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Anti-cancer agent

Pre-Surgery Chemotherapy for Rectal Cancer

Phase < 1

Recruiting

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

Must not have

Other invasive malignancy undergoing active treatment. Patients receiving prior treatment that precludes standard chemoradiation or ability to receive consolidation/adjuvant chemotherapy will be excluded from survival analyses

Any prior pelvic radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently receiving treatment for another cancer that would interfere with this trial's treatment.

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I have had radiation therapy to my pelvic area before.

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I cannot or do not want to have a pelvic MRI.

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My colorectal cancer is MSI-H.

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My rectal cancer has come back.

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I have been diagnosed with inflammatory bowel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Local tumor regrowth rate

Overall organ preservation rate

Time to surgery or death

Secondary study objectives

Decision quality assessment determined by European Organization for Treatment and Research of Cancer Quality of Life Questionnaire (EORTC-QLQ30+CR29)

Overall survival (OS)

Pathologic Findings

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 13Eligibility criteria met