Locally Advanced Rectal CarcinomaNCT06314737
Assessment of Efficacy of Neoadjuvant Therapy in Locally Advanced Rectal Cancer
An observational study of Locally Advanced Rectal Carcinoma, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
This study analyzed the efficacy differences between neoadjuvant therapy and direct surgical treatment in patients with locally advanced rectal cancer in the real world. The aim was to evaluate the impact of neoadjuvant therapy on overall survival, disease-free survival, and local recurrence-free survival in patients… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Locally Advanced Rectal Carcinoma
- How many people
- 3,515 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2010to 1 Jan 2024
- 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
- All sexes
- Child, Adult, Older adult
Study population: Patients who visited the Sixth Affiliated Hospital of Sun Yat-sen University between October 2010 and December 2018, were diagnosed with primary rectal adenocarcinoma based on initial pathological examination, and were diagnosed as T3-4 or N+ based on pelvic MRI or abdominal-pelvic CT scan. Their distance from the tumor lower margin to the anal verge was ≤12cm, and they subsequently underwent surgical treatment.
Who may be able to join
- Pathological examination confirmed primary rectal adenocarcinoma;
- Pelvic MRI or abdominal-pelvic CT at initial diagnosis diagnosed as T3-4 or N+;
- Thoracoabdominal CT indicated no evidence of distant metastasis;
- Distance from the tumor lower margin to the anal verge ≤12cm;
- Underwent surgical treatment.
Who cannot join
- Concurrently diagnosed with multiple colorectal cancers or concomitant other malignant tumors;
- Locally recurrent rectal cancer;
- Initial diagnosis suggests suspicious distant metastasis;
- Histological diagnosis of rectal squamous cell carcinoma, adenocarcinoma, or neuroendocrine carcinoma;
- MRI information lost;
- Did not undergo surgical treatment;
- Upper rectal cancer or cancer at the rectosigmoid junction.
About this study
Official title: Assessment of Efficacy of New Adjuvant Therapy in Locally Advanced Rectal Cancer
This study analyzed the efficacy differences between neoadjuvant therapy and direct surgical treatment in patients with locally advanced rectal cancer in the real world. The aim was to evaluate the impact of neoadjuvant therapy on overall survival, disease-free survival, and local recurrence-free survival in patients with locally advanced rectal cancer, explore the population benefiting most from neoadjuvant therapy, and provide evidence-based medicine for the benefits of neoadjuvant therapy in patients with colorectal cancer in the real world.
Read the detailed description
Colorectal cancer ranks third in terms of global incidence (10.2%) and second in terms of mortality (9.2%) among malignant tumors, with rectal cancer accounting for one-third of cases. The standard treatment regimen for locally advanced rectal cancer (LARC), neoadjuvant chemotherapy (NACT) combined with total mesorectal excision (TME), has been shown to better control local disease, reduce local recurrence rates, but does not improve overall survival. In recent years, with the continuous improvement of surgical techniques, surgical treatment has also achieved better local control effects for locally advanced rectal cancer. However, the efficacy of neoadjuvant therapy varies greatly in different studies. For locally advanced rectal cancer, a prospective clinical study published in the New England Journal of Medicine in 2004 compared the efficacy differences between preoperative neoadjuvant chemoradiotherapy (NCRT) and postoperative chemoradiotherapy. The study demonstrated that compared to postoperative chemoradiotherapy, preoperative NCRT combined with total mesorectal excision could better control the local disease, reduce the toxicity of chemoradiotherapy, but did not help prolong overall survival. However, due to issues such as increased postoperative complications associated with neoadjuvant radiotherapy, some rectal cancer patients refuse neoadjuvant radiotherapy. Therefore, a significant amount of research has also been devoted to proving the efficacy of neoadjuvant chemotherapy alone.
Additionally, neoadjuvant therapy can also increase the rate of sphincter preservation for low rectal cancer. However, there is still controversy over whether neoadjuvant therapy can bring survival benefits to rectal cancer patients. How to reduce overtreatment caused by neoadjuvant therapy and related toxic side effects is also a current research hotspot. This study analyzed the efficacy differences between neoadjuvant therapy and direct surgical treatment in patients with locally high-risk rectal cancer in the real world, aiming to evaluate the impact of neoadjuvant therapy on overall survival, disease-free survival, and local recurrence-free survival in patients with locally high-risk rectal cancer, explore the high-benefit population of neoadjuvant therapy, and provide evidence-based medicine evidence for the benefits of neoadjuvant therapy in real-world rectal cancer patients.
- Conditions
- Locally Advanced Rectal Carcinoma
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 |
|---|---|---|
| Neoadjuvant therapy group | The primary tumor received neoadjuvant therapy before surgical treatment. | |
| Surgical treatment group | The primary tumor did not receive neoadjuvant therapy before surgical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death from any cause.
Measured: From date of randomization until the date of death from any cause, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start2 Oct 2010
- Primary completion6 Dec 2018
- Study completion1 Jan 2024
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 Locally Advanced Rectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,515 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai Zerong, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Zerong Cai, MD, Study director, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314737
- Sponsor's protocol ID
- 2021ZSLYEC-192
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Please contact us by e-mail
Publications
Wang Z, Bai F, Chen Y, Liu X, Huang Z, Zhu Q, Wu X, Cai Z. Does the initial treatment of primary tumor impact prognosis after recurrence in locally advanced rectal cancer? Results from a retrospective cohort analysis. Int J Colorectal Dis. 2024 Sep 28;39(1):153. doi: 10.1007/s00384-024-04721-9.
