This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?
This study is being done to find out if this approach is better or worse than the usual approach for early rectal cancer. The usual approach is defined as care most people get for early rectal cancer. The usual approach for patients who are not in a study is surgery to remove the rectum or treatment with chemotherapy and radiation therapy, followed by surgery. There are several chemotherapy drugs approved by Health Canada that are commonly used with radiation therapy. For patients who get the usual approach for this cancer, about 90 out of 100 are free of cancer after 5 years. If a patient decides to take part in this study, they will either get a combination of chemotherapy drugs called FOLFOX or CAPOX for up to 12 weeks or will get chemotherapy with radiation therapy for up to 6 weeks. After finishing treatment, and even if treatment is stopped early, the study doctor will watch for side effects and determine which type of surgery would be best. After surgery, patients will be asked to come in every 4 months for 2 years, then every 6 months for an additional year. Then will be checked every year for 2 years. This means seeing the study doctor for up to 5 years after surgery. Patients may be seen more often if your study doctor thinks it is necessary.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
400 mg/m2
85 mg/m2 or 130 mg/m2 on day 1
bolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2
Clinical response rate upon re-staging
Time frame: 6 years
Quality of Life defined using the LARS score
Time frame: 6 years
Total Mesorectal Excision (TME) Free Survival
Defined as time from randomization to the time of TME attempt or performance, local recurrence after complete clinical response (cCR), or death from any cause
Time frame: 6 years
Disease Free Survival
Defined as time from randomization to local recurrence/regrowth after cCR that cannot be salvaged with an R0 TM, M1 recurrence, or death
Time frame: 6 years
Overall Survival
Among patients treated with induction chemotherapy versus chemoradiotherapy
Time frame: 6 years
Rate of downstaging to ypTO/1N0/X
Time frame: 6 years
Bowel function assessed by Low Anterior Resection Syndrome (LARS) Score
Time frame: 6 years
Bladder function assessed by EORTC QLQ-CR29 urinary frequency and urinary incontinence subscales
Time frame: 6 years
Other QoL functions assessed by subscales of FIQL
Time frame: 6 years
Other QoL functions assessed by subscales of EORTC QLQ-C30
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1,000 mg/m2 twice daily for 14 days
54 Gy (27-30 fractions)
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
RECRUITINGUCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
RECRUITINGLos Angeles General Medical Center
Los Angeles, California, United States
RECRUITINGUSC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGUC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
RECRUITINGMission Hope Medical Oncology - Santa Maria
Santa Maria, California, United States
RECRUITINGBeebe South Coastal Health Campus
Millville, Delaware, United States
RECRUITINGHelen F Graham Cancer Center
Newark, Delaware, United States
RECRUITINGMedical Oncology Hematology Consultants PA
Newark, Delaware, United States
RECRUITINGBeebe Health Campus
Rehoboth Beach, Delaware, United States
RECRUITING...and 103 more locations
Time frame: 6 years
Other QoL functions assessed by subscales of subscales of EORTC QLQ-CR29
Time frame: 6 years
Number and severity of adverse events utilizing CTCAE v5.0
Time frame: 6 years
Validate the magnetic resonance tumour regression grade (MR-TRG) in patients with T1-T3a rectal cancer
Time frame: 6 years