Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030771
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2002-02-14
Brief Title:
Preoperative Chemoradiotherapy vs Chemotherapy Alone in NSCLC Patients
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Preoperative Chemoradiotherapy vs Chemotherapy Alone in Non-small Cell Lung Cancer NSCLC Patients With Mediastinal Lymph Node Metastases Stage IIIA N2 A Randomized Prospective Phase III Trial
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as docetaxel and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Giving chemotherapy with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed It is not yet known if chemotherapy plus radiation therapy is more effective than chemotherapy alone before surgery in treating non-small cell lung cancer
PURPOSE This randomized phase III trial is studying docetaxel and cisplatin with or without radiation therapy to see how well they work when given before surgery in treating patients with stage IIIA non-small cell lung cancer that has spread to lymph nodes in the chest
PURPOSE This randomized phase III trial is studying docetaxel and cisplatin with or without radiation therapy to see how well they work when given before surgery in treating patients with stage IIIA non-small cell lung cancer that has spread to lymph nodes in the chest
Detailed Description:
The main objective of this trial is to compare feasibility and efficacy of sequential neoadjuvant chemoradiotherapy with 44 Gy concomitant boost to neoadjuvant chemotherapy alone
Secondary objectives are to assess the value of PET in predicting pathological response and eventfree survival in stage IIIA NSCLC and a health economic analysis of the two regimens Further to compare the amount of serum DNA in patients with stage IIIA pN2 NSCLC before chemotherapy before surgery and at the second follow-up visit ie four months after surgery or treatment failure for patients who can not be operated in patients randomized into the trial SAKK 1600 and to correlate the DNA variation with tumor response remission duration and overall survival
OUTLINE This is a prospective randomized phase III trial Patients are stratified according to mediastinal bulk 5 cm or more vs less than 5 cm weight loss in the past 6 months 5 or more vs less than 5 and participating center Patients are randomized to 1 of 2 treatment arms
Secondary objectives are to assess the value of PET in predicting pathological response and eventfree survival in stage IIIA NSCLC and a health economic analysis of the two regimens Further to compare the amount of serum DNA in patients with stage IIIA pN2 NSCLC before chemotherapy before surgery and at the second follow-up visit ie four months after surgery or treatment failure for patients who can not be operated in patients randomized into the trial SAKK 1600 and to correlate the DNA variation with tumor response remission duration and overall survival
OUTLINE This is a prospective randomized phase III trial Patients are stratified according to mediastinal bulk 5 cm or more vs less than 5 cm weight loss in the past 6 months 5 or more vs less than 5 and participating center Patients are randomized to 1 of 2 treatment arms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20138 | Other Identifier | SAKK | None |
| SWS-SAKK-1600 | OTHER | None | None |