A Phase 3 interventional study of Chemotherapy in Rectal Cancer, sponsored by Kyung Hee University Hospital at Gangdong. Active, not recruiting at 14 sites in Korea, Republic of. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Kyung Hee University Hospital at Gangdong · Phase 3, Interventional, and Treatment
This trial is to assess the efficacy and feasibility of consolidation chemotherapy after neoadjuvant chemoradiotherapy for locally advanced mid or low rectal cancer.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 358 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Kyung Hee University Hospital at Gangdong is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Locally advanced rectal cancer confirmed by image (i.e. Magnetic resonance image)
Exclusion Criteria:
After neoadjuvant chemoradiotherapy, patients will receive surgery followed by eight cycles of chemotherapy.
Drug: Chemotherapy
After neoadjuvant chemoradiotherapy, patients will receive three cycles of chemotherapy. Thereafter, they will receive surgery followed by five cycles of chemotherapy.
Drug: Chemotherapy
5-FU, Leucovorin, and Oxaliplatin (FOLFOX regimen)
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
Plan to share: No
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kyung Hee University Hospital at Gangdong