Non-Small-Cell Lung CancerPhase 3NATCHNCT00913705
Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer
A Phase 3 study testing Neoadjuvant chemotherapy (taxol and carboplatin), Adjuvant chemotherapy (taxol and carboplatin) and Surgery in people with Non-Small-Cell Lung Cancer, run by Spanish Lung Cancer Group.
Trial summary
Open-label multicenter randomized Phase III trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- Neoadjuvant chemotherapy (taxol and carboplatin), Adjuvant chemotherapy (taxol and carboplatin) and Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 624 participants
- Where
- No sites listed yet
- Study dates
- Sep 1999to Jun 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients eligible for the study are those with a diagnosis, histologically or cytologically proven, of NSCLC without metastases at stages IB, IIA, IIB and IIIA (not N2) of the disease. Patients with stage IA and tumor size >2cm will be eligible as well.
- Patients aged > 18 years.
- Tumor considered resectable by the attending surgeon.
- The patient must have an ECOG *2 or Karnofsky >60%.
- The patients need to have adequate hematological, renal and hepatic function defined as:
- Absolute neutrophil counts (ANC) 1.5 x 109/L Platelet counts 100 x 109/L Total bilirubin 1.25 x upper limit of normal distribution Serum creatinine <120 umol/L (<1.5 mg/dl) Creatinine clearance >60 ml/min
Show all 11Show fewer
- ANC = segmented neutrophils + banded neutrophils
- The patients should have recovered from any serious surgical sequellae.
- Informed consent must be obtained from the patient in accordance with the requirements of the IRB/EC.
- If female, the patient must not be pregnant or breast-feeding. Women of child bearing potential need to have a pregnancy test performed and to take appropriate contraceptive action during the period of the study.
- Operability criteria: Lung function test will be performed so as to confirm a predictive postoperative value of FEV-1 >-800 ml, i.e. correct homeostasis. A carbon monoxide diffusion test is to be conducted and, when applicable, repeated following the induction treatment while taking into account the sensitivity of post-chemotherapy pulmonary toxicity detection.
Who cannot join
- Patients who have previously been treated with chemotherapy and/or radiotherapy.
- History of significant cardiovascular disease such as non-controlled hypertension, unstable angina or congestive heart failure even if these are controlled by medication. Documented history of acute myocardial infarction in the previous year, ventricular arrhythmias that required medication or 2nd or 3rd atrial-ventricular blocks.
- Pre-existing sensory or motor neurotoxicity grade >2 based on the WHO criteria.
- Active infection or other clinical state that could seriously reduce the patient's capacity to tolerate the treatment protocol, including previous allergic reactions to products containing Cremophor (e.g. cyclosporin or vitamin K).
- Previous or concomitant malignant tumor (with the exception of in situ cervical carcinoma, baso-cellular carcinoma, squamous cell skin carcinoma or urothelial superficial carcinoma) which are considered potentially curable with oncological treatment and have a disease free survival (DFS) greater than 5 years EXCEPTING breast cancer, melanoma and hypernephroma
- Marked psychoses or senility
About this study
Official title: Randomized Trial of Surgery With or Without Paclitaxel Plus Carboplatin as Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable, Non-small-cell Lung Cancer
Open-label multicenter randomized Phase III trial.
Read the detailed description
Randomized trial of surgery with or without Paclitaxel (taxol) plus Carboplatin as neoadjuvant or adjuvant chemotherapy in patients with operable, non-small-cell lung cancer.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Neoadjuvant chemotherapy (taxol and carboplatin), Adjuvant chemotherapy (taxol and carboplatin), Surgery
- Keywords
- NATCH, LUNG, OPERABLE NSCLC, SURGERY PLUS ADJUVANT THERAPY, SURGERY PLUS NEOADJUVANT THERAPY
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemotherapy (taxol and carboplatin)Drug
Taxol: 200mg/m2 infusion over 3 hours; Carboplatin: AUC= 6 at the end of the Taxol infusion. Administration of 3 cycles at 21-day intervals. Prior to surgery.
Adjuvant chemotherapy (taxol and carboplatin)Drug
Taxol: 200mg/m2 infusion over 3 hours; Carboplatin: AUC= 6 at the end of the Taxol infusion. Administration of 3 cycles at 21 days interval. Post-surgery
SurgeryProcedure or surgery
Surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The patients will be randomized to receive taxol (Paclitaxel) and carboplatin as adjuvant or as neoadjuvant regimen or to surgery alone Receives: Drug: Neoadjuvant chemotherapy (taxol and carboplatin); Drug: Adjuvant chemotherapy (taxol and carboplatin); Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate disease-free survival (DFS) and overall survival (OS)
DFS: defined as the length of time from the date of diagnosis to the date of the first documented progression of disease OS: defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.
Measured: 5 years
Secondary outcomes (1)
Evaluate levels of response and the adverse effects of the chemotherapy
Occurrence and severity of adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startSep 1999
- Primary completionDec 2007
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 624 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spanish Lung Cancer Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enriqueta Felip, MD, Principal investigator, HOSPITAL VALL D'HEBRON (Barcelona)Rafael Rosell, MD, Principal investigator, ICO-HOSPITAL UNIV. GERMANS TRIAS I PUJOL (Badalona)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913705
- Sponsor's protocol ID
- NATCH - GECP 99/02
- Acronym
- NATCH
- Status last verified
- Jun 2022
- First submitted
- 2 Jun 2009
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Felip E, Rosell R, Maestre JA, Rodriguez-Paniagua JM, Moran T, Astudillo J, Alonso G, Borro JM, Gonzalez-Larriba JL, Torres A, Camps C, Guijarro R, Isla D, Aguilo R, Alberola V, Padilla J, Sanchez-Palencia A, Sanchez JJ, Hermosilla E, Massuti B; Spanish Lung Cancer Group. Preoperative chemotherapy plus surgery versus surgery plus adjuvant chemotherapy versus surgery alone in early-stage non-small-cell lung cancer. J Clin Oncol. 2010 Jul 1;28(19):3138-45. doi: 10.1200/JCO.2009.27.6204. Epub 2010 Jun 1.
