RadiotherapyNCT06566222
Chemoradiotherapy After Surgery Versus Preoperative Chemoradiotherapy for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors
An observational study of Radiotherapy, run by Changhai Hospital.
Trial summary
The purpose of this observational study is to understand the effect of different timing of chemoradiotherapy on overall survival in patients with stage II/III low- and medium-level rectal cancer with or without high-risk factors Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Radiotherapy
- What is being tested?
- chemoradiotherapy after surgery and High-risk Factors
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2024to 31 Dec 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with low- and medium-level rectal cancer treated with chemoradiotherapy and surgery
Who may be able to join
- The patient is between 18 and 80 years old;
- Adenocarcinoma confirmed by pathology;
- Colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal margin is ≤10cm;
- ECOG score ≤2
- Imaging diagnostic analysis was cT1-3NxM0; (for Phase II/III) (5) CT examination of the chest and abdomen and pelvis showed no evidence of metastasis (6) Patients undergoing chemoradiotherapy and surgery
Who cannot join
- History of malignant tumors in the past;
- Diagnosis of simultaneous multiple primary colorectal cancer or other cancers;
- History of chemotherapy or radiotherapy prior to this trial
- Those with contraindications to laparoscopic surgery, such as severe cardiopulmonary insufficiency;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery;
- Pregnant or lactating women;
- Evidence of distant metastases prior to surgery
- T4b tumors were found to invade the uterus, vagina, bladder, seminal vesicles, prostate, bone, and pelvic plexus
About this study
The purpose of this observational study is to understand the effect of different timing of chemoradiotherapy on overall survival in patients with stage II/III low- and medium-level rectal cancer with or without high-risk factors
- Conditions
- Radiotherapy
- Being tested
- chemoradiotherapy after surgery, High-risk Factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemoradiotherapy after surgeryProcedure or surgery
Also called preoperative chemoradiotherapy
chemoradiotherapy after surgery vs preoperative chemoradiotherapy
High-risk FactorsOther
Also called low-risk Factors
High-risk Factors vs low-risk Factors
| Study group | Role | What they receive |
|---|---|---|
| NAT+High | Not described Receives: Other: High-risk Factors | |
| NAT+Low | Not described | |
| PAT+High | Not described Receives: Procedure: chemoradiotherapy after surgery; Other: High-risk Factors | |
| PAT+Low | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start25 Aug 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566222
- Sponsor's protocol ID
- ChanghaiH-Radiotherapy
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 22 Aug 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 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoradiotherapy After Surgery Versus Preoperative Chemoradiotherapy for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors
- ClinicalTrials.gov ID
- NCT06566222
- Acronym / sponsor ID
- ChanghaiH-Radiotherapy
- Conditions
- Radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 25 Aug 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Aug 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.
The purpose of this observational study is to understand the effect of different timing of chemoradiotherapy on overall survival in patients with stage II/III low- and medium-level rectal cancer with or without high-risk factors
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NAT+High | – | Other: High-risk Factors |
| NAT+Low | – | – |
| PAT+High | – | Procedure: chemoradiotherapy after surgery, Other: High-risk Factors |
| PAT+Low | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with low- and medium-level rectal cancer treated with chemoradiotherapy and surgery
Key inclusion criteria (5 listed)
- The patient is between 18 and 80 years old;
- Adenocarcinoma confirmed by pathology;
- Colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal margin is ≤10cm;
- ECOG score ≤2
- Imaging diagnostic analysis was cT1-3NxM0; (for Phase II/III) (5) CT examination of the chest and abdomen and pelvis showed no evidence of metastasis (6) Patients undergoing chemoradiotherapy and surgery
Key exclusion criteria (8 listed)
- History of malignant tumors in the past;
- Diagnosis of simultaneous multiple primary colorectal cancer or other cancers;
- History of chemotherapy or radiotherapy prior to this trial
- Those with contraindications to laparoscopic surgery, such as severe cardiopulmonary insufficiency;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery;
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 |
|---|---|---|
| chemoradiotherapy after surgeryAlso: preoperative chemoradiotherapychemoradiotherapy after surgery vs preoperative chemoradiotherapy | Procedure or surgery | PAT+High |
| High-risk FactorsAlso: low-risk FactorsHigh-risk Factors vs low-risk Factors | Other | NAT+High, PAT+High |
Primary outcome
Overall survival
Time frame: 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 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. 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 Radiotherapy, run by Changhai Hospital.
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 8 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: status not confirmed, as of the sponsor's last update on 22 Aug 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?
Results are not available in the source record.
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: 2024). 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 22 Aug 2024.