surgery for Cancer of Rectum

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cancer of Rectum+1 More
surgery - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at whether a different combination of chemotherapy drugs (FOLFOX) and selective use of radiation therapy is better than the standard 5FUCMT treatment for locally advanced rectal cancer.

Eligible Conditions
  • Cancer of Rectum
  • Colorectal Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: Up to 8 years

Up to 8 years
Adverse event (AE) profiles
DFS (Phase III)
Overall survival
Pathologic complete response
Pelvic R0 resection rate (Phase II)
Rates of receiving pre- or post-operative 5FUCMT
Time to local recurrence (TLR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Group 2
1 of 2
Group 1
1 of 2
Active Control
Experimental Treatment

1194 Total Participants · 2 Treatment Groups

Primary Treatment: surgery · No Placebo Group · Phase 2 & 3

Group 1Experimental Group · 4 Interventions: magnetic resonance imaging or endorectal ultrasound, FOLFOX (chemotherapy), surgery, 5 FUCMT (chemoradiation) · Intervention Types: Procedure, Drug, Procedure, Other
Group 2ActiveComparator Group · 3 Interventions: FOLFOX (chemotherapy), surgery, 5 FUCMT (chemoradiation) · Intervention Types: Drug, Procedure, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
surgery
2005
Completed Phase 4
~6970

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 8 years

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
497 Previous Clinical Trials
213,482 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
112 Previous Clinical Trials
63,597 Total Patients Enrolled
National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,297,694 Total Patients Enrolled
1 Trials studying Cancer of Rectum
500 Patients Enrolled for Cancer of Rectum
Deborah Schrag, MDStudy ChairDana-Farber Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, CT or PET/CT scan of the chest/abdomen/pelvis and either a pelvic MRI or an ultrasound (ERUS).
You have four or more lymph nodes that are ≥ 10 mm.
You have a diagnosis of rectal adenocarcinoma.
Radiologically measurable or clinically evaluable disease as defined in the protocol.
For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined modality neoadjuvant chemoradiation followed by curative intent surgical resection.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Arizona100.0%
How old are they?
65+100.0%
What site did they apply to?
Mayo Clinic Hospital100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%