics and prognosis information of stage pI patients with solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation.
  4. To determine the association among age, gender, smoking history, pathological subtypes, histological differentiation, pleural involvement, vascular involvement and driving mutations.

Randomization:

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.

Follow up:

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

Secondary endpoints:

  1. Overall survival
  2. Recurrence pattern: Locoregional recurrence, metastatic recurrence, or both
  3. 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Recurrence pattern [ Time Frame: up to 5 years ]
    locoregional recurrence, metastatic recurrence, or both.

  2. 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.




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Stage pI lung adenocarcinoma confirmed through formalin-fixed paraffin-embedded tumor tissue, complete resection with mediastinal lymph node dissection
  2. Meet one of following conditions: a, Solid predominant adenocarcinomas; b, micropapillary predominant adenocarcinoma; c, low differentiation, unable to identify histological subtypes; d, pleural involvement; e, vascular involvement with solid subtype component or micropapillary component.
  3. Aged 18-70 years old.
  4. Eastern Cooperative Oncology Group score standard (ECOG) status 0-1.
  5. Medical condition permits adjuvant chemotherapy.
  6. Patients accept the clinical trial protocol and Informed Consent Form (ICF) signed.

Exclusion Criteria:

  1. Concurrent other malignancies
  2. Prior chemotherapy and/or radiation therapy for lung cancer
  3. Central type lung cancer
  4. Concurrent other unresected suspicious nodules or masses in lung
  5. Medical condition that will not permit treatment or follow up according to the protocol, or ECOG status >1.
  6. Pregnant or nursing women.

Information from the National Library of Medicine

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


Contacts
Contact: Haiquan Chen, MD +86-21 64175590 ext 1707 hqchen1@yahoo.com

Locations
China, Shanghai
Fudan University Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Chen Haiquan, MD    +86-21 64175590 ext 1707    hqchen1@yahoo.com   
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Haiquan Chen, MD Fudan University

Publications:

Responsible Party: Haiquan Chen, Chief,department of thoracic surgery, Fudan University Shanghai Cancer Center, Fudan University
ClinicalTrials.gov Identifier: NCT03380468     History of Changes
Other Study ID Numbers: Stage-1
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haiquan Chen, Fudan University:
Lung adenocarcinoma
adjuvant chemotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Adenocarcinoma
Recurrence
Carcinoma
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors