Intensity-Modulated Radiation Therapy for Rectal Cancer

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, CA
Rectal Cancer+9 More ConditionsIntensity-Modulated Radiation Therapy - Radiation
All Sexes

Study Summary

This trial is testing how well radiation therapy and chemotherapy work together to treat rectal cancer.

Eligible Conditions
  • Rectal Cancer
  • Stage IIA Rectal Cancer
  • Stage II Rectal Cancer
  • Stage IIIB Rectal Cancer
  • Stage IIB Rectal Cancer
  • Stage IIIC Rectal Cancer
  • Stage III Rectal Cancer
  • Stage IIIA Rectal Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 5 years

At 1 year
Anorectal function
Health-related quality of life
Local recurrence-free survival
Progression-free survival
Up to 5 years
Complete clinical response rate
Incidence of adverse events
Prediction of complete clinical response rate status by radiomics
Signatera's residual disease test

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1 Treatment Group

Treatment (IMRT, mFOLFOX6, CapeOX, TME)
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Intensity-Modulated Radiation Therapy · No Placebo Group · Phase 1

Treatment (IMRT, mFOLFOX6, CapeOX, TME)Experimental Group · 8 Interventions: Fluorouracil, Intensity-Modulated Radiation Therapy, Oxaliplatin, Capecitabine, Leucovorin, Quality-of-Life Assessment, Surveillance, Total Mesorectal Excision · Intervention Types: Drug, Radiation, Drug, Drug, Drug, Other, Behavioral, Procedure
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
Intensity-Modulated Radiation Therapy
Completed Phase 3
FDA approved
FDA approved
FDA approved
Completed Phase 3
Total Mesorectal Excision
Completed Phase 3

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Natera, Inc.Industry Sponsor
46 Previous Clinical Trials
45,194 Total Patients Enrolled
Jonsson Comprehensive Cancer CenterLead Sponsor
342 Previous Clinical Trials
20,702 Total Patients Enrolled
The Joseph Drown FoundationUNKNOWN
Ann RaldowPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The tumor can be removed by surgery.

Frequently Asked Questions

In which conditions is Intensity-Modulated Radiation Therapy usually applied?

"Intensity-Modulated Radiation Therapy is customarily employed in rectal carcinoma treatment, but can also be utilized to treat metastatic colorectal carcinoma, pancreatic endocrine carcinoma, and advanced esophageal cancers." - Anonymous Online Contributor

Unverified Answer

What potential risks can be associated with Intensity-Modulated Radiation Therapy?

"As this is an early-stage Phase 1 trial, our team at Power assigned Intensity-Modulated Radiation Therapy a score of 1 on the safety scale—lowest because there is limited evidence for its efficacy and safety." - Anonymous Online Contributor

Unverified Answer

What is the scope of participants in this investigation?

"Affirmative. Per the information available on, this medical study is actively recruiting participants with its initial post date of February 11th 2021 and latest update occurring on January 13th 2022. The trial requires 25 patients from 1 site to complete enrollment." - Anonymous Online Contributor

Unverified Answer

Has Intensity-Modulated Radiation Therapy undergone any other clinical testing prior to this?

"Currently, 726 trials are taking place to investigate the efficacy of Intensity-Modulated Radiation Therapy. Of these studies, 249 have reached Phase 3. In regards to location, while the majority of clinical research is being conducted in Guangzhou, Guangdong province, 29794 sites worldwide are running IMRT based experiments." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities to join this experiment at present?

"Affirmative. The clinical trials website lists that this experiment is recruiting as of now - it was initially posted on February 11th 2021 and updated most recently on January 13rd 2022. 25 individuals are needed for the study at one medical facility." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.