Gastric AdenocarcinomaPhase 2NCT01565109
NESC: Neoadjuvant Treatment of Gastric Adenocarcinoma
A Phase 2 study testing Docetaxel - Cisplatine - 5FU and Radiation of 45 Grays on 5 weeks in people with Gastric Adenocarcinoma, run by Recherche clinique at 1 site in France.
Trial summary
It is estimated to 7300 the number of new cases of gastric cancer each year in France. According to a randomized trial comparing 3 cycles of ECF (epirubicin, cisplatin, 5FU) administered before surgery and 3 cycles after surgery with surgery alone in adenocarcinoma of the stomach and lower esophagus, clinical and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Docetaxel - Cisplatine - 5FU and Radiation of 45 Grays on 5 weeks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Mar 2018
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, Age: 18 to 65
- ECOG performance status of ≤ 1
- Histological documentation of the gastric adenocarcinoma. An extension will be admitted to the omentum
- Adenocarcinoma of the stomach according to staging classification TNM Scannographic: T2bN0, T2bN1, T3NO T3N +, T4N0, and T4N + M0 (cardia, Siewert II, III, fundus, body, antrum) performed by ultrasonography and CT Scan. Optional : laparoscopy
- A positive peritoneal cytology is not a disqualifying factor if there is no macroscopic carcinomatosis
- Absence of previous abdominal irradiation above the 5th sacral vertebra (in the liver, pancreas, spleen, or mediastinal lodge)
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- Loss of weight less than 15% over the base weight before diagnosis
- No psychological, familial, sociological or geographical condition that may affect compliance and adherence to treatment, patient monitoring or understanding of the study.
- Signed informed consent obtained before any study specific procedures.
- Food Consumption> 1000 calories / day whatever the mode of administration (enteral or parenteral)
- Laboratory test conducted within one week of starting to study treatment:
- Absolute neutrophil count > 1500/mm3
- Platelet count > 100 000/mm3
- Total bilirubin <2 mg/dL
- Serum creatinine <13 mg/dL or creatinine clearance > 40 ml/min
- Hemoglobin (Hgb) ≥ 10 g/dL (Hemoglobin transfusion if necessary)
- ALT / AST <1.5 x ULN
- PTT ≥ 60 %
- Life expectancy of at least 3 months
Who cannot join
- Peripheral sensory neuropathy ≥ grade 1 (according to CTCAE version 3.0).
- Myocardial infarction, stroke or pulmonary embolism, unstable angina less than 6 months before start of study drug.
- Uncontrolled infection
- Pregnant or breast-feeding patients. Women of childbearing potential must have a pregnancy test performed.
- Prior treatment for gastric adenocarcinoma
- Lower limbs arteritis (≥ stage II according the Leriche and Fontain classification)
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- Patient participating in another clinical trial or already receiving other anti-cancer treatment
- Concomitant treatment with a phenytoin
- Known previous / current malignancy within the last 5 years except for non-melanoma skin, non-metastatic prostate carcinoma and cervival carcinoma in situ or superficial bladder carcinoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Multicenter Study in the Preoperative Treatment of Gastric Adenocarcinoma Consisting of Chemotherapy Using Docetaxel-cisplatin-5FU + Lenograstim Followed by Chemoradiation Based 5FU and Oxaliplatin
It is estimated to 7300 the number of new cases of gastric cancer each year in France.
According to a randomized trial comparing 3 cycles of ECF (epirubicin, cisplatin, 5FU) administered before surgery and 3 cycles after surgery with surgery alone in adenocarcinoma of the stomach and lower esophagus, clinical and experimental data are the neoadjuvant chemotherapy is a new standard treatment for operable gastric cancer. This treatment with a median survival of more than 3 years to obtain a hazard ratio of 0.75 in favor of chemotherapy arm (p = 0.009). The 5-year survival being 36% for patients treated with chemotherapy versus 23% for surgery alone. Progression-free survival was also significantly prolonged with a hazard ratio of 0.66.
