Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During Chemoradiotherapy

• Sponsor: Fudan University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05688033
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35.9
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

This project first retrospectively analyzes the intestinal dose indicators related to the concurrent radiotherapy and chemotherapy of rectal cancer and gastrointestinal toxicity, and the pelvic dose indicators related to hematological toxicity, and then prospectively conducts radiotherapy based on the dose indicators most closely related to toxicity. The dose is limited when the plan is made to reduce the gastrointestinal and hematological toxicity of rectal cancer with concurrent radiotherapy and chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Radiation: dosimetric limitation of pelvic bone and peritoneal space during radiotherapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During During Neoadjuvant Chemoradiation With Capecitabine and Irinotecan
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Aug 30, 2022
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental arm peritoneal space V15<850cc，pelvic bone V10<80% and normal dosimetric limitation	Radiation: dosimetric limitation of pelvic bone and peritoneal space during radiotherapy; dosimetric limitation of pelvic bone and peritoneal space during radiotherapy
No Intervention: control arm normal dosimetric limitation

Outcome Measures

Primary Outcome Measures

1. Number of Participants Experiencing Adverse Events [up to 3 years]

Secondary Outcome Measures

1. Number of Participants in Who Experienced Tumor Down-staging [up to 3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with rectal adenocarcinoma

2. Clinical staged T3/4 or any node-positive disease

3. Age of 18-75 years

4. Karnofsky Performance Status > 80

5. Adequate bone marrow reserve, renal and hepatic functions

6. Without previous antitumoural chemotherapy

7. No evidence of metastatic disease

8. Written informed consent before randomization

9. UGT1A1's genotype of 6/6 or 6/7

Exclusion Criteria:

1. Clinical staged I or IV

2. Age of <18 or >75 years

3. Karnofsky Performance Status < 80

4. Previous pelvis radiotherapy

5. Previous antitumoural chemotherapy

6. Clinically significant internal disease

7. Refuse to write informed consent before randomization

8. UGT1A1's genotype of 7/7

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Fudan University

Investigators

• Principal Investigator: Zhen Zhang, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhen Zhang, Professor, Fudan University
• ClinicalTrials.gov Identifier: NCT05688033
• Other Study ID Numbers: IMRTGI0001
• First Posted: Jan 18, 2023
• Last Update Posted: Jan 18, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Jan 18, 2023