Pre-Operative Or Peri-Operative Dox Regimen In Patients With Locally Advanced Resectable Gastric Cancer

NCT01876927 | Completed Phase 2

• 2 other identifiers: IRST151.012010-020189-37
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 20

Brief Summary

Study design: Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up Population: Male or female, 18-75 years of age, with a diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach. Sample Size: Planned sample size is 90 patients, 45 patients for each arm (p0=50%, p1=80%, alpha=0.05 (two sides), beta=0.2) Treatment Plan: Treatment will be administered for 4 and 2 cycles before surgery in arm A and B, respectively, and in arm B for a further 2 cycles after surgery unless progression or unacceptable toxicity occurs, or a patient refuses treatment. In such cases patients will go off treatment. 3-6 weeks after the end of the fourth (arm A) or second (arm B) preoperative cycle, patients will undergo surgery. After surgery 3-6 weeks from surgery patients in arm B will receive 2 more cycles. DOX: Docetaxel 35 mg/m2 day 1 and 8 Oxaliplatin 80 mg/m2 day 1 Capecitabine 750 mg/m2 x 2 daily for 2 weeks Cycles repeated every 3 weeks Evaluation criteria: Tumor assessment will be performed according to the RECIST criteria (version 1.1). Duration of Study: Overall study duration: 07/2010- 03/2017 Planned study duration per patient: 5 years

Conditions

Gastric Cancer; Locally Advanced Malignant Neoplasm

Keywords

Locally; Advanced; Resectable; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• the difference in percentage of patients receiving all the planned chemotherapeutic cycles between the two arms.

  7 years

Secondary Outcomes (11)

• The percentage of tumors downstaged at the diagnosis

  7 years

• Treatment tolerability and safety and tumor response in patients with pathological stage pT1-3 vs pT0

  7 years

• Number of patients with adverse events of grade 3-4 as a measure of safety and tolerability

  7 years

• Diagnostic capability of PET

  7 years

• Efficacy comparation between curative vs palliative surgery

  7 years

Study Arms (2)

Arm A

EXPERIMENTAL

DOX 4 cycles - Surgery - Follow-up DOX: Docetaxel 35 mg/m2 day 1 and 8 by one hour infusion; Oxaliplatin 80 mg/m2 day 1 by two hours infusion; Capecitabine 750 mg/m2 x 2 daily for 2 weeks, per OS. Treatment should be administered for 4 cycles before surgery. Each cycle will be repeated every 3 weeks.

Other: DOX 4 cycles - Surgery

Arm B

EXPERIMENTAL

DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up DOX: Docetaxel 35 mg/m2 day 1 and 8 by one hour infusion; Oxaliplatin 80 mg/m2 day 1 by two hours infusion; Capecitabine 750 mg/m2 x 2 daily for 2 weeks, per OS. Treatment should be administered for 2 cycles before surgery and for further 2 cycles after surgery, unless progression of disease or unacceptable toxicity occurs, or patient refusal. In these cases patients will go off treatment. Each cycle will be repeated every 3 weeks.

Other: DOX 2 cycles - Surgery - DOX 2 cycles

Interventions

DOX 4 cycles - Surgery OTHER

DOX 4 cycles - Surgery

Arm A

DOX 2 cycles - Surgery - DOX 2 cycles OTHER

DOX 2 cycles - Surgery - DOX 2 cycles

Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consents
• Male or female 18-75 years of age
• Diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach
• cT3 subserosal - cT4a - cT4b (7th edition UICC TNM) or bulky lymph node metastases independently of T
• ECOG performance status of 0-1 at study entry
• Laboratory requirements (≤ 7 days prior chemotherapy start):
• Hematology:
• I) Neutrophils \> 1.5 x 109 /L II) Platelets \> 100 x 109 /L III) Hemoglobin \> 10g/dL
• Hepatic function I) Total bilirubin \< 1.25 UNL II) AST (SGOT) and ALT (SGPT) \< 2.5xUNL III) Alkaline phosphatase \< 2.5xUNL
• Renal function I) Creatinine \<1.5 UNL In the event of border-line values, the calculated creatinine clearance should be \> 60 mL/min;
• Written informed consent signed and dated before randomization procedures, including expected cooperation of patients for treatment and follow-up, must be obtained and documented according to local regulatory requirements.
• Effective contraception for both male and female patients if the risk of conception exists

You may not qualify if:

• Early gastric cancer (if N0)
• T2 (according to 7th edition of UICC TNM) if N0
• Linitis plastica
• Positive peritoneal cytology
• Distant metastases
• Neoplasm involving the gastro-esophageal junction
• Pertoneal involvement
• Concurrent chronic systemic immune therapy
• Any investigational agent(s) administered 4 weeks prior to entry
• Clinically relevant coronary artery disease, a history of myocardial infarction or of hypertension not controlled by therapy within the last 12 months
• Known grade 3 or 4 allergic reaction to any of the components of the treatment
• Known drug abuse/alcohol abuse
• Legal incapacity or limited legal capacity
• Medical or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent
• Women who are pregnant or breastfeeding

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (20)

Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - GM Lancisi

Ancona, AN, Italy

Location

USL 8 Arezzo - Presidio Ospedaliero Zona Casentino - Ospedale di Bibbiena

Bibbiena, AR, Italy

Location

USL 8 Arezzo - Ospedale "Santa Maria alla Gruccia"

Montevarchi, AR, Italy

Location

UO Oncologia , Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Location

Ospedale Bufalini

Cesena, FC, Italy

Location

UO oncologia medica IRCCS IRST

Meldola (FC), FC, 47014, Italy

Location

UOC Oncologia , Azienda USL 11

Empoli, FI, 50053, Italy

Location

Ospedale Careggi

Florence, FI, Italy

Location

UO ONCOLOGIA , Istituto Europeo di Oncologia

Milan, MI, 20141, Italy

Location

Istituto Clinico Humanitas

Rozzano, MI, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, PI, Italy

Location

UO Oncologia, Fondazione Policlinico San Matteo

Pavia, PV, 27100, Italy

Location

UO Oncologia Medica, PO Rimini, AUSL della Romagna

Rimini, RI, 47923, Italy

Location

UO Oncologia , Casa di Cura Tortorella

Salerno, SA, 84122, Italy

Location

Policlinico Le Scotte

Siena, SI, Italy

Location

UO Oncologia, Azienda Ospedaliero Treviglio

Treviglio, TV, 24047, Italy

Location

UO Oncologia Medica, azienda Ospedaliera di Varese

Varese, VA, 21100, Italy

Location

Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia

Perugia, Italy

Location

Ospedale San Filippo Neri

Roma, Italy

Location

Ospedale Borgo Trento

Verona, Italy

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Manlio Monti, MD

  IRST IRCCS, Meldola

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 13, 2013
• Study Start: September 1, 2010
• Primary Completion: March 1, 2017
• Study Completion: September 15, 2022
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

IT (20)