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This study will evaluate the disease free survival rate of a combination of capecitabine [Xeloda] and oxaliplatin (XELOX) with trastuzumab [Herceptin] in patients with resectable gastric cancer. The combination of Xeloda (orally, 1000 mg/m2 on day 1-14 of every cycle) and Herceptin (intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1-14 of every cycle) will be administered for three cycles prior to surgery to resect the tumor. If complete resection, R0 or microscopic residual tumor R1 is achieved, patients will continue with three cycles of XELOX and Herceptin and then for completion of 12 months treatment with Herceptin alone. Oxaliplatin will be administered intravenously at a dose of 130 mg/m2 on day 1 in every cycle. The anticipated time on study drug will be 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine [Xeloda] | Drug | 1.000 mg/m2 orally every 12 hours from day 1 to day 14 of every cycle for 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease-free Survival (DFS) at Month 18 | DFS was the time elapsed from the time of surgery (for complete resection [R0] participants) until the date on which progression or death from any cause was documented (whichever occured first). Progression was defined as target lesions greater than (>) 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 millimeter (mm) increase over the nadir. When the sum becomes very small, increases within the measurement error (2-3 mm) can lead to a 20% increase. Participants who did not present progression and who had not died were censored on the last date on which it was known that there was no progression (last response assessment). | Month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pathological Complete Response (pCR) | pCR was defined as an absence of any invasive cancer cell of the primary tumor after the time of major neoadjuvant chemotherapy, with or without surgery. | Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elche | Alicante | 03203 | Spain | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33485079 | Derived | Rivera F, Izquierdo-Manuel M, Garcia-Alfonso P, Martinez de Castro E, Gallego J, Limon ML, Alsina M, Lopez L, Galan M, Falco E, Manzano JL, Gonzalez E, Munoz-Unceta N, Lopez C, Aranda E, Fernandez E, Jorge M, Jimenez-Fonseca P. Perioperative trastuzumab, capecitabine and oxaliplatin in patients with HER2-positive resectable gastric or gastro-oesophageal junction adenocarcinoma: NEOHX phase II trial. Eur J Cancer. 2021 Mar;145:158-167. doi: 10.1016/j.ejca.2020.12.005. Epub 2021 Jan 20. |
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Screening period comprised of 35 days. A total of 136 participants were included in the study, of which 36 participants were enrolled and 100 participants discontinued due to screening failures. Abbreviation of AE= adverse event.
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| ID | Title | Description |
|---|---|---|
| FG000 | Capecitabine+Oxaliplatin+Trastuzumab | Participants received 3 cycles of capecitabine (1,000 milligrams per meter squared [mg/m^2] tablet orally [p.o] twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute intravenous [IV] infusion, Day 1 of the cycle)/trastuzumab (8 milligrams per kilograms [mg/kg] on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Oxaliplatin | Drug | 130 mg/m2 intravenous infusion day 1 of every cycle |
|
| Trastuzumab [Herceptin] | Drug | First dose 8 mg/kg, subsequent cycles 6 mg/kg, intravenously, day of every cycle for 15 cycles |
|
| Percentage of Participants With Complete Tumor Resection (R0) | R0 resection was defined as having performed a complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation. | Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25 |
| Percentage of Participants With Objective Response | An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR was defined as the disappearance of all target lesions and persistence of greater than or equal to (≥) 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. | Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25 |
| Palma de Mallorca |
| Balearic Islands |
| 07198 |
| Spain |
| Barcelona | Barcelona | 08003 | Spain |
| Barcelona | Barcelona | 08035 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Barcelona | Barcelona | 08907 | Spain |
| Barcelona | Barcelona | 08916 | Spain |
| Burgos | Burgos | 09006 | Spain |
| Santander | Cantabria | 39008 | Spain |
| Córdoba | Cordoba | 14004 | Spain |
| Granada | Granada | 18014 | Spain |
| Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| A Coruña | La Coruña | 15006 | Spain |
| León | Leon | 24071 | Spain |
| Lleida | Lerida | 25198 | Spain |
| Lugo | Lugo | 27003 | Spain |
| Madrid | Madrid | 28007 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Ourense | Orense | 32005 | Spain |
| Vigo | Pontevedra | 36204 | Spain |
| Oviedo | Principality of Asturias | 33006 | Spain |
| Seville | Sevilla | 41013 | Spain |
| Seville | Sevilla | 41014 | Spain |
| San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Toledo | Toledo | 45004 | Spain |
| Valencia | Valencia | 46009 | Spain |
| Valencia | Valencia | 46014 | Spain |
| Barakaldo | Vizcaya | 48903 | Spain |
| Zaragoza | Zaragoza | 50009 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Capecitabine+Oxaliplatin+Trastuzumab | Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Disease-free Survival (DFS) at Month 18 | DFS was the time elapsed from the time of surgery (for complete resection [R0] participants) until the date on which progression or death from any cause was documented (whichever occured first). Progression was defined as target lesions greater than (>) 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 millimeter (mm) increase over the nadir. When the sum becomes very small, increases within the measurement error (2-3 mm) can lead to a 20% increase. Participants who did not present progression and who had not died were censored on the last date on which it was known that there was no progression (last response assessment). | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 18 |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With Pathological Complete Response (pCR) | pCR was defined as an absence of any invasive cancer cell of the primary tumor after the time of major neoadjuvant chemotherapy, with or without surgery. | ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Tumor Resection (R0) | R0 resection was defined as having performed a complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation. | ITT population. Here "number of participants analyzed" included those who underwent surgery. | Posted | Number | 95% Confidence Interval | percentage of participants | Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response | An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR was defined as the disappearance of all target lesions and persistence of greater than or equal to (≥) 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. | ITT population. | Posted | Number | percentage of participants | Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25 |
|
Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Capecitabine+Oxaliplatin+Trastuzumab | Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death. | 22 | 36 | 35 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiogenic shock | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Localised intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Schizoaffective disorder | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
|
|
| Units | Counts |
|---|---|
| Participants |
|
|