deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT00535275

NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy

Comparison of 2 Chemotherapy Regimens in Non-small-cell Lung Cancer (NSCLC) Patients Relapsing After Surgery and Peri-operative Chemotherapy. A Randomized Phase III Study.

Sponsor: Intergroupe Francophone de Cancerologie Thoracique

Updated 7 times since 2017 Last updated: Feb 12, 2015 Started: Sep 30, 2007 Primary completion: Nov 30, 2014 Completion: Nov 30, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Final analysis done, follow-up of patients no more necessary

This PHASE3 trial investigates Carcinoma, Non-Small-Cell Lung and is currently terminated or withdrawn. Intergroupe Francophone de Cancerologie Thoracique leads this study, which shows 7 recorded versions since 2007 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

As chemotherapy gains wider acceptance for the treatment of earlier stages of NSCLC, particularly in the adjuvant and neoadjuvant setting, physicians face a growing population of high performance status patients who have relapsed after their first-line chemotherapy. The type of second-line chemotherapy after initial adjuvant or neoadjuvant treatment with a platinum-based regimen remains largely undefined. Some might consider rechallenging patients with a platinum based doublet whereas others might treat these patients with a monochemotherapy (pemetrexed or docetaxel). Most relapses occurring after perioperative chemotherapy and surgery are non surgical locally advanced relapses or metastatic diseases. Some differences exist between these post surgical relapses and the progressions occurring after the first line non surgical treatment of a stage III/IV. * Patients are most often in a good condition (performance status 0-1). * Progression is often asymptomatic and diagnosed in the post surgical follow up. * The dose of chemotherapy previously administered is lower than that administered in first line of a stage III/IV. * The time between the first line of treatment and the treatment of the relapse is longer. These differences might be associated with a more chemosensitive disease and thus might be the rationale of using a platinum containing doublet...

As chemotherapy gains wider acceptance for the treatment of earlier stages of NSCLC, particularly in the adjuvant and neoadjuvant setting, physicians face a growing population of high performance status patients who have relapsed after their first-line chemotherapy. The type of second-line chemotherapy after initial adjuvant or neoadjuvant treatment with a platinum-based regimen remains largely undefined. Some might consider rechallenging patients with a platinum based doublet whereas others might treat these patients with a monochemotherapy (pemetrexed or docetaxel).

Most relapses occurring after perioperative chemotherapy and surgery are non surgical locally advanced relapses or metastatic diseases.

Some differences exist between these post surgical relapses and the progressions occurring after the first line non surgical treatment of a stage III/IV.

* Patients are most often in a good condition (performance status 0-1). * Progression is often asymptomatic and diagnosed in the post surgical follow up. * The dose of chemotherapy previously administered is lower than that administered in first line of a stage III/IV. * The time between the first line of treatment and the treatment of the relapse is longer.

These differences might be associated with a more chemosensitive disease and thus might be the rationale of using a platinum containing doublet instead of the classical mono chemotherapy docetaxel or pemetrexed.

Thus, the current study has been designed to answer these questions.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 7 months · monthly snapshotTerminated~Jan 2026 – present · 3 months · monthly snapshotTerminated

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated PHASE3

  2. Sep 2025 — Present [monthly]

    Terminated PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  5. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE3

Show 2 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE3

  2. Jan 2017 — Jun 2018 [monthly]

    Terminated PHASE3

    First recorded

Sep 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Intergroupe Francophone de Cancerologie Thoracique
Data source: Intergroupe Francophone de Cancerologie Thoracique

For direct contact, visit the study record on ClinicalTrials.gov .