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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

300

Phase

  • 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 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

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
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

What is the study measuring?

Primary Outcome Measures

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

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

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

Fudan University

Investigators

  • 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)

January 1, 2018

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 1, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 21, 2017

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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