Oesophageal CancerPhase 3PREHABNCT02780921
Effect of Prehabilitation in Gastroesophageal Adenocarcinoma: Study Protocol of a Multicentric, Randomised Control Trial
A Phase 3 study testing prehabilitation and nutritional support in people with Oesophageal Cancer and Gastric Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Perioperative chemotherapy is the gold standard treatment in the resectable and advanced gastroesophageal adenocarcinoma. The efficacy of this strategy has been demonstrated in two randomized studies (1,2). It reduces tumour size before surgery, treats micrometastases and evaluates chemosensitivity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Cancer, Gastric Cancer
- What is being tested?
- prehabilitation and nutritional support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Mar 2018
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old.
- Patient who agreed to participate in the study
- Patient requiring surgical management for the cancer of the esophagus or stomach.
- Patient who have a standard perioperative chemotherapy:
- For esophageal cancer: chemotherapy with 5-FU (or LV5-FU2) -platinum salts or Taxane-salt platinum salts, 2 to 4 cycles pre- and postoperatively.
- For stomach cancer: Perioperative chemotherapy with Epirubicin and cisplatin-5-FU (ECF), Epirubicin-oxaliplatin-5FU (EOX) or 5-FU (or LV5FU) - platinum salts, 2 to 4 cycles.
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- subscribe to the French national health insurance system and give their written consent.
- Patient speak and understand French.
- effective contraception for patients of childbearing age
Who cannot join
- Patient who for psychiatric social, family or geographical reasons, will not be able to be monitored and/or compliant with the requirements of the study.
- Patient requiring preoperative radio-chemotherapy. with any unbalanced progressive disease (hepatic failure, renal failure (creatinine clearance <30mL / min), respiratory failure, congestive heart failure, myocardial infarction in the last 6 months)
- Patient treated for another cancer within 5 years, except basal cell skin carcinoma or carcinoma in situ of the cervix.
- patient in legal incapacity (person deprived of liberty or under guardianship).
- cognitive disorders or major disability making it impossible to understand the study and sign the informed consent
- breastfeeding or pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Bertrand LE ROY
About this study
Perioperative chemotherapy is the gold standard treatment in the resectable and advanced gastroesophageal adenocarcinoma. The efficacy of this strategy has been demonstrated in two randomized studies (1,2). It reduces tumour size before surgery, treats micrometastases and evaluates chemosensitivity. Disease free and overall survival rates were significantly improved with perioperative chemotherapy compared to surgery alone. However, the limitation of these studies is that among all patients requiring chemotherapy, almost 70% of patients will not have the complete sequence. This sequence is defined by the administration of 2 to 4 cycles before and 2 to 4 cycles after the surgery, according to the protocol. The major cause of absence or impossibility of realization of postoperative chemotherapy was the presence of postoperative complication, postoperative serious asthenia and impaired nutritional and physical status (1,2). Poor physical condition assessed by cardiopulmonary exercise testing, reflecting a reduced physiological reserve, is predictive of postoperative complications (3,4). A physical training, even during a short period and on a various population, is beneficial in improving physical condition, cardiopulmonary function and muscular mass of the patient (5-8). A prehabilitation over a 6 week period between surgical consultation and surgery decreases postoperative morbidity and the hospital stay in cardiovascular surgery but no study has ever been performed in the gastric or oesophageal cancer (7,9).
