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Trial Title:
Chemoradiotherapy After Surgery Versus Preoperative Chemoradiotherapy for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors
NCT ID:
NCT06566222
Condition:
Radiotherapy
Conditions: Official terms:
Rectal Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
chemoradiotherapy after surgery
Description:
chemoradiotherapy after surgery vs preoperative chemoradiotherapy
Arm group label:
PAT+High
Other name:
preoperative chemoradiotherapy
Intervention type:
Other
Intervention name:
High-risk Factors
Description:
High-risk Factors vs low-risk Factors
Arm group label:
NAT+High
Arm group label:
PAT+High
Other name:
low-risk Factors
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
Criteria for eligibility:
Study pop:
Patients with low- and medium-level rectal cancer treated with chemoradiotherapy and
surgery
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. The patient is between 18 and 80 years old;
2. Adenocarcinoma confirmed by pathology;
3. Colonoscopy or imaging examination confirmed that the distance between the lower
edge of the tumor and the anal margin is ≤10cm;
4. 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
Exclusion Criteria:
1. History of malignant tumors in the past;
2. Diagnosis of simultaneous multiple primary colorectal cancer or other cancers;
3. History of chemotherapy or radiotherapy prior to this trial
4. Those with contraindications to laparoscopic surgery, such as severe cardiopulmonary
insufficiency;
5. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding,
etc., requiring emergency surgery;
6. Pregnant or lactating women;
7. Evidence of distant metastases prior to surgery
8. T4b tumors were found to invade the uterus, vagina, bladder, seminal vesicles,
prostate, bone, and pelvic plexus
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
August 25, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06566222
