Colon AdenocarcinomaNCT04526314
Treatment and Outcomes of Stage III Colon Cancer in Patients 80 Years of Age and Older
An observational study of Colon Adenocarcinoma, run by Registre des Tumeurs Digestives du Finistère at 1 site in France.
Trial summary
The objective of this study was to assess survival trends in elderly patients with stage III colon cancer Read more about this study
- Who is it for?
- Ages 80 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Adenocarcinoma
- What is being tested?
- observational
- How many people
- 308 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 1 Jul 2020
- 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 80 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: clinical data
Who may be able to join
- Stage 3 colon adenocarcinoma
Who cannot join
- Rectal tumors
- Patients receiving neo-adjuvant chemotherapy or radiotherapy
- Tumours of the appendix
- Tumours with histology other than adenocarcinoma
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study was to assess survival trends in elderly patients with stage III colon cancer
Read the detailed description
This retrospective population-based study included patients aged 80 years and older with stage III colon adenocarcinoma who underwent surgery between 2007 and 2014.
- Conditions
- Colon Adenocarcinoma
- Being tested
- observational
- Keywords
- stage 3 colon cancer, elderly, survival, surgery, chemotherapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
observational
| Study group | Role | What they receive |
|---|---|---|
| Stage 3 with adjuvant chemotherapy | Not described Receives: Other: observational | |
| Stage 3 without adjuvant chemotherapy | Not described Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
months
Measured: 2007-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2020
- Study completion1 Jul 2020
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 Colon AdenocarcinomaStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Registre des Tumeurs Digestives du Finistère
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Robaskiewicz, MD PhD, Study chair, REGISTRE DES TUMEURS DIGESTIVES DU FINISTERE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526314
- Sponsor's protocol ID
- 908270
- Status last verified
- Aug 2020
- First submitted
- 15 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Badic B, Oguer M, Cariou M, Kermarrec T, Bouzeloc S, Nousbaum JB, Robaszkiewicz M, Queneherve L. Prognostic factors for stage III colon cancer in patients 80 years of age and older. Int J Colorectal Dis. 2021 Apr;36(4):811-819. doi: 10.1007/s00384-021-03861-6. Epub 2021 Feb 2.
PubMed 33528749
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Outcomes of Stage III Colon Cancer in Patients 80 Years of Age and Older
- ClinicalTrials.gov ID
- NCT04526314
- Acronym / sponsor ID
- 908270
- Conditions
- Colon Adenocarcinoma
- Keywords
- stage 3 colon cancer, elderly, survival, surgery, chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Registre des Tumeurs Digestives du FinistèreUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 25 Aug 2020 (actual)
- 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 objective of this study was to assess survival trends in elderly patients with stage III colon cancer
Detailed description
This retrospective population-based study included patients aged 80 years and older with stage III colon adenocarcinoma who underwent surgery between 2007 and 2014.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 3 with adjuvant chemotherapy | – | Other: observational |
| Stage 3 without adjuvant chemotherapy | – | Other: observational |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- clinical data
Key inclusion criteria (1 listed)
- Stage 3 colon adenocarcinoma
Key exclusion criteria (4 listed)
- Rectal tumors
- Patients receiving neo-adjuvant chemotherapy or radiotherapy
- Tumours of the appendix
- Tumours with histology other than adenocarcinoma
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 |
|---|---|---|
| observationalobservational | Other | Stage 3 with adjuvant chemotherapy, Stage 3 without adjuvant chemotherapy |
Primary outcome
Overall survival
Time frame: 2007-2014
months
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 25 Aug 2020.
- Derived from this study: PubMed 33528749Badic B, Oguer M, Cariou M, Kermarrec T, Bouzeloc S, Nousbaum JB, Robaszkiewicz M, Queneherve L. Prognostic factors for stage III colon cancer in patients 80 years of age and older. Int J Colorectal Dis. 2021 Apr;36(4):811-819. doi: 10.1007/s00384-021-03861-6. Epub 2021 Feb 2.
- Individual participant dataSharing planned: No
Related trials for Colon Adenocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian 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.
Michel Robaskiewicz, MD PhD study chair
REGISTRE DES TUMEURS DIGESTIVES DU FINISTERE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Adenocarcinoma, run by Registre des Tumeurs Digestives du Finistère at 1 site in France.
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 1 inclusion and 4 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 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?
Overall survival (time frame: 2007-2014). 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 NCT04526314, 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 25 Aug 2020.