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
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This PHASE3 trial investigates Carcinoma, Non-Small-Cell Lung and is currently terminated or withdrawn.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
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE3
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Sep 2025 — Present [monthly]
Terminated PHASE3
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Sep 2024 — Sep 2025 [monthly]
Terminated PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE3
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Jan 2021 — Jul 2024 [monthly]
Terminated PHASE3
▶ Show 2 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Terminated PHASE3
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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
- Intergroupe Francophone de Cancerologie Thoracique
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Aix-en-Provence, France , Ambilly, France , Annecy, France , Auxerre, France , Bayonne, France , Beauvais, France , Besançon, France , Blois, France , Bobigny, France , Boulogne, France and 60 more locations