Read more
The proposed clinical study by Ajani et al shows that the combination of Docetaxel with the schema Cisplatin - 5FU provides greater clinical benefit and induces to consider the triple combination as a reference treatment in metastatic gastric cancer in patients under 65 years.
Preoperative radiochemotherapy is expected to increase the rate of curative resections, reduce gastrointestinal and hematologic toxicity.
Two studies evaluating the feasibility of preoperative RTCT in operable gastric adenocarcinoma with continuous 5GU (+ or - paclitaxel) and 45 Gy are available and the combination 5FU oxaliplatin has been assessed in the esophagus and rectum tumors.
The NESC study, Phase II, proposes the following schema: 2 cycles of chemotherapy with Docetaxel - Cisplatin - 5FU then preoperative chemoradiation with oxaliplatin - continuous 5FU and radiotherapy in locally advanced gastric adenocarcinoma stage III and IV non-metastatic administered before surgery.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Docetaxel - Cisplatine - 5FU, Radiation of 45 Grays on 5 weeks
- Keywords
- NESC, NEOADJUVANT, GASTRIC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel - Cisplatine - 5FUDrug
2 cycles of Docetaxel - Cisplatine - 5 FU
Radiation of 45 Grays on 5 weeksRadiation
Radiochemotherapy with Oxaliplatine (J1, J15 et J29) - 5FU on 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Experimental | Docetaxel - Cisplatine - 5FU 2 cycles of Docetaxel - Cisplatine - 5 FU
Radiation: Radiation of 45 Grays on 5 weeks Radiochemotherapy with Oxaliplatine (J1, J15 et J29) - 5FU on 5 weeks Receives: Drug: Docetaxel - Cisplatine - 5FU; Radiation: Radiation of 45 Grays on 5 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological response rate on surgical specimen after chemotherapy and chemoradiotherapy preoperative
Histological response rate
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startMar 2009
- Primary completionMar 2016
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric AdenocarcinomaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recherche clinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Recherche clinique, Institut Sainte Catherine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565109
- Sponsor's protocol ID
- NESC
- Status last verified
- Jun 2023
- First submitted
- 13 Oct 2010
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mineur L, Plat F, Desseigne F, Deplanque G, Belkacemi M, Moureau-Zabotto L, Beyrne CD, Jalali K, Obled S, Smith D, Vazquez L, Boustany R. NESC Multicenter Phase II Trial in the Preoperative Treatment of Gastric Adenocarcinoma with Chemotherapy (Docetaxel-Cisplatin-5FU+Lenograstim) Followed by Chemoradiation Based 5FU and Oxaliplatin and Surgery. Cancer Res Treat. 2024 Apr;56(2):580-589. doi: 10.4143/crt.2023.812. Epub 2023 Oct 5.
PubMed 37817565
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Study in the Preoperative Treatment of Gastric Adenocarcinoma Consisting of Chemotherapy Using Docetaxel-cisplatin-5FU + Lenograstim Followed by Chemoradiation Based 5FU and Oxaliplatin
- ClinicalTrials.gov ID
- NCT01565109
- Acronym / sponsor ID
- NESC
- Conditions
- Gastric Adenocarcinoma
- Keywords
- NESC, NEOADJUVANT, GASTRIC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Recherche cliniqueUniversity, hospital or other
- Study start
- Mar 2009 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 28 Mar 2012 (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.
It is estimated to 7300 the number of new cases of gastric cancer each year in France.
According to a randomized trial comparing 3 cycles of ECF (epirubicin, cisplatin, 5FU) administered before surgery and 3 cycles after surgery with surgery alone in adenocarcinoma of the stomach and lower esophagus, clinical and experimental data are the neoadjuvant chemotherapy is a new standard treatment for operable gastric cancer. This treatment with a median survival of more than 3 years to obtain a hazard ratio of 0.75 in favor of chemotherapy arm (p = 0.009). The 5-year survival being 36% for patients treated with chemotherapy versus 23% for surgery alone. Progression-free survival was also significantly prolonged with a hazard ratio of 0.66.
