Neoplasms

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Digestive System Diseases

Neoplasm Metastasis

Rectal Neoplasms

Liver Neoplasms

Neoplastic Processes

Colorectal Neoplasms

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Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Capecitabine

Oxaliplatin

Liver Extracts

Antimetabolites

Induction chemotherapy - Capecitabine (1250 mg/m2 PO twice daily on D1-14 and oxaliplatin 130 mg/m2 on D1, every 3 weeks for 2 cycles) Preoperative chemoradiotherapy - Capecitabine 825 mg/m2 PO twice daily during radiotherapy and oxaliplatin 50 mg/m2/day on weekly.

Capecitabine, Oxaliplatin

Preoperative radiotherapy, 5040 cGy with 28 fractions

Radiotherapy

To investigate the feasibility of preoperative chemoradiation with oxaliplatin plus capecitabine, with or without prior induction chemotherapy in patients with locally advanced or marginally resectable rectal cancer with resectable synchronous liver metastases.

Preoperative chemoradiation is now an initial treatment of choice for locally advanced resectable rectal cancer, and 5-fluorouracil is the standard agent during chemoradiation. Capecitabine is an oral fluoropyrimidine which has been thought to be a replacement for intravenous 5-fluorouracil, and several trials have proved that preoperative chemoradiation with capecitabine was also effective in this setting.

Oxaliplatin, a newer platinum agent, plus fluoropyrimidines (either 5-fluorouracil or capecitabine) is one of the standard cytotoxic chemotherapeutic regimen for metastatic colorectal cancer, and it is also proved to be effective as neoadjuvant chemotherapy for patients with liver only metastasis from colorectal cancer.

Approximately 25% of patients with colorectal cancer have liver metastases initially at the time of diagnosis and there have been quite well established evidences for clear survival benefits from hepatic metastasectomy in these patients. Treatment for colorectal liver metastases should be planned with consideration of both systemic chemotherapy and local treatment modality (surgery or radiofrequency ablation) because long term survival would be expected after curative liver metastasectomy. As mentioned previously, neoadjuvant oxaliplatin plus fluoropyrimidines before hepatic metastasectomy improved disease-free survival, thus it is thought to be that better systemic controls would be achieved with perioperative oxaliplatin based chemotherapy.

In patients with locally advanced rectal cancer, preoperative chemoradiation with fluoropyrimidines improves local control but not systemic control. Recent randomized trials of preoperative chemoradiation with oxaliplatin plus fluoropyrimidines failed to show better local control rates than those with fluoropyrimidines alone. But it is too early to determine the non-superiority of preoperative chemoradiation with oxaliplatin plus fluoropyrimidines in terms of systemic control; long-term duration of follow-up is needed to determine the efficacy in terms of disease-free or overall survival and it is evident that oxaliplatin based chemotherapy is effective for systemic control in patients who will be candidate for liver metastasectomy.

Thus, the investigators planned a randomized phase II trial of preoperative chemoradiation with oxaliplatin plus capecitabine, with or without prior induction chemotherapy in patients with locally advanced or borderlinely resectable rectal cancer with resectable synchronous liver metastases.

Preoperative CRT With or Without Induction Chemotherapy for Rectal Cancer With Liver Metastases

Randomized Phase II Trial of Preoperative Chemoradiation With or Without Induction Chemotherapy In Patients With Locally Advanced Or Borderlinely Resectable Rectal Cancer With Resectable Synchronous Liver Metastases

Asan Medical Center

Professor

Rare Diseases

Stomach Neoplasms

Lymphatic Metastasis

Stomach Diseases

Stomach Cancer

Research subjects who were enrolled in CLASSIC trial and underwent adjuvant chemotherapy.

Research subjects who were enrolled in CLASSIC trial and did not undergo adjuvant chemotherapy

Capecitabine, oxaliplatin

The pattern of lymph node metastasis of the gastric cancer to each geographic lymph nose stations and the relation between each metastasis and survival are to be analyzed by retrospective review of medical records of who enrolled in the CLASSIC trial (NCT00411229) which have compared adjuvant chemotherapy and no adjuvant therapy after radical gastrectomy with extended lymphadenectomy.

