Study on Pre-Operative Therapy and Surgery for Rectal Cancer: The RAPIDO Trial
Sponsor: University Medical Center Groningen
ClinicalTrials ID:NCT01558921
This clinical trial is exploring a new approach to treating locally advanced rectal cancer by comparing a shorter pre-operative therapy with the standard treatment. The goal is to see if this new method can improve survival rates by effectively treating the tumor and any potential spread of cancer.
Patient Parameters
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Program Overview
The RAPIDO trial is investigating whether a new treatment plan can improve outcomes for patients with locally advanced rectal cancer. Currently, about half of these patients remain disease-free for three years after treatment. The standard approach involves long-term radiation and chemotherapy before surgery, but this hasn't improved overall survival rates. The new method being tested involves a short course of radiation followed by chemotherapy before surgery. This approach aims to treat the tumor and any small cancer spread while the patient is in good health to handle chemotherapy. Researchers believe this could lead to better survival rates compared to the standard treatment.
Description
In this study, patients with rectal cancer will be randomly assigned to one of two groups. The experimental group will receive a short course of radiation therapy over five days, followed by six cycles of chemotherapy (using capecitabine/5FU and oxaliplatin) before undergoing surgery. The control group will receive the standard long course of chemoradiotherapy before surgery. After surgery, additional chemotherapy may be given based on the hospital's protocol. In both groups, the cancerous rectal tumor will be surgically removed, and more extensive surgery may be performed if needed due to the tumor's size.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed with rectal adenocarcinoma confirmed by lab tests.
- Tumor is locally advanced and meets at least one high-risk criterion on an MRI scan, such as:
- Tumor growing into nearby organs or structures.
- Tumor involving the peritoneum or showing signs of spreading through blood vessels.
- Four or more lymph nodes showing signs of cancer.
- Tumor or lymph node very close to the mesorectal fascia.
- Enlarged lateral lymph nodes over 1 cm.
Exclusion Criteria
- Tumor growth into the upper sacrum or nerve roots, making surgery impossible.
- Presence of metastatic disease or recurrent rectal cancer.
- Genetic conditions like Familial Adenomatosis Polyposis coli (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC), or active inflammatory bowel diseases.
- Other cancers, except for certain skin or cervical cancers, unless disease-free for 5 years.
- Known deficiency in DPD enzyme.
- Conditions preventing MRI scans, like having a pacemaker.
- Medical or psychiatric conditions affecting consent ability.
- Uncontrolled medical conditions.
- Recent investigational treatment for rectal cancer.
- Pregnancy or breastfeeding.
- Malabsorption syndromes or issues with the upper gastrointestinal tract.
- Significant heart disease or recent heart attack.
- Symptoms or history of nerve damage.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Siteman Cancer Center, Washington University Medical School | 63110 | St Louis | Missouri |
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