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Prospective, multi-center, one-arm, exploratory study of preoperative chemoradiotherapy for locally advanced upper rectal and Rectal sigmoid junction adenocarcinoma

Prospective, multi-center, one-arm, exploratory study of preoperative chemoradiotherapy for locally advanced upper rectal and Rectal sigmoid junction adenocarcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029170
Enrollment
Unknown
Registered
2020-01-17
Start date
2020-01-06
Completion date
Unknown
Last updated
2020-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal and Rectal sigmoid junction adenocarcinoma

Interventions

Case series:neoadjuvant sequential therapy

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-75 years; 2. ASA anesthesia grade I to III; 3. pathologically confirmed adenocarcinoma; 4. the lower margin of the tumor was 12cm or more from the anal margin and the upper segment of the rectum was located at the junction of straight b (MRI or pelvic CT images were located 5cm above and below the upper margin of the promontory of the sacrum and the symphysis pubis in sagittal position); 5. the clinical stage was cT4bNanyM0/ cT3-4aN2m0, or EMVI (+), or the maximum diameter of the tumor >=5cm; 6. patients who have not received radiotherapy, chemotherapy and surgery; 7. liver, kidney and other organs of patients function well, and patients can withstand radiotherapy and chemotherapy and surgery; 8. the patients and their families can understand the study plan and participate in the study voluntarily, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. patients with multiple primary colorectal cancer; 2. patients with a history of other malignant tumors in the past 5 years (excluding cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer or surgically excised breast ductal carcinoma in situ); 3. patients complicated with intestinal perforation, gastrointestinal bleeding, and unrelieved intestinal obstruction (except those who have undergone rerourostomy or have been placed with intestinal stent to remove the obstruction) need emergency surgery; 4. patients with severe infection; 5. pregnant or nursing women; 6. have a history of serious mental illness; 7.participated in other clinical researchers for nearly 3 months; 8.those who have contraindications of chemoradiotherapy or surgical treatment; 9. any other circumstances deemed inappropriate for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
CAP;

Secondary

MeasureTime frame
Incidence of adverse events during radiotherapy/chemotherapy;CRM and safe margin of distal clearance;Perioperative complication rate;3-year disease free survival;

Countries

China

Contacts

Public ContactWu Bin

Peking Union Medical College Hospital

wubin@hotmail.com+86 13611188969

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026