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

Clinical Target Volume Exploration of 3D Printing Personalized Template Assisted CT-guided Radioactive Iodine-125 Seeds Implantation as a Salvage Treatment for Recurrent Rectal Cancer Patients After Operation and Radiotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Rectal Cancer; 125I Seeds Implantation; Clinical Target Volume
• Intervention / Treatment: Radiation: CTV

Detailed Description

From June 2019 to December 2020 in each participating center, patients with recurrent rectal cancer after surgery and radiotherapy will be included in the study if they meet the inclusion criteria and do not meet the exclusion criteria. According to the clinical conditions of the patients, they will be assigned to groups A or B according to the doctor's recommendations and their own wishes. GTV of both groups are visible tumors. The CTV of group A is expanded by 3mm on the basis of GTV, and the CTV of group B is expanded by 6mm. Both groups A and B received prescription dose: 95% GTV (120-160) Gy, 95% CTV (90-120) Gy. The activities of 125I seeds will be 0.4mCi-0.7mCi. All patients will receive 3D printed template-assisted 125I seeds implantation and be followed up. The differences in local progression-free survival time, overall survival time, change of quality of life, and side effects between different groups will be prospectively analyzed.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Xuemin Li, Dr; Phone Number: +86-15201304917; Email: lixueminrz@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking Unnversity Third Hospital
      • Contact: Xuemin Li, Dr; Phone Number: +86-15201304917; Email: lixueminrz@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival time (PFS)	The time from 125I radioactive seeds implantation to local failure or death.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival time (OS)	The time from 125I radioactive seeds implantation to death due to any cause.	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Karnosky Score	This is a functional status score, which is one of the methods to evaluate the quality of life. The range is from 0-100 points. The higher the score, the better the functional status and the higher the quality of life are.	3 years
Visual Analogue Score	This is a pain score ,which is one of the evaluation indicators of quality of life. The range is 0-10 points. The higher the score, the higher the pain and the worse the quality of life are.	3 years
Side effects	Difined and classified by RTOG	3 years

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (ACTUAL): January 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: recurrent rectal cancer; radiotherapy; 125I seeds implantation; clinical target volume; 3D printing template
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Recurrence; Rectal Neoplasms
• Other Study ID Numbers: CTV of 125I for rectal cancer

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No