Lymph Node Metastasis in Extended Lymphadenectomy for Gastric Cancer From a CLASSIC Trial

Pattern and Clinical Implication of Lymph Node Metastasis From Gastric Cancer Which Was Resected by Radical Surgery With Extended Lymphadenectomy

Saint Vincent's Hospital, Korea

Gachon University Gil Medical Center

Gangnam Severance Hospital

Kyungpook National University Hospital

Kyunghee University Medical Center

Keimyung University Dongsan Medical Center

Korea University Guro Hospital

Korea University Anam Hospital

Kosin University Gospel Hospital

National Cancer Center, Korea

Seoul Veterans Hospital

Seoul National University Bundang Hospital

Soonchunhyang University Hospital

Severance Hospital

Ajou University

Yeungnam University Hospital

Korea Cancer Center Hospital

Ewha Womans University Mokdong Hospital

Chonbuk National University Hospital

Chonnam National University Hospital

Seoul National University Hospital

Drug: Neoadjuvant chemotherapy Capeox (Capecitabine + Oxaliplatin), 6 cycles; adjuvant chemotherapy, Capecitabine, 2 cycles or physicians' decision.

External beam radiotherapy: Neoadjuvant, 50 Gy, 2 Gy/session; 25 fractions. Procedure: 'Watch and wait strategy' or surgery including local excision, intersphincter resection or total mesorectal excision or other kinds of surgeries.

External beam radiotherapy to the primary tumor, regional lymph nodes and clinical target volume

External beam radiotherapy

'Local excision' or 'Intersphincter resection' or 'Total mesorectal excision' or other surgeries

Surgery

Watch and wait strategy recommendation and discussion for cCR patients

Watch and wait strategy

WeiWei Xiao

This is a open-label, single-arm study to investigate the safety and efficacy of total neoadjuvant treatment (TNT) in patients with locally advanced resectable rectal cancer.

Standard treatment of rectal cancer is neoadjuvant capecitabine chemotherapy with radiotherapy, followed by total mesorectal excision.

A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life.

The rational is the fact that 15%-20% of patients have sterilized tumours after chemoradiotherpay for locally advanced rectal cancer. As compared to capecitabine alone, oxaliplatin and more intensified chemotherapy have been shown to increase tumor regression in the neoadjuvant chemoradiation setting. Meanwhile, prolong of time interval from the end of radiotherapy to assessment of tumor response could further increase pathologic complete response rate and complete clinical response rate.

The objective of this trial is to increase the rate of clinical complete response for distal rectal cancer patients by optimizing tumour response. The investigators expect to increase chance of clinical complete response by using total neoadjuvant treatment regimen as compared to conventional chemoradiotherapy alone.

TNT to Increase the Clinical Complete Response Rate for Distal LARC

Total Neoadjuvant trEatment to Increase the Clinical Complete reSponse Rate for diStal Locally Advanced Rectal Cancer (TESS)

Number of patients with sphincter preservation through Watch and wait strategy, or local excision, or intersphincter resection, or low anterior resection, etc.

Rate of pathological complete response and tumor regression grade distribution

Long-term anal function according to Wexner Continence Grading Scale

Long-term toxicity grading according to CTCAE 5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative CRT With or Without Induction Chemotherapy for Rectal Cancer With Liver Metastases	NCT01643070	Rectal Cancer Liver Metastase...	Capecitabine, O... Radiotherapy	20 Years - 75 Years	Asan Medical Center
Preoperative CRT With or Without Induction Chemotherapy for Rectal Cancer With Liver Metastases	NCT01643070	Rectal Cancer Liver Metastase...	Capecitabine, O... Radiotherapy	20 Years - 75 Years	Asan Medical Center
Lymph Node Metastasis in Extended Lymphadenectomy for Gastric Cancer From a CLASSIC Trial	NCT02298010	Stomach Neoplas... Cancer of Lymph...	Capecitabine, o...	18 Years -	Seoul National University Hospital
TNT to Increase the Clinical Complete Response Rate for Distal LARC	NCT03840239	Rectal Cancer Rectal Cancer S... Rectal Cancer S... Chemoradiation	Capecitabine, O... External beam r... Surgery Watch and wait ...	18 Years - 70 Years	Sun Yat-sen University
TNT to Increase the Clinical Complete Response Rate for Distal LARC	NCT03840239	Rectal Cancer Rectal Cancer S... Rectal Cancer S... Chemoradiation	Capecitabine, O... External beam r... Surgery Watch and wait ...	18 Years - 70 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for capecitabine, oxaliplatin