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Clinical Trial NCT06566222 for Radiotherapy is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Chemoradiotherapy After Surgery Versus Preoperative Chemoradiotherapy for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors 2,000 Observational Overall Survival
Clinical Trial NCT06566222 is an observational study for Radiotherapy and is currently not yet recruiting. Enrollment is planned to begin on 25 August 2024 and continue until the study accrues 2,000 participants. Led by Changhai Hospital, this study is expected to complete by 31 December 2024. The latest data from ClinicalTrials.gov was last updated on 22 August 2024.
Brief 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
Official Title
Chemoradiotherapy After Surgery Versus Preoperative Chemoradiotherapy for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors
Conditions
RadiotherapyOther Study IDs
- ChanghaiH-Radiotherapy
NCT ID Number
Start Date (Actual)
2024-08-25
Last Update Posted
2024-08-22
Completion Date (Estimated)
2024-12-31
Enrollment (Estimated)
2,000
Study Type
Observational
Status
Not yet recruiting
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
NAT+High | High-risk Factors High-risk Factors vs low-risk Factors |
NAT+Low | N/A |
PAT+High | chemoradiotherapy after surgery chemoradiotherapy after surgery vs preoperative chemoradiotherapy High-risk Factors High-risk Factors vs low-risk Factors |
PAT+Low | N/A |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall survival | 2024 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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
(4) 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
- 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
Changhai HospitalNo contact data.