Cancer of RectumNCT04456283
Survival of Patients With a Reduction in the Number of Lymph Nodes in Rectal Cancer After Neoadjuvant Chemoradiotherapy
An observational study of Cancer of Rectum and Lymph Node Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Objective: To analyze the survival of patients with a reduction in the number of resected LN in patients submitted to neoadjuvant and total excision of the mesorectum with rectal cancer. Expected results: Survival rate between patients Complete Pathologic Response with less than 12 LN and 12 or more LN. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer of Rectum, Lymph Node Disease
- What is being tested?
- Survival
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteBrazil
- Study dates
- 20 May 2019to 15 Jul 2021
- How long will I take part?
- 5 Years
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients with mid and low rectal cancer within 10 cm from the anal verge, stage cT3-4N0M0 or cT (any)N + M0
Inclusion Criteria: Patients with a biopsy-proven mid and low rectal adenocarcinoma located within 10 cm from the anal verge, stage cT3-4N0M0 or cT (any)N + M0, and patients with low (< 5 cm from anal verge) cT2N0 of distal rectum because of the risk of needing an abdominoperineal resection.
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Exclusion Criteria: Patients with synchronous colorectal cancer or other non-colorectal cancers, stage IV disease, rectal cancer in the setting of inflammatory bowel disease or familial adenomatous polyposis, palliative resections, previous pelvic radiotherapy, significant comorbidities that prevent curative surgical resection and/or CRT, concurrent participation in another research protocol involving therapeutic intervention
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Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Medicine School, Sao Paulo University
São Paulo, 05403-900
Leonardo A Bustamante, Surgeon, 55 11 985000091, leo708@hotmail.com
Leonardo A Bustamante L, MD
About this study
Official title: Prospective Analysis of the Survival of Patients With a Reduction in the Number of Lymph Nodes in Rectal Cancer After Neoadjuvant Chemoradiotherapy
Objective: To analyze the survival of patients with a reduction in the number of resected LN in patients submitted to neoadjuvant and total excision of the mesorectum with rectal cancer.
Expected results:
Survival rate between patients Complete Pathologic Response with less than 12 LN and 12 or more LN.
To determine the difference in survival between patients with less than 12 LN in complete versus incomplete response.
Read the detailed description
According to the International Union Against Cancer a minimum of 12 lymph nodes (LN) should be obtained in the surgical specimen for colorectal cancer staging. Recent studies have reported that the use of neoadjuvant chemoradiotherapy (QRN) may result in failure to obtain the minimum number of LN in the piece in 30-52% of patients. Objective: To analyze the survival of patients with a reduction in the number of resected LN in patients submitted to neoadjuvant and total excision of the mesorectum with rectal cancer. Patients and methods: From January 2013 to January 2015, patients with rectal cancer were submitted to QRN (5-FU and 5040 Gys) followed by total excision of mesorectum with ligation of the inferior mesenteric vessels in their roots. Patients with T3, T4 and / or N + staging that were up to 10 cm from the anal border were included. Patients whose treatment with neoadjuvant chemoradiotherapy was incomplete or who had significant delays in re- staging and / or performing the surgery were excluded. All were staged by rectal examination, colonoscopy, chest and abdominal CT, and pelvic MRI, and also re-staged 8 weeks after neoadjuvant termination, operated and submitted to total excision of the mesorectum. The patients were divided into 4 groups: a) Incomplete pathological response with less than 12 LN. b) Incomplete pathological response with 12 or more LN. c) Complete pathological response with less than 12 LN. d) Complete pathological response with 12 or more LN. The possible variables related to the number of LN obtained and related to general and disease free survival were studied.
Expected results:
To analyze the survival rate between patients Complete Pathologic Response with less than 12 LN and 12 or more LN. To determine the difference in survival between patients with less than 12 LN in complete versus incomplete response. Demonstrate that patients with complete pathologic response and less than 12 LN have a disease-free survival equal to or better than patients with 12 LN or more.