PubMed 20516435
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Surgery With or Without Paclitaxel Plus Carboplatin as Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable, Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00913705
- Acronym / sponsor ID
- NATCH / NATCH - GECP 99/02
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- NATCH, LUNG, OPERABLE NSCLC, SURGERY PLUS ADJUVANT THERAPY, SURGERY PLUS NEOADJUVANT THERAPY
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- Spanish Lung Cancer GroupUniversity, hospital or other
- Study start
- Sep 1999
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label multicenter randomized Phase III trial.
Detailed description
Randomized trial of surgery with or without Paclitaxel (taxol) plus Carboplatin as neoadjuvant or adjuvant chemotherapy in patients with operable, non-small-cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Neoadjuvant chemotherapy (taxol and carboplatin), Drug: Adjuvant chemotherapy (taxol and carboplatin), Procedure: SurgeryThe patients will be randomized to receive taxol (Paclitaxel) and carboplatin as adjuvant or as neoadjuvant regimen or to surgery alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The patients eligible for the study are those with a diagnosis, histologically or cytologically proven, of NSCLC without metastases at stages IB, IIA, IIB and IIIA (not N2) of the disease. Patients with stage IA and tumor size >2cm will be eligible as well.
- Patients aged > 18 years.
- Tumor considered resectable by the attending surgeon.
- The patient must have an ECOG *2 or Karnofsky >60%.
- The patients need to have adequate hematological, renal and hepatic function defined as:
Key exclusion criteria (6 listed)
- Patients who have previously been treated with chemotherapy and/or radiotherapy.
- History of significant cardiovascular disease such as non-controlled hypertension, unstable angina or congestive heart failure even if these are controlled by medication. Documented history of acute myocardial infarction in the previous year, ventricular arrhythmias that required medication or 2nd or 3rd atrial-ventricular blocks.
- Pre-existing sensory or motor neurotoxicity grade >2 based on the WHO criteria.
- Active infection or other clinical state that could seriously reduce the patient's capacity to tolerate the treatment protocol, including previous allergic reactions to products containing Cremophor (e.g. cyclosporin or vitamin K).
- Previous or concomitant malignant tumor (with the exception of in situ cervical carcinoma, baso-cellular carcinoma, squamous cell skin carcinoma or urothelial superficial carcinoma) which are considered potentially curable with oncological treatment and have a disease free survival (DFS) greater than 5 years EXCEPTING breast cancer, melanoma and hypernephroma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant chemotherapy (taxol and carboplatin)Taxol: 200mg/m2 infusion over 3 hours; Carboplatin: AUC= 6 at the end of the Taxol infusion. Administration of 3 cycles at 21-day intervals. Prior to surgery. | Drug | 1 |
| Adjuvant chemotherapy (taxol and carboplatin)Taxol: 200mg/m2 infusion over 3 hours; Carboplatin: AUC= 6 at the end of the Taxol infusion. Administration of 3 cycles at 21 days interval. Post-surgery | Drug | 1 |
| SurgerySurgery | Procedure or surgery | 1 |
Primary outcome
Evaluate disease-free survival (DFS) and overall survival (OS)
Time frame: 5 years
DFS: defined as the length of time from the date of diagnosis to the date of the first documented progression of disease OS: defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.
1 secondary outcome
Evaluate levels of response and the adverse effects of the chemotherapy
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Results publication: PubMed 20516435Felip E, Rosell R, Maestre JA, Rodriguez-Paniagua JM, Moran T, Astudillo J, Alonso G, Borro JM, Gonzalez-Larriba JL, Torres A, Camps C, Guijarro R, Isla D, Aguilo R, Alberola V, Padilla J, Sanchez-Palencia A, Sanchez JJ, Hermosilla E, Massuti B; Spanish Lung Cancer Group. Preoperative chemotherapy plus surgery versus surgery plus adjuvant chemotherapy versus surgery alone in early-stage non-small-cell lung cancer. J Clin Oncol. 2010 Jul 1;28(19):3138-45. doi: 10.1200/JCO.2009.27.6204. Epub 2010 Jun 1.
- Web page of the sponsor where users can find more information about Fundación GECP studiesLink provided by the sponsor.
Related trials for Non-Small-Cell Lung Cancer
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic
RecruitingObservational study
Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
HER2-mutant Advanced Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 2
Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enriqueta Felip, MD principal investigator
HOSPITAL VALL D'HEBRON (Barcelona)
Rafael Rosell, MD principal investigator
ICO-HOSPITAL UNIV. GERMANS TRIAS I PUJOL (Badalona)
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neoadjuvant chemotherapy (taxol and carboplatin), Adjuvant chemotherapy (taxol and carboplatin) and Surgery in people with Non-Small-Cell Lung Cancer, run by Spanish Lung Cancer Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate disease-free survival (DFS) and overall survival (OS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00913705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.