KCT0007169
Recruiting
未知
Total neoadjuvant therapy with short-course radiotherapy versus long-course neoadjuvant chemoradiotherapy in locally advanced rectal cancer
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Seoul National University Hospital
- Enrollment
- 348
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Histologically diagnosed locally advanced rectal cancer (stage II/III)
- •(2\) The distal border of the tumor located \=10 cm from the anal verge
- •(3\) Men and women aged 19\-80 years
- •(4\) No evidence of distant metastasis (including paraaortic LN, common \& external iliac LN) on abdominal pelvic CT or chest CT scan
- •(5\) ECOG performance \=1 and be capable of activities for daily living
- •(6\) American Society of Anesthesiologists (ASA) Physical Status Classification System Class I\~II
- •(7\) No history of any other systemic treatment (chemotherapy, immunotherapy) or radiotherapy for rectal cancer
- •(8\) No history of intrapelvic radiotherapy
- •(9\)The following investigation criteria should be satisfied:
- •Bone marrow function: absolute neutrophils \=1,500/mm3, platelets \=75,000/mm3
Exclusion Criteria
- •(1\) Histological carcinoma other than rectal adenocarcinoma or adenocarcinoma arising from inflammatory bowel disease
- •(2\) Suspected distant metastasis
- •(3\) NCI CTC grade 1 or higher peripheral neuropathy
- •(4\) Uncontrolled or severe cardiovascular disease, myocardial infarction within 6 months, NYHA grade 3 or higher heart failure, or uncontrolled angina
- •(5\) Infection or other disease that is not currently controlled
- •(6\) History of other malignancies within 5 years (except for cured superficial skin cancer or cervical carcinoma in situ)
- •(7\) History of organ transplant requiring immunosuppressive therapy
- •(8\) Uncontrolled epilepsy or psychosis
- •(9\) Pregnant or lactating women, women of childbearing potential who do not intend to actively use contraception, or men who are planning pregnancy or do not intend to actively use contraception
- •(10\) Cases required to continue concomitant treatment expected to interact with oxaliplatin, such as flucytosine, phenytoin, or warfarin
Outcomes
Primary Outcomes
Not specified
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