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Antibody therapy aims to keep colon cancer from returning

NCT ID NCT00002968

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase III trial tested whether adding a monoclonal antibody called edrecolomab to surgery helps people with stage II colon cancer live longer or stay cancer-free longer. About 2,100 participants were randomly assigned to receive either the antibody or no additional treatment after surgery. The study tracked survival and how long it took for the cancer to come back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
edrecolomab (monoclonal antibody 17-1A)
What this could lead to
If successful, this could provide an additional treatment option to reduce the risk of cancer returning after surgery for stage II colon cancer.
What could go wrong
This trial is completed but results may not show a clear benefit over surgery alone. Monoclonal antibodies can cause infusion reactions or allergic responses.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2,100 people

The number who actually took part.

Start date

May 1997

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pathologic documentation of adenocarcinoma of the colon with or without penetration of the serosa with no lymph node metastases (Stage II pT3N0 or pT4bNO lesions, excluding pT4aN0; Modified Astler-Coller Stage B2); there can be no distant metastases or penetration of adjacent organs or structures; proximal, distal, and radial margins must be free of tumor Important note: A tumor nodule \> 3 mm in diameter in the perirectal or pericolonic adipose tissue without histologic evidence of residual node in the nodule is classified as regional/pericolonic node metastasis; however, a tumor nodule =\< 3 mm in diameter is classified in the T category as discontinuous extension (i.e., pT3); multiple metastatic foci seen microscopically only in the pericolonic fat should be considered as metastasis in a single lymph node for classification; although six or more nodes evaluated from the specimen is optimal, a minimum of three nodes (periodic or mesenteric) for evaluation is required for inclusion in the study * Complete, en bloc resection of all the primary tumor, performed as an open procedure, and not laparoscopically or laparoscopically assisted * No evidence of perforation or clinical obstruction of the bowel * The gross distal margin of the primary tumor must lie above the peritoneal reflection (i.e., it must be a colon, not a rectal cancer) * No previous radiation or chemotherapy for this malignancy * CALGB Performance status 0-1 * No concurrent treatment with systemic steroids is allowed; patients receiving replacement steroids for adrenal insufficiency are eligible; patients receiving inhaled steroids in daily doses of 500mg or less and patients being treated with topical steroids are eligible * No prior exposure to murine antibodies (e.g., diagnostic tests like the "oncoscint scan") * No uncontrolled or severe cardiovascular disease * No history of pancreatitis * Non-pregnant and non-lactating; patients of child-bearing potential should agree to use an effective method of birth control * No previous or concurrent malignancy is allowed, except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer if the patient has been disease-free for \>= 5 years; patients with more than one synchronous primary colon tumor are eligible; for the purpose of this protocol, staging classification will be based on the stage of the more advanced primary tumor * Granulocytes \> 1,800/μl * Platelet count \> 100,000/μl * BUN \< 1.5 x normal * Creatinine \< 1.5 x normal * Bilirubin \< 1.5 x normal

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cancer and Leukemia Group B

    Chicago, Illinois, 60606, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.