AdjuvantNCT00484016

Drug Delivery and Toxicities of Adjuvant Chemotherapy in Resected NCSLC

An observational study of Adjuvant and Chemotherapy, run by Washington University School of Medicine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

There are limited numbers of retrospective studies showing the effectiveness of adjuvant chemotherapy over observation in resected lung cancers. Read more about this study

Who is it for?: Ages 18 to 88 years
Conditions the study is for: Adjuvant, Chemotherapy, Lung
How many people: 45 participants
Where: No sites listed yet
Study dates: Feb 2006to Apr 2007
Phase: Observational
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 to 88 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients that received adjuvant chemotherapy
18-88 years

Who cannot join

Any patients that have not received adjuvant chemotherapy
Patients under 18 or over 88

About this study

Official title: Drug Delivery and Toxicities of Adjuvant Chemotherapy in Resected Non Small Cell Lung Cancer

There are limited numbers of retrospective studies showing the effectiveness of adjuvant chemotherapy over observation in resected lung cancers.

Read the detailed description

We propose to retrospectively examine the Washington University School of Medicine experience on all patients receiving adjuvant chemotherapy between 2003 and 2005. We will retrospectively analyze the survival and outcomes in the lung cancer patients receiving adjuvant chemotherapy following surgical resection.

Conditions: Adjuvant, Chemotherapy, Lung, Cancers
Keywords: adjuvant, chemotherapy, observation, resected, cancers
Medical subject headings: Neoplasms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2006Apr 2007

First posted8 Jun 2007 (estimated)
Study startFeb 2006
Primary completionApr 2007
Study completionApr 2007

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 AdjuvantStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
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: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00484016
Sponsor's protocol ID: 06-0155
Status last verified: Aug 2013
First submitted: 4 Jun 2007
Last updated: 13 Aug 2013
Results posted: No
Data monitoring committee: No

Publications

Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J; International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med. 2004 Jan 22;350(4):351-60. doi: 10.1056/NEJMoa031644.
PubMed 14736927

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingPhase 2
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Non Small Cell Lung Cancer

All Adjuvant trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Delivery and Toxicities of Adjuvant Chemotherapy in Resected Non Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00484016
Acronym / sponsor ID: 06-0155
Conditions: Adjuvant, Chemotherapy, Lung, Cancers
Keywords: adjuvant, chemotherapy, observation, resected, cancers
Study type: Observational
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: Feb 2006
Primary completion: Apr 2007 (actual)
Study completion: Apr 2007 (actual)
First posted: 8 Jun 2007 (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.

There are limited numbers of retrospective studies showing the effectiveness of adjuvant chemotherapy over observation in resected lung cancers.

Detailed description

Study design

Observational model: Case only
Time perspective: Retrospective

Who may qualify

Ages: 18 to 88 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients that received adjuvant chemotherapy
18-88 years

Key exclusion criteria (2 listed)

Any patients that have not received adjuvant chemotherapy
Patients under 18 or over 88

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Not reported in the source record.

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 Aug 2013.
Results publication: PubMed 14736927Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J; International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med. 2004 Jan 22;350(4):351-60. doi: 10.1056/NEJMoa031644.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.

Related trials for Adjuvant

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingPhase 2
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Non Small Cell Lung Cancer

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.

Ramaswamy Govindan, M.D. principal investigator

Washington University School of Medicine

Questions about this trial

What is this clinical trial studying?

An observational study of Adjuvant and Chemotherapy, run by Washington University School of Medicine.

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 2 inclusion and 2 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 Aug 2013. 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.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00484016, 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 Aug 2013.