Adenocarcinoma of the Gastroesophageal JunctionPhase 2/3NCT01523015
Efficacy and Safety Study of the Combined Modality Therapy in Adenocarcinoma of the Esophago-gastric Junction
A Phase 2/3 study testing preoperative chemo- and chemoradiotherapy and Surgical resection in people with Adenocarcinoma of the Gastroesophageal Junction, run by Medical University of Lublin at 1 site in Poland.
Trial summary
The high cancer related mortality has remained a significant issue of health care in Poland, Europe and worldwide. The decreasing incidence rate for carcinoma of the distal stomach and a marked trend of increasing incidence for adenocarcinoma of the esophago-gastric junction and esophagus has been observed in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Gastroesophageal Junction
- What is being tested?
- preoperative chemo- and chemoradiotherapy and Surgical resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2012to Dec 2020
- Phase
- Phase 2/3
- 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
- patients of both gender, aged more than 18, with histopathologically confirmed adenocarcinoma of the esophagogastric junction
- medically fit to undergo a major surgery with planned thoracotomy and in general condition allowing to tolerate chemo- or chemoradiotherapy (Karnofsky Performance Status ≥70, ECOG 0-1).
- Carcinoma of the esophagogastric junction defined as adenocarcinoma involving esophagogastric junction when its epicenter is localized within 5cm proximally or 5cm distally to the anatomical esophagogastric junction with subclassification to 3 topographic types (type I between 5cm and 1cm above; type II between 1cm above and 2cm below; type III between 2cm and 5cm below anatomic junction of the esophagus and the stomach).
- Potentially resectable, local or locoregional cancer with clinical staging cT2-4aN0-3M0.
- The intended number of randomized patients has been set as 100: 50 patients randomized to each therapeutic arm with assumption, that 80% of randomized patients will complete the treatment protocol.
Who cannot join
- disseminated cancer
- poor general condition (KI <70)
- adenocarcinoma of the stomach
- adenocarcinoma of the esophagus
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Second Department of General & Gastrointestinal Surgery & Oncological Surgery of the Alimantary Tract, Medical University of Lublin
Lublin, Lublin Voivodeship, 20-081
Tomasz Skoczylas, MD, PhD, +48 81 5328810, tomskocz@yahoo.com
Tomasz Skoczylas, MD, PhD
About this study
Official title: Efficacy and Safety Study of the Combined Modality Therapy in Patients With Potentially Resectable, Locally Advanced Adenocarcinoma of the Esophago-gastric Junction With Preoperative Chemo- and Chemoradiation Followed by Surgical Resection
The high cancer related mortality has remained a significant issue of health care in Poland, Europe and worldwide. The decreasing incidence rate for carcinoma of the distal stomach and a marked trend of increasing incidence for adenocarcinoma of the esophago-gastric junction and esophagus has been observed in the developed countries. The most eminent drawback of majority commonly cited randomized trials is heterogenicity of cancer patient population. The epidemiological, pathological, and clinical data clearly suggest that adenocarcinoma of the esophago-gastric junction is the entirety different both from adenocarcinoma of the esophagus and adenocarcinoma of the stomach. The experience in a combined modality therapy for adenocarcinoma of the esophago-gastric junction have been extrapolated from studies on esophageal or gastric cancer, where the investigated population involved in part patients with carcinoma of the esophago-gastric junction. The proposed study has been designed to achieve the following objectives:
- The assessment of safety and efficacy of a combined modality therapy in homogenous patient population with adenocarcinoma of the esophago-gastric junction excluding individuals with adenocarcinoma of the esophagus or the stomach;
- The assessment of safety of a combined modality therapy in a form of chemo- and chemoradiotherapy related toxicity and impact of chemo- and chemoradiotherapy on postoperative morbidity or mortality rates;
- The assessment of efficacy of a combined modality therapy in a form of rate of response of the tumor to chemo- and chemoradiotherapy and a curative resection rate.
- The assessment of efficacy of a combined modality therapy in a form of cancer free survival and overall survival.
Read the detailed description
Adenocarcinoma of the esophago-gastric junction (AEG) represents an aggressive disease with poor prognosis. Surgery is the traditional mainstay of treatment for patients presenting with locally advanced disease, defined as transmural invasion with or without lymph node involvement. Surgical approach may differ, but the principal is to achieve wide mural clearance, negative margins, and perform an adequate lymphadenectomy. Although surgery is the primary modality that can cure patients, the majority of patients reveal recurrence leading to death within 2 years after resection. The incidence of locoregional relapse in most series and in phase II and phase III trials ranges from 25% to 60%, and 20-30% of these patients have no evidence of distant metastases. Median survival with surgery alone for localized disease remains poor, and ranges from 13 to 19 months with 5-year survival rates at best approximately 40%. To improve a long-term outcome in patients with esophageal and gastric cancers a combined modality therapy concept has been investigating for many years. The experience in a combined modality therapy for adenocarcinoma of the esophago-gastric junction have been extrapolated from studies on esophageal or gastric cancer, where the investigated population involved in part patients with AEG.
