Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Stomach Neoplasms

Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Quality of Life

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Central Nervous System Stimulants

Herbal and Botanical

Fluorouracil

Viscum album peptide

Doxifluridine

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

European Mistletoe

oral chemotherapy with the 5-FU prodrug doxifluridine

oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection

subcutaneous injections thrice weekly with 1 ml in 4 increasing doses

mistletoe extract

600 - 900 mg per day orally, depending on weight and status of the patient

doxifluridine

Byung-Sik Kim, Professor

Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.

RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients

Prospective Controlled Randomized Comparative Study About Quality of Life (QoL), Immunomodulation and Safety of Adjuvant Mistletoe Treatment in Patients With Gastric Carcinoma Receiving Chemotherapy After Operation

EORTC Quality of Life Questionnaires:

1. QLQ-C30
2. QLQ-STO22

1. cytokine levels (TNF-alpha and interleukin-2)
2. lymphocyte subsets (CD 16+/CD56+ and CD 19+)

1. differential blood count
2. liver functions tests
3. adverse events

Abnoba Gmbh

Adenocarcinoma

Cisplatin

Mitomycins

Mitomycin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

Mf: Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)

iceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxifluridine 460-600mg/m2/day per oral(started at 4 weeks after surgery and administered a total of 12 months) Cisplatin 60mg/m2 intravenously monthly for 6 months (started at 4 weeks after surgery)

Mf: Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)

iceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxifluridine 460-600mg/m2/day per oral(started at 4 weeks after surgery and administered a total of 12 months) Cisplatin 60mg/m2 intravenously monthly for 6 months (started at 4 weeks after surgery)

cisplatin, mitomycin-C, doxifluridine

Yoon-Koo Kang, M.D.,Ph.D.

This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine in resected advanced gastric cancer.

Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized trials investigating the role of adjuvant chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still controversial and varied between Western and Asian trials. Meta-analysis of Western trials didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected gastric cancer compared to no treatment.

This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.

Trial of Adjuvant Chemotherapy for Gastric Cancer

A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Gastric Adenocarcinoma: Mitomycin and Doxifluridine Versus Intraperitoneal Chemotherapy and Mitomycin, Doxifluridine, and Cisplatin

Because safety profile in oncology study is evaluated for each toxicity, it is impossible to present the overall patient number. Instead, we presented the number of patients who declined study therapy due to adverse events or patient will.

Ulsan University Hospital

Hallym University Medical Center

Asan Medical Center

Professor

Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)

Mitomycin and Short-term Fluoropyrimidine

Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine

iceMFP

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Korea, Republic of

Region of Enrollment

Dr. Yoon-Koo Kang

Mitomycin and short-term flouropyrimidine

Relapse-free Survival

Toxicity Profile (According to NCI CTC Version 2.0)

Overall Survival

Overall Study

Floxuridine

Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)

Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)

Mitomycin, doxifluridine and cisplatin

Mitomycin and doxifluridine

This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.

Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized trials investigating the role of adjuvant chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still controversial and varied between Western and Asian trials. Meta-analysis of Western trials didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected gastric cancer compared to no treatment.

This study is designed to evaluate the efficacy of mitomycin, cisplatin and prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.

A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma

Relapse-free survival at 3 years was defined as the proportion of patients who did not show an evidence of disease recurrence after 3 years of surgery.

Relapse was defined as any new tumor lesion.

Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery.

Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years

Mitomycin Plus Short-term Fluoropyrimidine

Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati

Mitomycin and Doxifluridine

Experimental armMitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients	NCT01401075	Gastric Cancer	mistletoe extra... doxifluridine	19 Years - 70 Years	Abnoba Gmbh
Trial of Adjuvant Chemotherapy for Gastric Cancer	NCT00296322	Stomach Cancer	cisplatin, mito...	18 Years - 69 Years	Asan Medical Center
Trial of Adjuvant Chemotherapy for Gastric Cancer	NCT00296322	Stomach Cancer	cisplatin, mito...	18 Years - 69 Years	Asan Medical Center
RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients	NCT01401075	Gastric Cancer	mistletoe extra... doxifluridine	19 Years - 70 Years	Abnoba Gmbh
Trial of Adjuvant Chemotherapy for Gastric Cancer	NCT00296322	Stomach Cancer	cisplatin, mito...	18 Years - 69 Years	Asan Medical Center
Trial of Adjuvant Chemotherapy for Gastric Cancer	NCT00296335	Stomach Cancer	Mitomycin, doxi... Mitomycin and d...	18 Years - 69 Years	Asan Medical Center

Spots Global Cancer Trial Database for doxifluridine