General SurgeryNCT06713824
Neoadjuvant Radiotherapy Before Surgery for Rectal Cancer, Surgical and Oncological Outcome Analysis, Retrospective Case Control Study in a Single Institute.
An observational study of General Surgery and Radiology, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Pre-operative radiotherapy for clinical stage 3 rectal cancer outcome analysis, retrospective case-control study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- General Surgery, Radiology
- How many people
- 1,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2017to 30 Nov 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study collected clinical stage 3 rectal cancer patients who underwent radical resection without neoadjuvant radiotherapy at Taichung Veterans General Hospital from January 1, 2017 to October 1, 2024.
Who may be able to join
- Rectal cancer, clinical stage T3 or higher, with no distant metastasis.
- Age > =20 years, ASA class I-III.
- Underwent surgery.
- Complete medical records.
Who cannot join
- Non-rectal cancer.
- Clinical stage T1-T2.
- Stage IV with distant metastasis.
- Age < 20 years, ASA class IV-V.
- Incomplete medical records.
- HIV-positive patients (Human Immunodeficiency Virus).
- Patients who completed treatment after October 1, 2024.
Trial locations and contacts
1 site in 1 country.
About this study
Pre-operative radiotherapy for clinical stage 3 rectal cancer outcome analysis, retrospective case-control study.
Read the detailed description
For clinical T3 rectal cancer, neo-adjuvant radiotherapy was proved to reduce local recurrent rate in the clinical trials. In this study, we analysis surgical and oncological outcomes of neo-adjuvant radiotherapy for stage 3 rectal cancer in the real world in a single institute and do further subgroups analysis as references for treatment plans.
- Conditions
- General Surgery, Radiology
- Keywords
- neo-adjuvant, rectal cancer, radiotherapy, concurrent chemo-radiation therapy
- Medical subject headings
- Rectal Neoplasms
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 |
|---|---|---|
| neo-adjuvant radiotherapy and surgery | receive radiation therapy before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
The disease recurrence rate refers to the likelihood of a disease reappearing after initial treatment, encompassing both local recurrence and distant metastasis.
Local recurrence is defined by medical standards as the reappearance of a tumor at the original site or nearby lymph nodes, typically confirmed through imaging or pathological examination and commonly occurring within 1-3 years post-surgery.
Distant metastasis, on the other hand, is identified when tumor cells spread to distant organs, such as the liver, lungs, or bones, and is confirmed through imaging modalities (e.g., CT, MRI, or PET scans) or biopsy. The incidence of distant metastasis is closely related to tumor staging, such as the TNM classification.
Measured: 5-year postoperative period
survival rate
This refers to the percentage of patients who are alive at a certain point in time after treatment, often 5 years, from diagnosis or start of treatment. The 5-year survival rate is commonly used in cancer research.
Measured: 5-year postoperative period
Secondary outcomes (2)
Complication rate
Complications are common during post-operative treatment. Complication rate is the proportion of patients who experience an adverse event or secondary health problem as a result of the disease or the treatment provided. Some common complications include intestinal obstruction, wound infection, pneumonia, anastomotic fistula, chylous leak, and urinary tract infection (UTI).
Measured: 30 days after surgery
Complications of radiation and chemotherapy
Radiation and chemotherapy are essential cancer treatments but come with potential complications. Common radiation-related complications include skin reactions, fatigue, nausea, pulmonary toxicity, and bowel/bladder issues. Chemotherapy can lead to myelosuppression, nausea, alopecia, mucositis, and neuropathy. Measures to manage these complications include supportive care, prophylactic medications (e.g., antiemetics, growth factors), and close monitoring. Standards such as the CTCAE and Clavien-Dindo classification are used to assess and report the severity of adverse events. Personalized treatment plans, early intervention, and patient education are key to minimizing risks and improving patient outcomes.
Measured: 30 days after radiation and chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Jan 2017
- Primary completion1 Oct 2024
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General SurgeryStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713824
- Sponsor's protocol ID
- CE24540A
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 3 Dec 2024
- 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 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Radiotherapy Before Surgery for Rectal Cancer, Surgical and Oncological Outcome Analysis, Retrospective Case Control Study in a Single Institute.
- ClinicalTrials.gov ID
- NCT06713824
- Acronym / sponsor ID
- CE24540A
- Conditions
- General Surgery, Radiology
- Keywords
- neo-adjuvant, rectal cancer, radiotherapy, concurrent chemo-radiation therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 3 Dec 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.
Pre-operative radiotherapy for clinical stage 3 rectal cancer outcome analysis, retrospective case-control study.
Detailed description
For clinical T3 rectal cancer, neo-adjuvant radiotherapy was proved to reduce local recurrent rate in the clinical trials. In this study, we analysis surgical and oncological outcomes of neo-adjuvant radiotherapy for stage 3 rectal cancer in the real world in a single institute and do further subgroups analysis as references for treatment plans.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neo-adjuvant radiotherapy and surgery | – | –receive radiation therapy before surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study collected clinical stage 3 rectal cancer patients who underwent radical resection without neoadjuvant radiotherapy at Taichung Veterans General Hospital from January 1, 2017 to October 1, 2024.
Key inclusion criteria (4 listed)
- Rectal cancer, clinical stage T3 or higher, with no distant metastasis.
- Age > =20 years, ASA class I-III.
- Underwent surgery.
- Complete medical records.
Key exclusion criteria (7 listed)
- Non-rectal cancer.
- Clinical stage T1-T2.
- Stage IV with distant metastasis.
- Age < 20 years, ASA class IV-V.
- Incomplete medical records.
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
Recurrence rate
Time frame: 5-year postoperative period
The disease recurrence rate refers to the likelihood of a disease reappearing after initial treatment, encompassing both local recurrence and distant metastasis. Local recurrence is defined by medical standards as the reappearance of a tumor at the original site or nearby lymph nodes, typically confirmed through imaging or pathological examination and commonly occurring within 1-3 years post-surgery. Distant metastasis, on the other hand, is identified when tumor cells spread to distant organs, such as the liver, lungs, or bones, and is confirmed through imaging modalities (e.g., CT, MRI, or PET scans) or biopsy. The incidence of distant metastasis is closely related to tumor staging, such as the TNM classification.
survival rate
Time frame: 5-year postoperative period
This refers to the percentage of patients who are alive at a certain point in time after treatment, often 5 years, from diagnosis or start of treatment. The 5-year survival rate is commonly used in cancer research.
2 secondary outcomes
Complication rate
Time frame: 30 days after surgery
Complications of radiation and chemotherapy
Time frame: 30 days after radiation and chemotherapy
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 3 Dec 2024.
Related trials for General Surgery
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
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 General Surgery and Radiology, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 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 Taiwan. 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?
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?
Recurrence rate (time frame: 5-year postoperative period). 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?
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 3 Dec 2024.