Lung CancerNCT00822016
Observational Study of Best Supportive Care With or Without Surgery, Chemo or Radiotherapy in Pts With Carcinoma of Lung
An observational study of Lung Cancer, run by New Mexico Cancer Research Alliance at 2 sites in United States.
Trial summary
The purpose of this study is to establish a listing (database) of patients diagnosed with lung cancer and treated with best supportive care and standard and investigational chemotherapy regimens, surgery, and radiation therapy at the UNM CRTC and other NMCCA sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Mar 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with lung cancer and treated with best supportive care and standard and investigational chemotherapy regimens, surgery, and radiation therapy at the UNM CRTC and other NMCCA sites.
Who may be able to join
- Those who are eligible for this treatment protocol will consist of:
- Patients with histologically diagnosed lung cancer.
- Patients receiving therapy should have an ECOG/Zubrod/SWOG performance status of <3 at the time of the initiation of therapy.
- All newly diagnosed patients referred to an NMCC Alliance site will be eligible, as will patients with recurrent disease that are now referred to an NMCCA for their next therapy (such as those who move from out of state, or are referred for protocol therapy), though efforts will be made to obtain records of prior therapy administered elsewhere).
Who cannot join
- Patients not falling under any of the above criteria are not eligible for the study.
- Withdrawal of the informed consent at any point in the study excludes patient from the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, 87102
Universtiy of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-0001
About this study
Official title: INST 0701C: An Observational Outcomes Protocol of Standard Practice of Best Supportive Care With or Without Surgery, Chemotherapy or Radiotherapy in Patients With Carcinoma of the Lung
The purpose of this study is to establish a listing (database) of patients diagnosed with lung cancer and treated with best supportive care and standard and investigational chemotherapy regimens, surgery, and radiation therapy at the UNM CRTC and other NMCCA sites. The information will be used to determine the results of various treatments for lung cancer subjects and to find where improvements can be made in safety, effectiveness, supportive care, treatment that eases tumors without curing them, treatments that cure tumors, prevention, and follow-up efforts. The database information will be compared to clinical trial data published in peer-reviewed journals and SEER outcome data. Patients will be acquired both before and after they are treated for lung cancer.
Read the detailed description
Same as above.
- Conditions
- Lung Cancer
- Keywords
- Best Supportive Care, Protocol of Standard Practice, Carcinoma of the Lung
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To document the progression-free survival, rate of response, median duration of response, & median overall survivals, of subjects receiving best supportive care with or without standard surgery, chemotherapy and/or radiation therapy for lung cancer
Measured: 3-6 months
Secondary outcomes (1)
To document the incidence and severity of toxicities, and reversibility of toxicities of subjects as a function of the treatments rendered.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startJul 2007
- Primary completionDec 2010
- Study completionMar 2011
Why it stopped: PI left institution. Insufficient enrollment for analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennie Jones, M.D., Principal investigator, University of New Mexico Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822016
- Sponsor's protocol ID
- INST 0701C
- Status last verified
- Jun 2012
- First submitted
- 13 Jan 2009
- Last updated
- 29 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INST 0701C: An Observational Outcomes Protocol of Standard Practice of Best Supportive Care With or Without Surgery, Chemotherapy or Radiotherapy in Patients With Carcinoma of the Lung
- ClinicalTrials.gov ID
- NCT00822016
- Acronym / sponsor ID
- INST 0701C
- Conditions
- Lung Cancer
- Keywords
- Best Supportive Care, Protocol of Standard Practice, Carcinoma of the Lung
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution. Insufficient enrollment for analysis.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 Jan 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.
The purpose of this study is to establish a listing (database) of patients diagnosed with lung cancer and treated with best supportive care and standard and investigational chemotherapy regimens, surgery, and radiation therapy at the UNM CRTC and other NMCCA sites. The information will be used to determine the results of various treatments for lung cancer subjects and to find where improvements can be made in safety, effectiveness, supportive care, treatment that eases tumors without curing them, treatments that cure tumors, prevention, and follow-up efforts. The database information will be compared to clinical trial data published in peer-reviewed journals and SEER outcome data. Patients will be acquired both before and after they are treated for lung cancer.
Detailed description
Same as above.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with lung cancer and treated with best supportive care and standard and investigational chemotherapy regimens, surgery, and radiation therapy at the UNM CRTC and other NMCCA sites.
Key inclusion criteria (4 listed)
- Those who are eligible for this treatment protocol will consist of:
Key exclusion criteria (2 listed)
- Patients not falling under any of the above criteria are not eligible for the study.
- Withdrawal of the informed consent at any point in the study excludes patient from the study.
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
To document the progression-free survival, rate of response, median duration of response, & median overall survivals, of subjects receiving best supportive care with or without standard surgery, chemotherapy and/or radiation therapy for lung cancer
Time frame: 3-6 months
1 secondary outcome
To document the incidence and severity of toxicities, and reversibility of toxicities of subjects as a function of the treatments rendered.
Time frame: 3-6 months
Results and safety
The study was stopped early (reason given: PI left institution. Insufficient enrollment for analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
Related trials for Lung Cancer
RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
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
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
Dennie Jones, M.D. principal investigator
University of New Mexico Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by New Mexico Cancer Research Alliance at 2 sites in United States.
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 4 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: stopped early, as of the sponsor's last update on 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: PI left institution. Insufficient enrollment for analysis.). Results are not available in the source record.
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?
To document the progression-free survival, rate of response, median duration of response, & median overall survivals, of subjects receiving best supportive care with or without standard surgery, chemotherapy and/or radiation therapy for lung cancer (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2012.