Rectal NeoplasmsNCT03601689
Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma
An observational study of Rectal Neoplasms, run by Moroccan Society of Surgery at 8 sites in 2 countries.
Trial summary
Many data suggest that patients with low rectal adenocarcinoma who achieved ypT0N0 status have improved survival and disease-free survival (DFS) compared to all other stages however only few data are available regarding the specific prognosis factors of this subgroup. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- rectal resection
- Type of treatment
- Surgery or procedure
- How many people
- 84 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Jan 2005to 31 Mar 2016
- 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: All consecutive patients who underwent neoadjuvant treatment followed by total mesorectal excision for rectal adenocarcinoma in 8 centers
Who may be able to join
- patients with a histologically proven low rectal adenocarcinoma,
- no previous or synchronous colorectal disease,
- UICC stage I-III patients who underwent neoadjuvant chemoradiotherapy or chemotherapy,
- followed by total mesorectal excision (TME), and
- a complete pathological response defined as ypT0N0
Who cannot join
- all patients with metastatic tumors or missing data
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Morocco7 sites
Sidi Mohammed Ben Abdellah University Medical School, Surgery Department,
Fes
Mohammed Ist University Medical School, Surgical Oncology, Hospital el Farabi
Oujda
Mohammed V University Medical School, Surgery Department, Military Hospital
Rabat, Please Enter the State Or Province, 10001
Mohammed V University Medical School, Surgical Department "A", Ibn Sina Hospital
Rabat, Please Enter the State Or Province, 10001
Mohammed V University Medical School, Surgical Department "C", Ibn Sina Hospital,
Rabat, Please Enter the State Or Province, 10001
National Institut of Oncology, Surgical oncology department
Rabat, Please Enter the State Or Province, 10001
Private surgical oncology center
Salé
About this study
Many data suggest that patients with low rectal adenocarcinoma who achieved ypT0N0 status have improved survival and disease-free survival (DFS) compared to all other stages however only few data are available regarding the specific prognosis factors of this subgroup. This retrospective multicentric study aimed to predict the prognosis of patients with complete pathological response after neoadjuvant treatment.
- Conditions
- Rectal Neoplasms
- Being tested
- rectal resection
- Keywords
- Low rectal cancer, Neoadjuvant treatment, Complete pathological response, ypT0N0, disease free survival, Predictive factors
- Medical subject headings
- Rectal Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectal resectionProcedure or surgery
total mesorectal excision
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence rate
A postoperative local recurrence was defined by biopsy-proven or radiographic evidence of local recurrent disease.
Measured: From date of surgery until the date of first documented local progression assessed up to 100 months
Distant recurrence rate
A postoperative distant recurrence was defined by biopsy-proven or radiographic evidence of distant recurrent disease.
Measured: From date of surgery until the date of first documented distant progression assessed up to 100 months
Secondary outcomes (1)
Predictive factors of disease free survival
Disease free survival was defined as the period between the day of surgery and the date of recurrence or the last date of follow-up
Measured: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jan 2005
- Primary completion31 Dec 2013
- Study completion31 Mar 2016
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 Rectal NeoplasmsStudies 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moroccan Society of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601689
- Sponsor's protocol ID
- CompleteResponse
- Status last verified
- Jul 2018
- First submitted
- 14 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Souadka A, Majbar MA, Benkabbou A, Serji B, Souiki T, Bouchentouf SM, Abid M, El Khannousi B, El Harroudi T, El Malki HO, Raiss M, Ifrine L, Mazaz K, Zentar A, Mohsine R, Souadka A, Belkouchi A, Ahallat M, Hrora A; Moroccan Society of Surgery. Predictive factors of disease-free survival after complete pathological response to neoadjuvant radiotherapy for rectal adenocarcinoma: retrospective case series. BMC Cancer. 2019 Oct 28;19(1):1008. doi: 10.1186/s12885-019-6239-3.
PubMed 31660903
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03601689
- Acronym / sponsor ID
- CompleteResponse
- Conditions
- Rectal Neoplasms
- Keywords
- Low rectal cancer, Neoadjuvant treatment, Complete pathological response, ypT0N0, disease free survival, Predictive factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Moroccan Society of SurgeryUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 26 Jul 2018 (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.
Many data suggest that patients with low rectal adenocarcinoma who achieved ypT0N0 status have improved survival and disease-free survival (DFS) compared to all other stages however only few data are available regarding the specific prognosis factors of this subgroup. This retrospective multicentric study aimed to predict the prognosis of patients with complete pathological response after neoadjuvant treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who underwent neoadjuvant treatment followed by total mesorectal excision for rectal adenocarcinoma in 8 centers
Key inclusion criteria (5 listed)
- patients with a histologically proven low rectal adenocarcinoma,
- no previous or synchronous colorectal disease,
- UICC stage I-III patients who underwent neoadjuvant chemoradiotherapy or chemotherapy,
- followed by total mesorectal excision (TME), and
- a complete pathological response defined as ypT0N0
Key exclusion criteria (1 listed)
- all patients with metastatic tumors or missing data
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 |
|---|---|---|
| rectal resectiontotal mesorectal excision | Procedure or surgery | – |
Primary outcome
Local recurrence rate
Time frame: From date of surgery until the date of first documented local progression assessed up to 100 months
A postoperative local recurrence was defined by biopsy-proven or radiographic evidence of local recurrent disease.
Distant recurrence rate
Time frame: From date of surgery until the date of first documented distant progression assessed up to 100 months
A postoperative distant recurrence was defined by biopsy-proven or radiographic evidence of distant recurrent disease.
1 secondary outcome
Predictive factors of disease free survival
Time frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 26 Jul 2018.
- Derived from this study: PubMed 31660903Souadka A, Majbar MA, Benkabbou A, Serji B, Souiki T, Bouchentouf SM, Abid M, El Khannousi B, El Harroudi T, El Malki HO, Raiss M, Ifrine L, Mazaz K, Zentar A, Mohsine R, Souadka A, Belkouchi A, Ahallat M, Hrora A; Moroccan Society of Surgery. Predictive factors of disease-free survival after complete pathological response to neoadjuvant radiotherapy for rectal adenocarcinoma: retrospective case series. BMC Cancer. 2019 Oct 28;19(1):1008. doi: 10.1186/s12885-019-6239-3.
- Individual participant dataSharing planned: Undecided
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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.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasms, run by Moroccan Society of Surgery at 8 sites in 2 countries.
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 5 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Morocco, Algeria. 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?
Local recurrence rate (time frame: From date of surgery until the date of first documented local progression assessed up to 100 months). 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?
On the ClinicalTrials.gov record for NCT03601689, 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 26 Jul 2018.