Prehabilitation revolves around three axes: 1) a physical training based on initial cardiopulmonary exercise testing (VO2peak, anaerobic threshold (AT) and 6-min walk test (6MWT)), 3 times by week, supervised by a physical therapist 2) a nutritional care to ensure the compliance of the nutrition program and adapt the nutritional management based on protein and energy needs and on the level of spontaneous oral intake and 2) a psychological treatment by a psychologist to reduce preoperative anxiety. To our knowledge, no study ever focused on the gastroesophageal cancer. The benefit of prehabilitation in this cancer may be particularly important because 1) this surgery is associated with a high postoperative morbidity (40%, especially respiratory) and mortality (5%) 2) the physical and nutritional status of these patients is often precarious (cancer cachexia, gastroesophageal obstruction), and 3) the need to preoperative chemotherapy declines physical reserves and is associated with a lengthening of the time between consultation and surgery of more than 3 months (10). Also, the investigators hypothesize that with a physical training, a personalized nutritional support and a psychologist management may decrease postoperative complications, increase postoperative nutritional status and so, would allow for more patients to receive their full cancer treatment. The aim of this study was to evaluate, in gastroesophageal adenocarcinoma, the effect of prehabilitation compared to conventional care, the percentage of patients reaching the complete oncological treatment decided in a multidisciplinary tumour board.
Read the detailed description
Interventions After the first visit with his surgeon, the patient will be presented at the multidisciplinary tumour board to validate the inclusion criteria and to schedule the number of cycles of pre- and postoperative chemotherapy. After this step, a second consultation with the surgeon will allow to verify all inclusion and exclusion criteria and perform the randomization. For the two groups, an initial (before chemotherapy) and final (one week before the surgery) evaluation will be performed. The evaluation includes cardiopulmonary exercise testing (VO2peak, AT and 6MWT), nutritional evaluation (albumin), bioelectric impedance analysis, evaluation of physical activity and ingesta, evaluation of the level of depressive symptoms and anxiety with the HADS questionnaire and the quality of life (5Q-FD questionnaire).
Prehab group Exercise intervention: The total-body exercise will consist of up to 1 hour of supervised exercise for at least 3 days per week, for a total of 18 cycles, alternating between aerobic and resistance training. Exercise intensity will be prescribed based on the rate of the 6MWT, AT and VO2peak. The participant will exercise in the presence of the kinesiologist who will provide corrective feedback if necessary.
Nutrition intervention: Initially, a nutritionist will perform a medical and biological examination of the nutritional status to provide individualized care to each patient. Individual protein requirements will be calculated as 1.2 g of protein per kilogram of body weight (adjusted body weight was used for obese patients), as per European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines, regarding surgical patients (12). Patients will be asked to consume the protein supplement within one hour of their exercise regimen to capitalize on postexercise muscle protein synthesis (13). Then, a dietician will assess the compliance of the nutritional support at each cycle of chemotherapy and will adjust it if necessary. After the preoperative chemotherapy, a second evaluation by a nutritionist will be performed.
Psychologist intervention: Patients will receive up to a one hour visit with a trained psychologist who will provide techniques aiming to reducing anxiety, such as relaxation exercises based on imagery and visualization, together with breathing exercises. Each patient will practice these exercises with the psychologist initially and at each cycle of chemotherapy and at home two to three times per week. The psychologist also provides suggestions on how to enhance and reinforce patients' motivation to comply with the exercise and nutritional aspects of the intervention.
Control group:
The control group will be treated according to conventional care; will not receive any specific intervention before surgery except nutritional support and physiotherapy at the surgeon's discretion.
- Conditions
- Oesophageal Cancer, Gastric Cancer
- Being tested
- prehabilitation, nutritional support
- Keywords
- Prehabilitation, Oesophageal cancer, Gastric cancer, Fitness, Preconditionning, two parallel arms
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prehabilitationProcedure or surgery
nutritional supportOther
| Study group | Role | What they receive |
|---|---|---|
| Prehab Group | Experimental | In the experimental group (Prehab group) compared to the control group, the main objective will be to demonstrate an improvement of the percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board Receives: Procedure: prehabilitation |
| control group | Other | The control group will be treated according to conventional care; will not receive any specific intervention before surgery except nutritional support and physiotherapy at the surgeon's discretion Receives: Other: nutritional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board
In the experimental group (Prehab group) compared to the control group, the main objective will be the percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board.
