This trial is to assess the efficacy and feasibility of consolidation chemotherapy after neoadjuvant chemoradiotherapy for locally advanced mid or low rectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
358
5-FU, Leucovorin, and Oxaliplatin (FOLFOX regimen)
Inje University Busan Paik hospital
Busan, South Korea
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea
Pathologic complete response
Pathologic complete response is defined as no residual tumor on the surgical specimen after chemoradiotherapy. (i.e. Mandard grade 1 or Dworak grade 4)
Time frame: 2 years
Disease-free survival
The rates of patients who survive without recurrence
Time frame: 3 years
Radiotherapy-related complications
Complications according to the CTCAE 4.0
Time frame: 2 years
R0 resection
R0 resection is defined as resection without remnant tumor, whereas R1 resection as microscopic residual tumor and R2 resection as gross residual tumor. R0 resection will be proven histologically as no resection margin involvement of tumor.
Time frame: 2 years
Tumor response rate
Amount of tumor regression after surgery according to the guideline including Mandard or Dworak
Time frame: 2 years
Postoperative complications
Complications after surgery
Time frame: 2 years
Peripheral neuropathy
Peripheral neuropathy will be evaluated as grade 1 to 4 according to NCI CTCAE 4.0.
Time frame: 3 years
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Chuncheon Sacred Heart Hospital, Hallym University College of Medicine
Chuncheon, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Wonkwang University Hospital
Iksan, South Korea
Inje University Sanggye Paik Hospital
Seoul, South Korea
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
Seoul St. Mary's Hospital, The Catholic University College of Medicine
Seoul, South Korea
...and 4 more locations