Rectal CancerNCT04759638
Short Running Head Obesity in Rectal Cancer Patients
An observational study of Rectal Cancer, run by King Hussein Cancer Center at 1 site in Jordan.
Trial summary
There is a controversy regarding the effect of the two Body Mass Index (BMI) extremes on the oncological outcome of rectal cancer. The obesity paradox appears to exist in rectal cancer patients treated with nCRT and surgery, as it was associated with significantly higher rates of pathological complete response and R0… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer
- How many people
- 294 participants
- Where
- 1 siteJordan
- Study dates
- 21 Mar 2017to 25 Mar 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 Any age
- Child, Adult, Older adult
Study population: 294 patients included in the study
Who may be able to join
- Patients who underwent rectal surgery at King Hussein Cancer Center (KHCC) from 2006 to 2018 were identified. Those with locally advanced rectal cancer (stages II and III) who underwent nCRT followed by surgery with curative intent were included.
Who cannot join
- Patients with early rectal cancer (stage I) who did not require nCRT and those who underwent rectal surgery as part of a staged or simultaneous approach for metastatic disease (stage IV) were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Mass Index Role in the Oncological Outcome of Locally Advanced Rectal Cancer: The Two BMI Extremes as Comparative Groups, A Retrospective Study
There is a controversy regarding the effect of the two Body Mass Index (BMI) extremes on the oncological outcome of rectal cancer.
The obesity paradox appears to exist in rectal cancer patients treated with nCRT and surgery, as it was associated with significantly higher rates of pathological complete response and R0 resection.
Underweight patients were at higher risk for anastomotic leak and R1 resection.
Read the detailed description
Background:
Obesity and underweight are associated with increased risk of postoperative morbidity in colorectal cancer patients undergoing surgery. There is a controversy regarding the effect of the two Body Mass Index (BMI) extremes on the oncological outcome of rectal cancer.
Objective:
The aim of this study was to evaluate the effect of BMI on short- and long-term oncological outcomes as well as postoperative complications in rectal cancer patients who received neoadjuvant chemoradiotherapy (nCRT) followed by surgery.
Setting:
Tertiary Cancer Center serving pediatric and adult patients in Jordan and the Middle East.
Patients:
The medical records of patients with stage II-III rectal cancer who received nCRT followed by surgery during 2006 to 2018 were retrospectively reviewed. The patients were subdivided according to their BMI into less than 20 kg/m2 defined as underweight; between 20 to 30 kg/m2 defined as normal range weight, above 30 kg/m2 defined as obese.
Main Outcome Measures:
Disease-Free Survival (DFS), Overall Survival, Pathological Complete Response (CR)
- Conditions
- Rectal Cancer
- Keywords
- Oncology, Colorectal Cancer, Surgery, Surgical Oncology, Obesity
- Medical subject headings
- Rectal Neoplasms, Neoplasms, Colorectal Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rectal Cancer | Rectal Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS)
Disease-free survival (DFS) was defined as the time from surgical resection to disease recurrence (including loco-regional failure or metastases) or death of any cause
Measured: 5 yers
Overall Survival (OS)
Overall survival (OS) was defined as the time interval from surgical resection to either death from any cause or last follow up
Measured: 5 years
Secondary outcomes (1)
Pathological Complete Response (CR)
Pathological CR was defined as no viable cancer cells in the excised specimen.
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 posted18 Feb 2021
- Study start21 Mar 2017
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Hussein Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Al-Masri, King Hussein Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759638
- Sponsor's protocol ID
- 17KHCC42
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Mass Index Role in the Oncological Outcome of Locally Advanced Rectal Cancer: The Two BMI Extremes as Comparative Groups, A Retrospective Study
- ClinicalTrials.gov ID
- NCT04759638
- Acronym / sponsor ID
- 17KHCC42
- Conditions
- Rectal Cancer
- Keywords
- Oncology, Colorectal Cancer, Surgery, Surgical Oncology, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- King Hussein Cancer CenterUniversity, hospital or other
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 18 Feb 2021 (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.
There is a controversy regarding the effect of the two Body Mass Index (BMI) extremes on the oncological outcome of rectal cancer.
The obesity paradox appears to exist in rectal cancer patients treated with nCRT and surgery, as it was associated with significantly higher rates of pathological complete response and R0 resection.
Underweight patients were at higher risk for anastomotic leak and R1 resection.
Detailed description
Background:
Obesity and underweight are associated with increased risk of postoperative morbidity in colorectal cancer patients undergoing surgery. There is a controversy regarding the effect of the two Body Mass Index (BMI) extremes on the oncological outcome of rectal cancer.
Objective:
The aim of this study was to evaluate the effect of BMI on short- and long-term oncological outcomes as well as postoperative complications in rectal cancer patients who received neoadjuvant chemoradiotherapy (nCRT) followed by surgery.
Setting:
Tertiary Cancer Center serving pediatric and adult patients in Jordan and the Middle East.
Patients:
The medical records of patients with stage II-III rectal cancer who received nCRT followed by surgery during 2006 to 2018 were retrospectively reviewed. The patients were subdivided according to their BMI into less than 20 kg/m2 defined as underweight; between 20 to 30 kg/m2 defined as normal range weight, above 30 kg/m2 defined as obese.
Main Outcome Measures:
Disease-Free Survival (DFS), Overall Survival, Pathological Complete Response (CR)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal Cancer | – | –Rectal Cancer |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- 294 patients included in the study
Key inclusion criteria (1 listed)
- Patients who underwent rectal surgery at King Hussein Cancer Center (KHCC) from 2006 to 2018 were identified. Those with locally advanced rectal cancer (stages II and III) who underwent nCRT followed by surgery with curative intent were included.
Key exclusion criteria (1 listed)
- Patients with early rectal cancer (stage I) who did not require nCRT and those who underwent rectal surgery as part of a staged or simultaneous approach for metastatic disease (stage IV) were excluded.
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
Disease-Free Survival (DFS)
Time frame: 5 yers
Disease-free survival (DFS) was defined as the time from surgical resection to disease recurrence (including loco-regional failure or metastases) or death of any cause
Overall Survival (OS)
Time frame: 5 years
Overall survival (OS) was defined as the time interval from surgical resection to either death from any cause or last follow up
1 secondary outcome
Pathological Complete Response (CR)
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 18 Feb 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rectal Cancer, run by King Hussein Cancer Center at 1 site in Jordan.
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 1 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 18 Feb 2021. 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 Jordan. 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?
Disease-Free Survival (DFS) (time frame: 5 yers). The study lists 2 primary outcomes in all. 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 18 Feb 2021.