Measured: at inclusion
Secondary outcomes (13)
effect of the prehabilitation on the postoperative morbidity on the postoperative morbidity according Dindo-Clavien classification
according Dindo-Clavien classification, a scale from 0 (no postoperative morbidity) to 5 (postoperative death)
Measured: at 3 months
evaluation of the effect of the prehabilitation on severe morbidity (Clavien >2)
severe morbidity at 3 months (Clavien >2), defined by an interventional or surgical treatment
Measured: at 3 months
disease free survival (DFS)
disease free survival (DFS), survival defined by the time in months before recurrence at 3- and 5-years after the end of the postoperative chemotherapy
Measured: at 3 and 5 years
overall survival (OS)
overall survival (OS), defined by the time in months of the overall survival at 3- and 5 years after the end of the postoperative chemotherapy.
Measured: at 3 and 5 years
feasibility of the protocol
feasibility of the protocol defined by the percentage of physical sessions realized on the eighteen proposed in the preoperative period
Measured: at inclusion
length (in days) of postoperative stay
Measured: at 3 months
difference between the initial (before preoperative chemotherapy) and final (after preoperative chemotherapy) VO2 at the ventilatory threshold (ml.min-1.kg-1).
Measured: at 3 months
difference between the initial (before preoperative chemotherapy) and final (after preoperative chemotherapy) value of VO2peak (ml.min-1.kg-1.).
Measured: at 3 months
difference between the initial (before preoperative chemotherapy) and final (after preoperative chemotherapy) walking distance in 6 min (meters).
Measured: at 3 months
difference between the initial (before preoperative chemotherapy) and final (after preoperative chemotherapy) weight (Kg)
Measured: at 3 months
difference between the initial (before preoperative chemotherapy) and final (after preoperative chemotherapy) albuminemia (g/l)
Measured: at 3 months
evaluation on the score of HADS survey (Hospital anxiety and depression scale)
difference between the initial (before preoperative chemotherapy) and final (after preoperative chemotherapy) evaluation on the score of HADS survey (Hospital anxiety and depression scale) to assess the anxiety and depression from a survey with 14 questions.
Measured: at 3 months
quality of life
difference of the score between the initial evaluation (before preoperative chemotherapy) and at 3-months after the surgery of the quality of life defined by the EQ-5D survey.
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
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 Oesophageal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780921
- Sponsor's protocol ID
- CHU-0263
- Other IDs
- 2015-A01733-46
- Acronym
- PREHAB
- Status last verified
- Jan 2017
- First submitted
- 28 Apr 2016
- Last updated
- 25 Jan 2017
- Results posted
- No
Publications
Le Roy B, Pereira B, Bouteloup C, Costes F, Richard R, Selvy M, Petorin C, Gagniere J, Futier E, Slim K, Meunier B, Mabrut JY, Mariette C, Pezet D. Effect of prehabilitation in gastro-oesophageal adenocarcinoma: study protocol of a multicentric, randomised, control trial-the PREHAB study. BMJ Open. 2016 Dec 7;6(12):e012876. doi: 10.1136/bmjopen-2016-012876.
PubMed 27927660
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prehabilitation in Gastroesophageal Adenocarcinoma: Study Protocol of a Multicentric, Randomised Control Trial
- ClinicalTrials.gov ID
- NCT02780921
- Acronym / sponsor ID
- PREHAB / CHU-0263
- Conditions
- Oesophageal Cancer, Gastric Cancer
- Keywords
- Prehabilitation, Oesophageal cancer, Gastric cancer, Fitness, Preconditionning, two parallel arms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 24 May 2016 (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.
Perioperative chemotherapy is the gold standard treatment in the resectable and advanced gastroesophageal adenocarcinoma. The efficacy of this strategy has been demonstrated in two randomized studies (1,2). It reduces tumour size before surgery, treats micrometastases and evaluates chemosensitivity. Disease free and overall survival rates were significantly improved with perioperative chemotherapy compared to surgery alone. However, the limitation of these studies is that among all patients requiring chemotherapy, almost 70% of patients will not have the complete sequence. This sequence is defined by the administration of 2 to 4 cycles before and 2 to 4 cycles after the surgery, according to the protocol. The major cause of absence or impossibility of realization of postoperative chemotherapy was the presence of postoperative complication, postoperative serious asthenia and impaired nutritional and physical status (1,2). Poor physical condition assessed by cardiopulmonary exercise testing, reflecting a reduced physiological reserve, is predictive of postoperative complications (3,4). A physical training, even during a short period and on a various population, is beneficial in improving physical condition, cardiopulmonary function and muscular mass of the patient (5-8). A prehabilitation over a 6 week period between surgical consultation and surgery decreases postoperative morbidity and the hospital stay in cardiovascular surgery but no study has ever been performed in the gastric or oesophageal cancer (7,9).
