CTV Exploration of 3D-PT Assisted CT-guided I-125 Seeds Implantation for Recurrent Rectal Cancer

NCT04710589 | Unknown

• 1 other identifier: CTV of 125I for rectal cancer
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to explore the progression-free survival time (PFS) , overall survival time (OS), quality of life and side effects between two different clinical target volumes in the treatment of 3D printing template-assisted CT-guided radioactive iodine-125 seeds implantation for recurrent rectal cancer after surgery and radiotherapy and investigate the clinical and dosimetric prognosis factors for outcomes.

Conditions

Recurrent Rectal Cancer; 125I Seeds Implantation; Clinical Target Volume

Keywords

recurrent rectal cancer; 125I seeds implantation; clinical target volume; 3D printing template; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression free survival time (PFS)

  The time from 125I radioactive seeds implantation to local failure or death.

  3 years

Secondary Outcomes (1)

• Overall survival time (OS)

  3 years

Other Outcomes (3)

• Karnosky Score

  3 years

• Visual Analogue Score

  3 years

• Side effects

  3 years

Study Arms (2)

CTV 3mm

CTV is expanded by 3mm on the basis of GTV.

CTV 6mm

CTV is expanded by 6mm on the basis of GTV.

Radiation: CTV

Interventions

CTV RADIATION

According to the clinical conditions of the patients, they will be assigned to two groups based on the doctor's recommendations and their own wishes

CTV 6mm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recurrent rectal cancer after surgery and radiotherapy who will receive 3D-PT Assisted CT-guided I-125 Seeds Implantation

You may qualify if:

• KPS score above 60;
• Age from 18 to 80 years old;
• Rectal cancer by histological diagnosis, recurrence after surgery and radiotherapy;
• The diameter of the lesion ≤ 5cm;
• The tumor has not invaded the intestines or bladder;
• The estimated survival time is more than 3 months;
• The percutaneous puncture path is feasible and the preoperative plan can meet the prescription dose;
• Blood routine, liver, kidney and other major organ functions: WBC is normal, PLT≥100×109/L, HGB≥100g/L; urea nitrogen, creatinine≤1.25×upper limit of normal (UNL), ALT (SGPT) and AST (SGOT) ≤2.5×UNL; ECG is basically normal;
• Recurrence in pelvic region after surgery and radiotherapy for various reasons; or oligo-metastatic lesions less than 3, which are stable with treatment. Except for rectal incision stump and recurrence at the anastomosis.

You may not qualify if:

• Major organ failure, decompensated heart and lung failure such as congestive heart failure, coronary heart disease with clinical symptoms, and arrhythmia that cannot be controlled by drugs;
• Patients with other serious uncontrollable medical diseases;
• Severe coagulation dysfunction;
• With serious infection or ulcer at the puncture site;
• Pregnancy, breastfeeding women, children and mental patients;
• Patients with severe diabetes;
• Cases that invade large blood vessels and vital organs, which may cause hemorrhage and severe organ dysfunction;
• Those who have participated in clinical trials of other drugs or medical devices before being selected but have not reached the time limit of the main research endpoint or have completed clinical trials of other drugs or medical devices for less than 4 weeks;
• Poor compliance and unable to complete the course of treatment;
• Other reasons the researchers think it is inappropriate to participate in this clinical trial.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking Unnversity Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Xuemin Li, Dr

CONTACT

+86-15201304917; lixueminrz@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 14, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

CN (1)