- Conditions
- Cancer of Rectum, Lymph Node Disease
- Being tested
- Survival
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurvivalBehavioural
5 year survival after Chemoradiation theraphy for Rectal Cancer
| Study group | Role | What they receive |
|---|---|---|
| Incomplete pathological response with less than 12 LN. | Patients with incomplete pathological response after Chemoradiation theraphy for Rectal Cancer and less than 12 lymph nodes Receives: Behavioral: Survival | |
| Incomplete pathological response with 12 or more LN. | Patients with incomplete pathological response after Chemoradiation theraphy for Rectal Cancer and 12 lymph or more nodes Receives: Behavioral: Survival | |
| Complete pathological response with less than 12 LN. | Patients with complete pathological response after Chemoradiation theraphy for Rectal Cancer and less than 12 lymph nodes Receives: Behavioral: Survival | |
| Complete pathological response with 12 or more LN. | Patients with complete pathological response after Chemoradiation theraphy for Rectal Cancer and 12 lymph or more nodes Receives: Behavioral: Survival |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 years Survival
5 years Survival
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 posted2 Jul 2020
- Study start20 May 2019
- Primary completion15 May 2020
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of RectumStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- SERGIO CARLOS NAHAS, CAIO SERGIO NAHAS, Ivan Cecconello, Ulysses Ribeiro Junior
- Responsible party
- Principal investigator, Leonardo Alfonso Bustamante, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456283
- Sponsor's protocol ID
- 9076078
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of the Survival of Patients With a Reduction in the Number of Lymph Nodes in Rectal Cancer After Neoadjuvant Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT04456283
- Acronym / sponsor ID
- 9076078
- Conditions
- Cancer of Rectum, Lymph Node Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- SERGIO CARLOS NAHAS, CAIO SERGIO NAHAS, Ivan Cecconello, Ulysses Ribeiro Junior
- Study start
- 20 May 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 2 Jul 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.
Objective: To analyze the survival of patients with a reduction in the number of resected LN in patients submitted to neoadjuvant and total excision of the mesorectum with rectal cancer.
Expected results:
Survival rate between patients Complete Pathologic Response with less than 12 LN and 12 or more LN.
To determine the difference in survival between patients with less than 12 LN in complete versus incomplete response.
Detailed description
According to the International Union Against Cancer a minimum of 12 lymph nodes (LN) should be obtained in the surgical specimen for colorectal cancer staging. Recent studies have reported that the use of neoadjuvant chemoradiotherapy (QRN) may result in failure to obtain the minimum number of LN in the piece in 30-52% of patients. Objective: To analyze the survival of patients with a reduction in the number of resected LN in patients submitted to neoadjuvant and total excision of the mesorectum with rectal cancer. Patients and methods: From January 2013 to January 2015, patients with rectal cancer were submitted to QRN (5-FU and 5040 Gys) followed by total excision of mesorectum with ligation of the inferior mesenteric vessels in their roots. Patients with T3, T4 and / or N + staging that were up to 10 cm from the anal border were included. Patients whose treatment with neoadjuvant chemoradiotherapy was incomplete or who had significant delays in re- staging and / or performing the surgery were excluded. All were staged by rectal examination, colonoscopy, chest and abdominal CT, and pelvic MRI, and also re-staged 8 weeks after neoadjuvant termination, operated and submitted to total excision of the mesorectum. The patients were divided into 4 groups: a) Incomplete pathological response with less than 12 LN. b) Incomplete pathological response with 12 or more LN. c) Complete pathological response with less than 12 LN. d) Complete pathological response with 12 or more LN. The possible variables related to the number of LN obtained and related to general and disease free survival were studied.
Expected results:
To analyze the survival rate between patients Complete Pathologic Response with less than 12 LN and 12 or more LN. To determine the difference in survival between patients with less than 12 LN in complete versus incomplete response. Demonstrate that patients with complete pathologic response and less than 12 LN have a disease-free survival equal to or better than patients with 12 LN or more.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Incomplete pathological response with less than 12 LN. | – | Behavioral: SurvivalPatients with incomplete pathological response after Chemoradiation theraphy for Rectal Cancer and less than 12 lymph nodes |
| Incomplete pathological response with 12 or more LN. | – | Behavioral: SurvivalPatients with incomplete pathological response after Chemoradiation theraphy for Rectal Cancer and 12 lymph or more nodes |
| Complete pathological response with less than 12 LN. | – | Behavioral: SurvivalPatients with complete pathological response after Chemoradiation theraphy for Rectal Cancer and less than 12 lymph nodes |
| Complete pathological response with 12 or more LN. | – | Behavioral: SurvivalPatients with complete pathological response after Chemoradiation theraphy for Rectal Cancer and 12 lymph or more nodes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with mid and low rectal cancer within 10 cm from the anal verge, stage cT3-4N0M0 or cT (any)N + M0
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 |
|---|---|---|
| Survival5 year survival after Chemoradiation theraphy for Rectal Cancer | Behavioural | Complete pathological response with 12 or more LN., Complete pathological response with less than 12 LN., Incomplete pathological response with 12 or more LN., Incomplete pathological response with less than 12 LN. |
Primary outcome
5 years Survival
Time frame: 5 years
5 years Survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
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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.
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 Cancer of Rectum and Lymph Node Disease, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 2 Jul 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 years Survival (time frame: 5 years). 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 2 Jul 2020.