Prehabilitation revolves around three axes: 1) a physical training based on initial cardiopulmonary exercise testing (VO2peak, anaerobic threshold (AT) and 6-min walk test (6MWT)), 3 times by week, supervised by a physical therapist 2) a nutritional care to ensure the compliance of the nutrition program and adapt the nutritional management based on protein and energy needs and on the level of spontaneous oral intake and 2) a psychological treatment by a psychologist to reduce preoperative anxiety. To our knowledge, no study ever focused on the gastroesophageal cancer. The benefit of prehabilitation in this cancer may be particularly important because 1) this surgery is associated with a high postoperative morbidity (40%, especially respiratory) and mortality (5%) 2) the physical and nutritional status of these patients is often precarious (cancer cachexia, gastroesophageal obstruction), and 3) the need to preoperative chemotherapy declines physical reserves and is associated with a lengthening of the time between consultation and surgery of more than 3 months (10). Also, the investigators hypothesize that with a physical training, a personalized nutritional support and a psychologist management may decrease postoperative complications, increase postoperative nutritional status and so, would allow for more patients to receive their full cancer treatment. The aim of this study was to evaluate, in gastroesophageal adenocarcinoma, the effect of prehabilitation compared to conventional care, the percentage of patients reaching the complete oncological treatment decided in a multidisciplinary tumour board.
Detailed description
Interventions After the first visit with his surgeon, the patient will be presented at the multidisciplinary tumour board to validate the inclusion criteria and to schedule the number of cycles of pre- and postoperative chemotherapy. After this step, a second consultation with the surgeon will allow to verify all inclusion and exclusion criteria and perform the randomization. For the two groups, an initial (before chemotherapy) and final (one week before the surgery) evaluation will be performed. The evaluation includes cardiopulmonary exercise testing (VO2peak, AT and 6MWT), nutritional evaluation (albumin), bioelectric impedance analysis, evaluation of physical activity and ingesta, evaluation of the level of depressive symptoms and anxiety with the HADS questionnaire and the quality of life (5Q-FD questionnaire).
Prehab group Exercise intervention: The total-body exercise will consist of up to 1 hour of supervised exercise for at least 3 days per week, for a total of 18 cycles, alternating between aerobic and resistance training. Exercise intensity will be prescribed based on the rate of the 6MWT, AT and VO2peak. The participant will exercise in the presence of the kinesiologist who will provide corrective feedback if necessary.
Nutrition intervention: Initially, a nutritionist will perform a medical and biological examination of the nutritional status to provide individualized care to each patient. Individual protein requirements will be calculated as 1.2 g of protein per kilogram of body weight (adjusted body weight was used for obese patients), as per European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines, regarding surgical patients (12). Patients will be asked to consume the protein supplement within one hour of their exercise regimen to capitalize on postexercise muscle protein synthesis (13). Then, a dietician will assess the compliance of the nutritional support at each cycle of chemotherapy and will adjust it if necessary. After the preoperative chemotherapy, a second evaluation by a nutritionist will be performed.
Psychologist intervention: Patients will receive up to a one hour visit with a trained psychologist who will provide techniques aiming to reducing anxiety, such as relaxation exercises based on imagery and visualization, together with breathing exercises. Each patient will practice these exercises with the psychologist initially and at each cycle of chemotherapy and at home two to three times per week. The psychologist also provides suggestions on how to enhance and reinforce patients' motivation to comply with the exercise and nutritional aspects of the intervention.
