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Anti-cancer agent

Pre-Surgery Chemotherapy for Rectal Cancer

Phase < 1
Waitlist Available
Led By George Chang
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Nodal involvement confined to the radiation field
Histologically confirmed diagnosis of rectal adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing how well active surveillance (monitoring cancer growth after treatment) and chemotherapy before surgery work in treating stage II-III rectal cancer.

Who is the study for?
This trial is for adults with stage II-III rectal cancer who can undergo standard chemotherapy and are fit enough for potential surgery. They must have measurable disease, be able to use contraception if needed, and provide consent. Excluded are those with bowel obstruction, inability to undergo MRI, certain genetic cancer types like MSI-H, prior pelvic radiation or active treatment for other cancers.Check my eligibility
What is being tested?
The study tests the effectiveness of monitoring tumor growth (active surveillance) combined with pre-surgery chemotherapy in treating rectal cancer patients. It aims to determine if delaying surgery after these treatments leads to better outcomes compared to immediate surgery.See study design
What are the potential side effects?
Chemotherapy may cause side effects such as nausea, vomiting, hair loss, fatigue, increased risk of infection due to lowered blood cell counts and potential damage to healthy cells alongside the tumor cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread only to lymph nodes that can be targeted by radiation.
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My diagnosis is rectal cancer confirmed by tissue examination.
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My cancer can be measured or seen on scans.
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My rectal cancer can be surgically removed with the goal of curing it.
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I have no known allergies or reactions to standard pelvic chemoradiation treatments.
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My cancer is at Stage II or III, and it's been checked with specific scans.
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I can care for myself and am up and about more than 50% of my waking hours.
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My rectal tumor is within 12 cm of the anal opening, confirmed by a scan or endoscopy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Local tumor regrowth rate
Overall organ preservation rate
Time to surgery or death
Secondary outcome measures
Decision quality assessment determined by European Organization for Treatment and Research of Cancer Quality of Life Questionnaire (EORTC-QLQ30+CR29)
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Overall survival (OS)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (active surveillance)Experimental Treatment4 Interventions
Participants who have achieved clinical complete response receive active surveillance and consolidated chemotherapy for up to 4 months in the absence of disease progression or unacceptable toxicity. Participants with incomplete response or regrowth of tumor, undergo surgical resection as in Group I.
Group II: Group I (surgical resection)Active Control2 Interventions
Participants who have achieved clinical complete response undergo standard surgical resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,526 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,329 Total Patients Enrolled
George ChangPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials

Media Library

Chemotherapy (Anti-cancer agent) Clinical Trial Eligibility Overview. Trial Name: NCT03594630 — Phase < 1
Rectal Cancer Research Study Groups: Group II (active surveillance), Group I (surgical resection)
Rectal Cancer Clinical Trial 2023: Chemotherapy Highlights & Side Effects. Trial Name: NCT03594630 — Phase < 1
Chemotherapy (Anti-cancer agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03594630 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please provide information about the enrollment status of this research endeavor?

"Unfortunately, this clinical trial is not presently enlisting for patient participation. The original posting was made on October 31st 2022 and the last update occurred September 22nd 2022; however, there are 311 other trials actively recruiting at present."

Answered by AI
~80 spots leftby Oct 2026