Locally Recurrent Rectal CancerNCT06617052
Preoperative (Chemo)Radiotherapy for Locally Recurrent Rectal Cancer
An observational study of Locally Recurrent Rectal Cancer and Preoperative Chemoradiotherapy, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Through an observational study, the efficacy and safety of preoperative chemoradiotherapy followed by surgery in patients with recurrent rectal cancer were assessed. The primary population included patients with (potentially) resectable locally recurrent rectal cancer, excluding those with distant metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Recurrent Rectal Cancer, Preoperative Chemoradiotherapy
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Adult, Older adult
Study population: locally recurrent rectal cancer
Who may be able to join
- Age between 18 and 75 years
- ECOG performance status of 0-1
- Histologically, cytologically, or MRI/contrast-enhanced CT confirmed pelvic recurrence. At least one measurable pelvic lesion according to RECIST 1.1
- No distant metastases outside the pelvis
- (Potentially) resectable lesion
- No history of radiotherapy within the 6 months prior to enrollment
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- No prior chemotherapy; or received postoperative adjuvant therapy but not systemic chemotherapy for metastatic lesions
- Investigator-assessed life expectancy of at least 24 weeks
- Adequate organ function (bone marrow, liver, kidney, and coagulation function) demonstrated within 7 days prior to the first dose, without the use of blood products or hematopoietic growth factors
- Not pregnant or breastfeeding. Effective contraception must be used during the study and for 6 months after the last dose
- Fully informed and willing to provide written informed consent to participate in the trial
Who cannot join
- Severe electrolyte abnormalities
- Active coronary artery disease, severe/unstable angina, newly diagnosed angina, or myocardial infarction within 12 months prior to study participation Thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, or deep vein thrombosis within the past 6 months
- New York Heart Association (NYHA) class II or higher congestive heart failure
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); untreated active hepatitis (hepatitis B defined as HBV-DNA ≥ 500 IU/ml, or hepatitis C defined as HCV-RNA above the detection limit of the assay) or co-infection with hepatitis B and C
- Active inflammatory bowel disease or other colorectal diseases causing chronic diarrhea
- Any active, known, or suspected autoimmune disease. Stable conditions not required systemic immunosuppressive therapy are allowed, such as type I diabetes, hypothyroidism requiring only hormone replacement therapy, and skin conditions (e.g., vitiligo, psoriasis, and alopecia) not requiring systemic treatment
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- Interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, or acute pneumonia)
- Known or suspected history of allergy to any study-related medications
- Clinically detectable second primary malignancy or history of another malignancy within the past 5 years
- Pregnant or breastfeeding women, or women with a positive pregnancy test before the first dose, or female participants and their partners unwilling to use strict contraception during the study
- Any clinical or laboratory abnormalities or compliance issues that the investigator deems unsuitable for study participation
- Severe psychiatric disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510065
Yikan Cheng, 15102033641, chengyk3@mail.sysu.edu.cn
About this study
Official title: Efficacy and Safety of Preoperative (Chemo)Radiotherapy for Locally Recurrent Rectal Cancer: A Prospective, Single-arm Observational Study
Through an observational study, the efficacy and safety of preoperative chemoradiotherapy followed by surgery in patients with recurrent rectal cancer were assessed. The primary population included patients with (potentially) resectable locally recurrent rectal cancer, excluding those with distant metastases. The study design was a prospective, open-label, single-arm observational study. The primary endpoint was the pCR (pathological complete response) rate, while secondary endpoints included R0 resection rate, local recurrence-free survival, overall survival, and safety.
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response
The resected tumor tissue and regional lymph nodes were pathologically assessed, revealing no residual tumor cells. The tumor lesions had completely disappeared, and no new lesions were detected.
Measured: up to 26 weeks
Secondary outcomes (3)
R0 rates
The complete tumor resection rate is defined as the absence of cancer cells at the resection margins under a microscope, with no visible or microscopic residual cancer cells, indicating that the lesion has been entirely removed.
Measured: up to 26 weeks
progression-free survival
The interval between the start of enrollment and local recurrence, progression of local recurrence, distant metastasis, or death.
Measured: 5 years
overall survival
The interval between the start of enrollment and death.
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 posted27 Sep 2024
- Study start19 Sep 2024 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Recurrent Rectal CancerStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617052
- Sponsor's protocol ID
- 2024ZSLYEC-487
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Preoperative (Chemo)Radiotherapy for Locally Recurrent Rectal Cancer: A Prospective, Single-arm Observational Study
- ClinicalTrials.gov ID
- NCT06617052
- Acronym / sponsor ID
- 2024ZSLYEC-487
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 19 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Sep 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.
Through an observational study, the efficacy and safety of preoperative chemoradiotherapy followed by surgery in patients with recurrent rectal cancer were assessed. The primary population included patients with (potentially) resectable locally recurrent rectal cancer, excluding those with distant metastases. The study design was a prospective, open-label, single-arm observational study. The primary endpoint was the pCR (pathological complete response) rate, while secondary endpoints included R0 resection rate, local recurrence-free survival, overall survival, and safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- locally recurrent rectal cancer
Key inclusion criteria (11 listed)
- Age between 18 and 75 years
- ECOG performance status of 0-1
- Histologically, cytologically, or MRI/contrast-enhanced CT confirmed pelvic recurrence. At least one measurable pelvic lesion according to RECIST 1.1
- No distant metastases outside the pelvis
- (Potentially) resectable lesion
Key exclusion criteria (12 listed)
- Severe electrolyte abnormalities
- Active coronary artery disease, severe/unstable angina, newly diagnosed angina, or myocardial infarction within 12 months prior to study participation Thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, or deep vein thrombosis within the past 6 months
- New York Heart Association (NYHA) class II or higher congestive heart failure
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); untreated active hepatitis (hepatitis B defined as HBV-DNA ≥ 500 IU/ml, or hepatitis C defined as HCV-RNA above the detection limit of the assay) or co-infection with hepatitis B and C
- Active inflammatory bowel disease or other colorectal diseases causing chronic diarrhea
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
pathologic complete response
Time frame: up to 26 weeks
The resected tumor tissue and regional lymph nodes were pathologically assessed, revealing no residual tumor cells. The tumor lesions had completely disappeared, and no new lesions were detected.
3 secondary outcomes
R0 rates
Time frame: up to 26 weeks
progression-free survival
Time frame: 5 years
overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
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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.
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 Locally Recurrent Rectal Cancer and Preoperative Chemoradiotherapy, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 11 inclusion and 12 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: opening soon, as of the sponsor's last update on 27 Sep 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YI-KAN CHENG Yi-kan Cheng (15102033641, chengyk3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response (time frame: up to 26 weeks). 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 27 Sep 2024.