Control group:
The control group will be treated according to conventional care; will not receive any specific intervention before surgery except nutritional support and physiotherapy at the surgeon's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehab Group | Experimental | Procedure: prehabilitationIn the experimental group (Prehab group) compared to the control group, the main objective will be to demonstrate an improvement of the percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board |
| control group | Other | Other: nutritional supportThe control group will be treated according to conventional care; will not receive any specific intervention before surgery except nutritional support and physiotherapy at the surgeon's discretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- > 18 years old.
- Patient who agreed to participate in the study
- Patient requiring surgical management for the cancer of the esophagus or stomach.
- Patient who have a standard perioperative chemotherapy:
- For esophageal cancer: chemotherapy with 5-FU (or LV5-FU2) -platinum salts or Taxane-salt platinum salts, 2 to 4 cycles pre- and postoperatively.
Key exclusion criteria (6 listed)
- Patient who for psychiatric social, family or geographical reasons, will not be able to be monitored and/or compliant with the requirements of the study.
- Patient requiring preoperative radio-chemotherapy. with any unbalanced progressive disease (hepatic failure, renal failure (creatinine clearance <30mL / min), respiratory failure, congestive heart failure, myocardial infarction in the last 6 months)
- Patient treated for another cancer within 5 years, except basal cell skin carcinoma or carcinoma in situ of the cervix.
- patient in legal incapacity (person deprived of liberty or under guardianship).
- cognitive disorders or major disability making it impossible to understand the study and sign the informed consent
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 |
|---|---|---|
| prehabilitation | Procedure or surgery | Prehab Group |
| nutritional support | Other | control group |
Primary outcome
percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board
Time frame: at inclusion
In the experimental group (Prehab group) compared to the control group, the main objective will be the percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board.
13 secondary outcomes
effect of the prehabilitation on the postoperative morbidity on the postoperative morbidity according Dindo-Clavien classification
Time frame: at 3 months
evaluation of the effect of the prehabilitation on severe morbidity (Clavien >2)
Time frame: at 3 months
disease free survival (DFS)
Time frame: at 3 and 5 years
overall survival (OS)
Time frame: at 3 and 5 years
feasibility of the protocol
Time frame: at inclusion
length (in days) of postoperative stay
Time frame: at 3 months
difference between the initial (before preoperative chemotherapy) and final (after preoperative chemotherapy) VO2 at the ventilatory threshold (ml.min-1.kg-1).
Time frame: at 3 months
difference between the initial (before preoperative chemotherapy) and final (after preoperative chemotherapy) value of VO2peak (ml.min-1.kg-1.).
Time frame: at 3 months
difference between the initial (before preoperative chemotherapy) and final (after preoperative chemotherapy) walking distance in 6 min (meters).
Time frame: at 3 months
difference between the initial (before preoperative chemotherapy) and final (after preoperative chemotherapy) weight (Kg)
Time frame: at 3 months
difference between the initial (before preoperative chemotherapy) and final (after preoperative chemotherapy) albuminemia (g/l)
Time frame: at 3 months
evaluation on the score of HADS survey (Hospital anxiety and depression scale)
Time frame: at 3 months
quality of life
Time frame: at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Derived from this study: PubMed 27927660Le Roy B, Pereira B, Bouteloup C, Costes F, Richard R, Selvy M, Petorin C, Gagniere J, Futier E, Slim K, Meunier B, Mabrut JY, Mariette C, Pezet D. Effect of prehabilitation in gastro-oesophageal adenocarcinoma: study protocol of a multicentric, randomised, control trial-the PREHAB study. BMJ Open. 2016 Dec 7;6(12):e012876. doi: 10.1136/bmjopen-2016-012876.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing prehabilitation and nutritional support in people with Oesophageal Cancer and Gastric Cancer, run by University Hospital, Clermont-Ferrand 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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Jan 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 51 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board (time frame: at inclusion). 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 NCT02780921, 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 25 Jan 2017.