Neoadjuvant ChemoradiotherapyNCT04013347
Outcomes of Resection at Different Times Between the End of Neoadjuvant Treatment and Surgery
An observational study of Neoadjuvant Chemoradiotherapy and Rectal Tumor, run by Campus Bio-Medico University.
Trial summary
Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal tumours. Ideal time interval between the end of NRCT and surgery is still debated; a 6-8 weeks time interval is considered optimal, but shorter or longer intervals have been associated with better oncological outcomes. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Neoadjuvant Chemoradiotherapy, Rectal Tumor, Surgery
- What is being tested?
- Rectal Resection
- Type of treatment
- Surgery or procedure
- How many people
- 167 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 21 Mar 2017
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: One hundred and sixty-seven patients with rectal adenocarcinoma who underwent to resection after combined NRCT at University Campus Bio-Medico di Roma from January 2005 to March 2015 were retrospectively analysed.
Who may be able to join
- patients with rectal adenocarcinoma who underwent to resection after combined NRCT at University Campus Bio-Medico di Roma from January 2005 to March 2015.
- To evaluate the anastomotic dehiscence were excluded patients undergone to Abdomino-perineal resection (APR) and 4 patients for whom data were not available.
Who cannot join
None listed.
About this study
Official title: Evaluation of Anatomopathological, Oncological and Surgical Outcomes in Relation to the Different Times Between the End of Neoadjuvant Treatment and Surgery
Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal tumours. Ideal time interval between the end of NRCT and surgery is still debated; a 6-8 weeks time interval is considered optimal, but shorter or longer intervals have been associated with better oncological outcomes. Moreover, there is a lack of data about clinical postoperative outcomes and different time intervals after the end of NRCT. Here, effect that different time intervals have on postoperative complications with particular regard to the anastomotic dehiscence have been evaluated.
Methods One hundred-sixty-seven patients underwent surgery after long-course NRCT. Three different time intervals were considered: (0-42; 43-56; >57 days).
Read the detailed description
Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal adenocarcinoma. Even though a 6-8 weeks' time interval after the end of NRCT and surgery is considered ideal, the optimal time for surgery is still controversial.
- Being tested
- Rectal Resection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal ResectionProcedure or surgery
Low Anterior Resection and Abdominoperineal Resection
| Study group | Role | What they receive |
|---|---|---|
| Early Surgery | Surgery after ≤ 42 days from the end of neoadjuvant radio-chemotherapy Receives: Procedure: Rectal Resection | |
| Late Surgery | Surgery after 43-56 days from the end of neoadjuvant radio-chemotherapy Receives: Procedure: Rectal Resection | |
| Very Late Surgery | Surgery after 57 or more days from the end of neoadjuvant radio-chemotherapy Receives: Procedure: Rectal Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patient with low tumor regression grade
rate of low tumor regression grade (1-2)
Measured: 1 week after surgery
number of patient with surgical complications
rate of surgical complications
Measured: 1 month after surgery
Secondary outcomes (1)
number of patient with anastomotic dehiscence
rate of anastomotic dehiscence
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Jan 2005
- Primary completion1 Mar 2015
- Study completion21 Mar 2017
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 Neoadjuvant ChemoradiotherapyStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo La Vaccara, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013347
- Sponsor's protocol ID
- 08/17 OSS ComEt CBM
- Status last verified
- Jul 2019
- First submitted
- 28 Jun 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caputo D, Angeletti S, Fiore M, Ciccozzi M, Coppola A, Cartillone M, La Vaccara V, Spagnolo G, Trodella L, Coppola R. Delayed surgery after radio-chemotherapy for rectal adenocarcinoma is protective for anastomotic dehiscence: a single-center observational retrospective cohort study. Updates Surg. 2020 Jun;72(2):469-475. doi: 10.1007/s13304-020-00770-1. Epub 2020 Apr 18.
PubMed 32306273
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anatomopathological, Oncological and Surgical Outcomes in Relation to the Different Times Between the End of Neoadjuvant Treatment and Surgery
- ClinicalTrials.gov ID
- NCT04013347
- Acronym / sponsor ID
- 08/17 OSS ComEt CBM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 1 Mar 2015 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 9 Jul 2019 (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.
Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal tumours. Ideal time interval between the end of NRCT and surgery is still debated; a 6-8 weeks time interval is considered optimal, but shorter or longer intervals have been associated with better oncological outcomes. Moreover, there is a lack of data about clinical postoperative outcomes and different time intervals after the end of NRCT. Here, effect that different time intervals have on postoperative complications with particular regard to the anastomotic dehiscence have been evaluated.
Methods One hundred-sixty-seven patients underwent surgery after long-course NRCT. Three different time intervals were considered: (0-42; 43-56; >57 days).
Detailed description
Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal adenocarcinoma. Even though a 6-8 weeks' time interval after the end of NRCT and surgery is considered ideal, the optimal time for surgery is still controversial.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Surgery | – | Procedure: Rectal ResectionSurgery after ≤ 42 days from the end of neoadjuvant radio-chemotherapy |
| Late Surgery | – | Procedure: Rectal ResectionSurgery after 43-56 days from the end of neoadjuvant radio-chemotherapy |
| Very Late Surgery | – | Procedure: Rectal ResectionSurgery after 57 or more days from the end of neoadjuvant radio-chemotherapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred and sixty-seven patients with rectal adenocarcinoma who underwent to resection after combined NRCT at University Campus Bio-Medico di Roma from January 2005 to March 2015 were retrospectively analysed.
Key inclusion criteria (2 listed)
- patients with rectal adenocarcinoma who underwent to resection after combined NRCT at University Campus Bio-Medico di Roma from January 2005 to March 2015.
- To evaluate the anastomotic dehiscence were excluded patients undergone to Abdomino-perineal resection (APR) and 4 patients for whom data were not available.
Key exclusion criteria (0 listed)
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 ResectionLow Anterior Resection and Abdominoperineal Resection | Procedure or surgery | Early Surgery, Late Surgery, Very Late Surgery |
Primary outcome
number of patient with low tumor regression grade
Time frame: 1 week after surgery
rate of low tumor regression grade (1-2)
number of patient with surgical complications
Time frame: 1 month after surgery
rate of surgical complications
1 secondary outcome
number of patient with anastomotic dehiscence
Time frame: 1 month after surgery
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 9 Jul 2019.
- Derived from this study: PubMed 32306273Caputo D, Angeletti S, Fiore M, Ciccozzi M, Coppola A, Cartillone M, La Vaccara V, Spagnolo G, Trodella L, Coppola R. Delayed surgery after radio-chemotherapy for rectal adenocarcinoma is protective for anastomotic dehiscence: a single-center observational retrospective cohort study. Updates Surg. 2020 Jun;72(2):469-475. doi: 10.1007/s13304-020-00770-1. Epub 2020 Apr 18.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoadjuvant Chemoradiotherapy and Rectal Tumor, run by Campus Bio-Medico University.
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 2 inclusion and 0 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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
number of patient with low tumor regression grade (time frame: 1 week after surgery). 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 NCT04013347, 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 9 Jul 2019.