PubMed 39333450
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy of New Adjuvant Therapy in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT06314737
- Acronym / sponsor ID
- 2021ZSLYEC-192
- Conditions
- Locally Advanced Rectal Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,515 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 2 Oct 2010 (actual)
- Primary completion
- 6 Dec 2018 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 18 Mar 2024 (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.
This study analyzed the efficacy differences between neoadjuvant therapy and direct surgical treatment in patients with locally advanced rectal cancer in the real world. The aim was to evaluate the impact of neoadjuvant therapy on overall survival, disease-free survival, and local recurrence-free survival in patients with locally advanced rectal cancer, explore the population benefiting most from neoadjuvant therapy, and provide evidence-based medicine for the benefits of neoadjuvant therapy in patients with colorectal cancer in the real world.
Detailed description
Colorectal cancer ranks third in terms of global incidence (10.2%) and second in terms of mortality (9.2%) among malignant tumors, with rectal cancer accounting for one-third of cases. The standard treatment regimen for locally advanced rectal cancer (LARC), neoadjuvant chemotherapy (NACT) combined with total mesorectal excision (TME), has been shown to better control local disease, reduce local recurrence rates, but does not improve overall survival. In recent years, with the continuous improvement of surgical techniques, surgical treatment has also achieved better local control effects for locally advanced rectal cancer. However, the efficacy of neoadjuvant therapy varies greatly in different studies. For locally advanced rectal cancer, a prospective clinical study published in the New England Journal of Medicine in 2004 compared the efficacy differences between preoperative neoadjuvant chemoradiotherapy (NCRT) and postoperative chemoradiotherapy. The study demonstrated that compared to postoperative chemoradiotherapy, preoperative NCRT combined with total mesorectal excision could better control the local disease, reduce the toxicity of chemoradiotherapy, but did not help prolong overall survival. However, due to issues such as increased postoperative complications associated with neoadjuvant radiotherapy, some rectal cancer patients refuse neoadjuvant radiotherapy. Therefore, a significant amount of research has also been devoted to proving the efficacy of neoadjuvant chemotherapy alone.
Additionally, neoadjuvant therapy can also increase the rate of sphincter preservation for low rectal cancer. However, there is still controversy over whether neoadjuvant therapy can bring survival benefits to rectal cancer patients. How to reduce overtreatment caused by neoadjuvant therapy and related toxic side effects is also a current research hotspot. This study analyzed the efficacy differences between neoadjuvant therapy and direct surgical treatment in patients with locally high-risk rectal cancer in the real world, aiming to evaluate the impact of neoadjuvant therapy on overall survival, disease-free survival, and local recurrence-free survival in patients with locally high-risk rectal cancer, explore the high-benefit population of neoadjuvant therapy, and provide evidence-based medicine evidence for the benefits of neoadjuvant therapy in real-world rectal cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therapy group | – | –The primary tumor received neoadjuvant therapy before surgical treatment. |
| Surgical treatment group | – | –The primary tumor did not receive neoadjuvant therapy before surgical treatment. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who visited the Sixth Affiliated Hospital of Sun Yat-sen University between October 2010 and December 2018, were diagnosed with primary rectal adenocarcinoma based on initial pathological examination, and were diagnosed as T3-4 or N+ based on pelvic MRI or abdominal-pelvic CT scan. Their distance from the tumor lower margin to the anal verge was ≤12cm, and they subsequently underwent surgical treatment.
Key inclusion criteria (5 listed)
- Pathological examination confirmed primary rectal adenocarcinoma;
- Pelvic MRI or abdominal-pelvic CT at initial diagnosis diagnosed as T3-4 or N+;
- Thoracoabdominal CT indicated no evidence of distant metastasis;
- Distance from the tumor lower margin to the anal verge ≤12cm;
- Underwent surgical treatment.
Key exclusion criteria (7 listed)
- Concurrently diagnosed with multiple colorectal cancers or concomitant other malignant tumors;
- Locally recurrent rectal cancer;
- Initial diagnosis suggests suspicious distant metastasis;
- Histological diagnosis of rectal squamous cell carcinoma, adenocarcinoma, or neuroendocrine carcinoma;
- MRI information lost;
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
Overall Survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 120 months
Overall survival is defined as the time from the date of randomization to the date of death from any cause.
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 Mar 2024.
- Derived from this study: PubMed 39333450Wang Z, Bai F, Chen Y, Liu X, Huang Z, Zhu Q, Wu X, Cai Z. Does the initial treatment of primary tumor impact prognosis after recurrence in locally advanced rectal cancer? Results from a retrospective cohort analysis. Int J Colorectal Dis. 2024 Sep 28;39(1):153. doi: 10.1007/s00384-024-04721-9.
- Individual participant dataSharing planned: No. Please contact us by e-mail
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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.
Zerong Cai, MD study director
Sixth Affiliated Hospital, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Rectal Carcinoma, run by Sixth Affiliated Hospital, Sun Yat-sen 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 5 inclusion and 7 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 Mar 2024. 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?
Overall Survival (time frame: From date of randomization until the date of death from any cause, assessed up to 120 months). 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 NCT06314737, 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 18 Mar 2024.