The proposed clinical study by Ajani et al shows that the combination of Docetaxel with the schema Cisplatin - 5FU provides greater clinical benefit and induces to consider the triple combination as a reference treatment in metastatic gastric cancer in patients under 65 years.
Preoperative radiochemotherapy is expected to increase the rate of curative resections, reduce gastrointestinal and hematologic toxicity.
Two studies evaluating the feasibility of preoperative RTCT in operable gastric adenocarcinoma with continuous 5GU (+ or - paclitaxel) and 45 Gy are available and the combination 5FU oxaliplatin has been assessed in the esophagus and rectum tumors.
The NESC study, Phase II, proposes the following schema: 2 cycles of chemotherapy with Docetaxel - Cisplatin - 5FU then preoperative chemoradiation with oxaliplatin - continuous 5FU and radiotherapy in locally advanced gastric adenocarcinoma stage III and IV non-metastatic administered before surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Experimental | Drug: Docetaxel - Cisplatine - 5FU, Radiation: Radiation of 45 Grays on 5 weeksDocetaxel - Cisplatine - 5FU 2 cycles of Docetaxel - Cisplatine - 5 FU Radiation: Radiation of 45 Grays on 5 weeks Radiochemotherapy with Oxaliplatine (J1, J15 et J29) - 5FU on 5 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female patients, Age: 18 to 65
- ECOG performance status of ≤ 1
- Histological documentation of the gastric adenocarcinoma. An extension will be admitted to the omentum
- Adenocarcinoma of the stomach according to staging classification TNM Scannographic: T2bN0, T2bN1, T3NO T3N +, T4N0, and T4N + M0 (cardia, Siewert II, III, fundus, body, antrum) performed by ultrasonography and CT Scan. Optional : laparoscopy
- A positive peritoneal cytology is not a disqualifying factor if there is no macroscopic carcinomatosis
Key exclusion criteria (9 listed)
- Peripheral sensory neuropathy ≥ grade 1 (according to CTCAE version 3.0).
- Myocardial infarction, stroke or pulmonary embolism, unstable angina less than 6 months before start of study drug.
- Uncontrolled infection
- Pregnant or breast-feeding patients. Women of childbearing potential must have a pregnancy test performed.
- Prior treatment for gastric adenocarcinoma
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 |
|---|---|---|
| Docetaxel - Cisplatine - 5FU2 cycles of Docetaxel - Cisplatine - 5 FU | Drug | Single arm study |
| Radiation of 45 Grays on 5 weeksRadiochemotherapy with Oxaliplatine (J1, J15 et J29) - 5FU on 5 weeks | Radiation | Single arm study |
Primary outcome
Histological response rate on surgical specimen after chemotherapy and chemoradiotherapy preoperative
Time frame: 1year
Histological response rate
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 22 Jan 2025.
- Derived from this study: PubMed 37817565Mineur L, Plat F, Desseigne F, Deplanque G, Belkacemi M, Moureau-Zabotto L, Beyrne CD, Jalali K, Obled S, Smith D, Vazquez L, Boustany R. NESC Multicenter Phase II Trial in the Preoperative Treatment of Gastric Adenocarcinoma with Chemotherapy (Docetaxel-Cisplatin-5FU+Lenograstim) Followed by Chemoradiation Based 5FU and Oxaliplatin and Surgery. Cancer Res Treat. 2024 Apr;56(2):580-589. doi: 10.4143/crt.2023.812. Epub 2023 Oct 5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel - Cisplatine - 5FU and Radiation of 45 Grays on 5 weeks in people with Gastric Adenocarcinoma, run by Recherche clinique at 1 site in France.
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 19 inclusion and 9 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 22 Jan 2025. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Histological response rate on surgical specimen after chemotherapy and chemoradiotherapy preoperative (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01565109, which also lists 1 linked publication.
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 22 Jan 2025.