Adjuvant Chemotherapy for High Risk Stage I Lung Adenocarcinoma (ECTOP-1004)

July 18, 2023 updated by: Haiquan Chen, Fudan University

Adjuvant Chemotherapy Versus Observation in Fully Resected Stage I Lung Adenocarcinoma With High Risk of Post-operative Recurrence

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1004. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

This study is recognized in our institute as "Eastern Cooperative Thoracic Oncology Projects (ECTOP-1004)"

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
up to 5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recurrence pattern
Time Frame: up to 5 years
locoregional recurrence, metastatic recurrence, or both.
up to 5 years
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.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Haiquan Chen, MD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECTOP-1004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Neoplasms

Clinical Trials on cisplatin plus pemetrexed

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings