Gastric CancerNCT02454647
Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients
An observational study of Gastric Cancer and Adenocarcinoma, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
The aim of this study is to evaluate the efficacy of a neoadjuvant approach in patients with locally advanced gastric cancer and the identification of prognostic factors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Adenocarcinoma, Effects of Chemotherapy
- What is being tested?
- Induction chemotherapy, Radiotherapy with concurrent chemotherapy and Salvage surgery
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced adenocarcinoma of the stomach treated with a neoadjuvant protocol consisting of induction chemotherapy (ICT), chemoradiotherapy (CRT)and salvage surgery. Patients must have a medically fit condition to complete the protocol. Initial staging comprises a thoracic and abdominal computerised tomography scan, endoscopic ultrasound endoscopy (EUS), biopsy and blood test including blood cell count, hepatic and renal function. Radiological and endoscopic evaluations are performed at baseline and at the completion of ICT and CRT. Blood tests are acquired at baseline, before each chemotherapy course and concurrently with evaluations. Blood tests are also obtained during follow-up and at the time progression.
Who may be able to join
- Histologically confirmed adenocarcinoma of the stomach
- Age ≥18 years old
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Body mass index ≥ 18
- No prior chemotherapy or chemoradiotherapy
- TNM stage of T3-T4 and/or positive regional lymph nodes (N+) by endoscopic ultrasound or computed tomography (CT)
- No evidence of metastasis (M0)
- Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)
Who cannot join
- Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated
- Patients with evidence of severe or uncontrolled systemic disease
- Medically unfit for chemotherapy
- Tumors involving the esophageal junction, comprising siewert I to III
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Induction Chemotherapy, Chemo-radiotherapy and Surgery in Locally Advanced Gastric Cancer Patients: Long Term Results From a Single Institution.
The aim of this study is to evaluate the efficacy of a neoadjuvant approach in patients with locally advanced gastric cancer and the identification of prognostic factors.
Read the detailed description
Patients with locally advanced gastric cancer (T3-4 and/or N+) are included. Initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound.
The neoadjuvant strategy consists of 3-4 cycles of induction chemotherapy followed by concurrent chemoradiotherapy. Chemoradiotherapy comprises weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 Gy). Surgery is scheduled 4 to 6 weeks after the end of CRT. Pathological response is graded according to the Becker criteria. Statistical analysis is performed IBM SPSS v20.
Estimate whether R0 resection rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted by dynamic prognostic factors as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR)
- Conditions
- Gastric Cancer, Adenocarcinoma, Effects of Chemotherapy, Surgery, Gastrointestinal Neoplasms
- Being tested
- Induction chemotherapy, Radiotherapy with concurrent chemotherapy, Salvage surgery
- Keywords
- Radiotherapy, Neoadjuvant therapy, Induction chemotherapy, Concurrent chemoradiotherapy, Preoperative factors, Dynamic factors, Prognostic Factor
- Medical subject headings
- Stomach Neoplasms, Adenocarcinoma, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction chemotherapyDrug
Radiotherapy with concurrent chemotherapyRadiation
Salvage surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall was defined as the period from diagnosis until death (from any cause).
Measured: From date of treatment until death, assessed up to 10 years
Identification of prognostic factors for overall survival
Overall was defined as the period from diagnosis until death (from any cause). Correlation between survival and baseline, clinical and treatment characteristics from patients
Measured: From date of treatment until death, assessed up to 10 years
Disease-free survival
Disease-free survival was defined as the time from diagnosis to the first date of local or distant cancer.
Measured: From date of diagnosis until progression or death, assessed up to 10 years
R0 resection rate
The R0 resection rate in the patients treated with the neoadjuvant protocol. R0 is defined as a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
Measured: Week 24 to 28
Secondary outcomes (3)
Pathological response
Specimen analysis according to TNM classification. Pathological complete response is defined as no invasive cancer cells in the surgical specimen.
Measured: Week 24 to 28
Patterns of treatment failure
Type of recurrence: local, regional and/or distant.
