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Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%

ConditionsChemotherapy, AdjuvantLung Adenocarcinoma, Stage ITreatmentHistological Type of Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-70
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

Randomized phase II trial aims to compare surgery with or without adjuvant chemotherapy in treating patients who are pathologically diagnosed as stage I lung adenocarcinoma with micropapillary component no less than 20%.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Completely resected Stage I NSCLC as defined by the International Staging System

Pathologically diagnosed Stage I micropapillary predominant lung adenocarcinoma

Patients must be randomized within 4 weeks from the date of surgery

No prior chemotherapy or radiation for non-small cell lung cancer

Disqualifiers

Do not meet the inclusion criteria

There is evidence of distant metastases

Suffered from other malignancies in five years

Within the past January subjects received other drug trials

Trial design

Design model

Parallel

Treatments tested in this trial

  • cis Platinum/Carboplatin, Pemetrexed Disodium

    Drug

    Intravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours

  • Undergo surgery

    Procedure/Surgery

    Therapeutic conventional surgery, R0 resection

Treatment groups

460 Participants
are divided into 2 treatment groups
Group A: Arm IActive comparator 1 intervention
Group B: Arm IIExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Disease-Free-Survival-Rate

the percentage of people in the trial who are alive and cancer free after a specified number of years

Time frame
up to 60 months

Secondary outcomes

1

Overall-Survival-Rate

the percentage of people in the trial who alive, with or without signs of cancer

Time frame
up to 60 months
2

Disease-Free-Survival-Time

From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first

Time frame
up to 60 months
3

Overall-Survival-Time

Time from randomization until death from any cause

Time frame
up to 60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Pulmonary Hospital, Shanghai, China

Lead sponsor

Source ClinicalTrials.gov
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