CORRECT: What the Colorectal Cancer Trial Found

The situation this trial was built for

There is a point in metastatic colorectal cancer where the standard drugs have all been tried and all stopped working. The trial's own opening line describes it: no treatment options are available once the disease progresses after every approved standard therapy, yet many people are still well enough to consider more treatment.

CORRECT asked whether regorafenib, a tablet that blocks several signalling enzymes at once, could help in exactly that gap.

How it was run

Between April 2010 and March 2011, 1,052 people were screened at 114 centers in 16 countries. Of those, 760 were randomly assigned in a 2-to-1 ratio: 505 to regorafenib, 255 to placebo. Everyone also received best supportive care, meaning treatment aimed at symptoms rather than the cancer.

Regorafenib was taken by mouth, 160 mg once a day, for the first three weeks of every four-week cycle. That was the trial's fixed schedule. Anyone prescribed regorafenib follows their own oncologist's instructions instead. Neither the participants, the investigators nor the sponsor knew who was getting the drug. The main measure was overall survival, meaning how long people lived, not how much tumors shrank.

The trial dose is given here as a record of what was tested. Your own prescription is the one to work from, because teams often start lower.

Everyone enrolled had cancer that had grown during, or within three months after, their last standard treatment. It is registered as NCT01103323.

The result, in the numbers reported

The trial was stopped at a planned interim analysis in July 2011 because the survival endpoint had been met.

Median overall survival was 6.4 months with regorafenib against 5.0 months with placebo. The hazard ratio for death was 0.77, with a 95% confidence interval of 0.64 to 0.94 and a one-sided p-value of 0.0052.

A hazard ratio of 0.77 means roughly a 23% lower risk of dying at any given moment during the trial. The difference in medians is about six weeks.

Both descriptions are true at once, and they land very differently. Our page on reading clinical trial results explains why the same result can be summarized two ways.

What it cost the people taking it

The side-effect numbers deserve equal billing. Treatment-related adverse events occurred in 465 of the 500 people who took regorafenib, which is 93%, against 154 of 253 on placebo, 61%.

The most common severe reactions, meaning grade 3 or higher, were:

• Hand-foot skin reaction: 83 people, 17%
• Fatigue: 48 people, 10%
• Diarrhea: 36 people, 7%
• High blood pressure: 36 people, 7%
• Rash or peeling skin: 29 people, 6%

Hand-foot skin reaction is painful redness, swelling and blistering on the palms and soles. At grade 3 it interferes with walking and with using your hands. Roughly one in six people on the drug had it at that level.

That combination, a median gain of about six weeks alongside frequent and unpleasant toxicity, is why CORRECT started an honest argument about what counts as benefit.

Where this sits in colorectal cancer

Colorectal cancer starts in the colon or rectum. NCI notes it is the second leading cause of cancer death in the United States when men and women are counted together, and that new cases fell between 2012 and 2021, a decline driven largely by falling rates in adults aged 65 and older.

For 2026 the American Cancer Society projects 158,850 new US cases and 55,230 deaths, and SEER republishes that projection. Five-year relative survival, which NCI measures from SEER records for people diagnosed between 2016 and 2022, is 91.3% when the cancer is still confined to the bowel wall, 75.2% once it has reached nearby lymph nodes, and 16.9% once it has spread further. Only 34% are found while still confined.

That last row is CORRECT's population, several treatment lines further on. Our page on colorectal cancer treatment covers the earlier steps.

When to get checked

Screening is the part that changes those numbers, because a polyp removed at colonoscopy never becomes a cancer. Screening starts at 45 for people at average risk. Symptoms are a separate route, at any age:

• Blood in the stool, or stools that look black or tarry
• A change in bowel habit lasting more than three weeks
• Stools that have become narrow and stay that way
• Belly pain or cramping that does not settle
• Feeling that the bowel does not empty completely
• Weight loss you cannot explain
• Fatigue, or a blood test showing iron-deficiency anemia with no clear cause

Rectal bleeding attributed to hemorrhoids is worth a second look, particularly under 50.

What this does not mean

• The absolute survival gain was a median of about six weeks. Some people gained much more, some none.
• Nearly everyone on the drug had treatment-related side effects, and severe hand-foot skin reaction affected about one in six.
• Everyone enrolled still had a good performance status. Results may not carry over to people who are more unwell.
• CORRECT tested regorafenib after every standard therapy had failed. It says nothing about earlier lines of treatment.
• Whether this drug fits any individual is a clinical decision, and declining it is a legitimate one.

Sources

• Grothey A et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 2013;381:303-12. PMID 23177514, NCBI eutils record — https://eutils.ncbi.nlm.nih.gov/entrez/eutils/efetch.fcgi?db=pubmed&id=23177514&retmode=xml
• NCI PDQ, Colorectal Cancer Prevention (Patient Version) — https://www.cancer.gov/types/colorectal/patient/colorectal-prevention-pdq
• NCI PDQ, Colon Cancer Treatment (Patient Version) — https://www.cancer.gov/types/colorectal/patient/colon-treatment-pdq
• U.S. Preventive Services Task Force, Colorectal Cancer: Screening — https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening
• SEER Cancer Stat Facts, Colorectal Cancer — https://seer.cancer.gov/statfacts/html/colorect.html

How this article was prepared

An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.

The National Cancer Information Foundation publishes Cancer Explained. This page is for learning. It is not medical advice and does not suggest a test or treatment.

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