Measured: From date of diagnosis until treatment failure, assessed up to 10 years
Adverse events are assessed according to CTC criteria v 4.0
Safety and tolerability during the neoadjuvant protocol.
Measured: Week 1 to 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startSep 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- javier Rodriguez Rodriguez, MD, PhD, Principal investigator, CUN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454647
- Sponsor's protocol ID
- GC-PKPDGN
- Status last verified
- May 2015
- First submitted
- 22 May 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Chemotherapy, Chemo-radiotherapy and Surgery in Locally Advanced Gastric Cancer Patients: Long Term Results From a Single Institution.
- ClinicalTrials.gov ID
- NCT02454647
- Acronym / sponsor ID
- GC-PKPDGN
- Conditions
- Gastric Cancer, Adenocarcinoma, Effects of Chemotherapy, Surgery, Gastrointestinal Neoplasms
- Keywords
- Radiotherapy, Neoadjuvant therapy, Induction chemotherapy, Concurrent chemoradiotherapy, Preoperative factors, Dynamic factors, Prognostic Factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the efficacy of a neoadjuvant approach in patients with locally advanced gastric cancer and the identification of prognostic factors.
Detailed description
Patients with locally advanced gastric cancer (T3-4 and/or N+) are included. Initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound.
The neoadjuvant strategy consists of 3-4 cycles of induction chemotherapy followed by concurrent chemoradiotherapy. Chemoradiotherapy comprises weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 Gy). Surgery is scheduled 4 to 6 weeks after the end of CRT. Pathological response is graded according to the Becker criteria. Statistical analysis is performed IBM SPSS v20.
Estimate whether R0 resection rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted by dynamic prognostic factors as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced adenocarcinoma of the stomach treated with a neoadjuvant protocol consisting of induction chemotherapy (ICT), chemoradiotherapy (CRT)and salvage surgery. Patients must have a medically fit condition to complete the protocol. Initial staging comprises a thoracic and abdominal computerised tomography scan, endoscopic ultrasound endoscopy (EUS), biopsy and blood test including blood cell count, hepatic and renal function. Radiological and endoscopic evaluations are performed at baseline and at the completion of ICT and CRT. Blood tests are acquired at baseline, before each chemotherapy course and concurrently with evaluations. Blood tests are also obtained during follow-up and at the time progression.
Key inclusion criteria (8 listed)
- Histologically confirmed adenocarcinoma of the stomach
- Age ≥18 years old
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Body mass index ≥ 18
- No prior chemotherapy or chemoradiotherapy
Key exclusion criteria (4 listed)
- Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated
- Patients with evidence of severe or uncontrolled systemic disease
- Medically unfit for chemotherapy
- Tumors involving the esophageal junction, comprising siewert I to III
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induction chemotherapy | Drug | – |
| Radiotherapy with concurrent chemotherapy | Radiation | – |
| Salvage surgery | Procedure or surgery | – |
Primary outcome
Overall Survival
Time frame: From date of treatment until death, assessed up to 10 years
Overall was defined as the period from diagnosis until death (from any cause).
Identification of prognostic factors for overall survival
Time frame: From date of treatment until death, assessed up to 10 years
Overall was defined as the period from diagnosis until death (from any cause). Correlation between survival and baseline, clinical and treatment characteristics from patients
Disease-free survival
Time frame: From date of diagnosis until progression or death, assessed up to 10 years
Disease-free survival was defined as the time from diagnosis to the first date of local or distant cancer.
R0 resection rate
Time frame: Week 24 to 28
The R0 resection rate in the patients treated with the neoadjuvant protocol. R0 is defined as a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
3 secondary outcomes
Pathological response
Time frame: Week 24 to 28
Patterns of treatment failure
Time frame: From date of diagnosis until treatment failure, assessed up to 10 years
Adverse events are assessed according to CTC criteria v 4.0
Time frame: Week 1 to 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
javier Rodriguez Rodriguez, MD, PhD principal investigator
CUN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Adenocarcinoma, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From date of treatment until death, assessed up to 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.