Status:
UNKNOWN
NEOadjuvant Chemotherapy Only Compared With Standard Treatment for Locally Advanced Rectal Cancer
Lead Sponsor:
Zealand University Hospital
Conditions:
Colorectal Neoplasm
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main clinical hypothesis is that compared to radio-chemotherapy for low and mid rectal tumors or surgery for high rectal tumors neoadjuvant chemotherapy reduces the rate of distant relapse without...
Detailed Description
The standard treatment of locally advanced but resectable cancer in the middle or lower rectum is preoperative radio-chemotherapy and in the upper part initial surgery. The clinical benefit from radio...
Eligibility Criteria
Inclusion
- Adenocarcinoma of the rectum with the lower boarder within 15 cm from the anal verge
- Locally advanced tumor based on imaging
- T3 tumors within 10 cm from the anal verge fulfilling the criteria for preoperative radio-chemotherapy according to Danish Colorectal Cancer Group (DCCG) guidelines
- T3c or T4 tumors 10-15 cm from the anal verge
- Deemed resectable at the multidisciplinary team (MDT) conference
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Age at least 18 years
- Adequate bone marrow, liver and renal function allowing systemic chemotherapy
- Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l.
- Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value
- Calculated or measured renal glomerular filtration rate at least 30 mL/min
- Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable
- Written and orally informed consent
Exclusion
- Distant metastasis
- Invasive ingrowth into other organs
- Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy
- Previous radiotherapy to the pelvis
- Previous treatment with 5FU or oxaliplatin
- Surgery within two weeks
- Neuropathy NCI grade \> 1
- Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri
- Pregnant (positive pregnancy test) or breast feeding women
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT03280407
Start Date
March 1 2017
End Date
December 31 2024
Last Update
September 28 2017
Active Locations (1)
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1
Vejle Hospital
Vejle, Denmark