The most eminent drawback of majority commonly cited randomized trials is heterogenicity of cancer patients population. Most of them overlap between esophageal adenocarcinoma and squamous cell carcinoma or between adenocarcinoma of the esophagus, esophagogastric junction and the stomach. When the investigators reviewed the composition of the most prominent 10 studies population including 3171 patients with easophageal and gastric cancer the investigators identified 911 (28.7%) patients with AEG. The remaining pooled population involved 1173 (36.9%) patients with adenocarcinoma of the esophagus, 598 (18.9%) patients with squamous cell carcinoma of the esophagus and 775 (24.4%) patients with adenocarcinoma of the stomach. Only 1 randomized controlled trial concerned exclusively patients with AEG. In this study preoperative chemoradiotherapy resulted in a 16% increase of 3-year survival. Although its superiority was not proven (p=0.07), these data provide evidence that preoperative chemoradiotherapy may improve survival and should be further investigated. Interestingly, the survival benefit was evident although the postoperative mortality was more than doubled (10.2% versus 3.8%) by adding chemotherapy. Although this study did not meet its accrual goals and could not provide statistical significance, the improvement in both local cancer free and overall survival suggest that preoperative chemoradiotherapy appears most valuable modality treatment to cure patients with localized AEG. As it is more than evident that major response to preoperative treatment is an important prognostic factor future trials should aim to optimize preoperative treatment by combining all treatment modalities.
All above mentioned discrepancies regarding the optimal treatment for AEG brought the investigators to an idea to design a study testing safety and efficacy of three-phase combined modality therapy accommodating induction taxane-based triple chemotherapy followed by concurrent chemoradiotherapy with 45Gy as a total dose of irradiation and subsequent surgical resection in homogenous population of patients with clearly defined AEG. Taking into account the results from recent phase II and III trials the proposed combined modality regimen suggests substantial response to the neoadjuvant therapy and promising highly effective loco-regional cancer clearance with moderate and acceptable tolerance despite a complex and extensive treatment.
- Being tested
- preoperative chemo- and chemoradiotherapy, Surgical resection
- Keywords
- Adenocarcinoma, esophago-gastric cancer, chemotherapy, chemoradiotherapy, surgery
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative chemo- and chemoradiotherapyOther
Also called docetaxel,, oxaliplatin,, 5-fluorouracil,, irradiation
2 cycles of triple regimen chemotherapy consisting of docetaxel (75mg/m2 iv infusion), oxaliplatin (130mg/m2 iv infusion) and 5-fluorouracil (750mg/m2 iv infusion followed by fractionated irradiation (total dose 45Gy in 25 fractions of 1,8Gy) combined with chemotherapy consisting of 3 cycles of 1-day chemotherapy with docetaxel (50mg/m2 iv infusion) and oxaliplatin (85mg/m2 iv infusion
Surgical resectionProcedure or surgery
Also called esophagectomy,, gastrectomy
The extent of surgery will be associated with the topographic type of carcinoma of the esophagogastric junction: type I - subtotal esophagectomy with superior gastric resection, splenectomy and two-field mediastinal lymph node dissection; type II and III - total gastrectomy with distal esophagectomy, splenectomy and D2 with mediastinal inferior lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| Combined therapy | Experimental | The combined modality therapy will be consisted of preoperative chemoradiotherapy (Docetaxel, Oxaliplatin, 5-Fluorouracil, 45Gy) for type I i II cancer or preoperative chemotherapy (Docetaxel, Oxaliplatin, 5-Fluorouracil) for type III cancer and followed by surgery. Receives: Other: preoperative chemo- and chemoradiotherapy |
| Surgery | Active comparator | The extent of surgery will be associated with the topographic type of carcinoma of the esophagogastric junction: type I - subtotal esophagectomy with superior gastric resection, splenectomy and two-field mediastinal lymph node dissection; type II and III - total gastrectomy with distal esophagectomy, splenectomy and D2 with mediastinal inferior lymph node dissection. Receives: Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response to treatment
Pathological response to treatment assessed as a tumor regresion grade in histopahological assessment of the surgical specimen
Measured: 6-12 weeks after chemoradiotherapy
Secondary outcomes (7)
Clinical response to treatment
Clinical response to treatment based on the modified RECIST criteria measured by CT
Measured: 5 weeks after chemoradiotherapy
The curative resection (R0) rate
The curative resection (R0) rate defined by the assessment of proximal, distal and circumferential margins
Measured: 6-12 weeks after chemoradiotherapy
chemoradiotherapy related toxicity
The rate and intensity of chemo- and chemoradiotherapy related toxicity
Measured: 6-12 weeks after chemoradiotherapy
postoperative complications rate
The rate and intensity of postoperative morbidity and mortality
Measured: 30 days after surgical resection
Overall and cancer free survival
Overall and cancer free survival
Measured: 5 years from onset of the chemoradiotherapy
Quality of life changes
Quality of life changes
Measured: 5 years after the onset of cheemoradiotherapy
The rate of chemo- and chemoradiotherapy dose reduction
The rate of dose reduction due to chemotherapy or radiotherapy related toxicity
Measured: 11 weeks during chemo- and chemoradiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the Gastroesophageal JunctionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Skoczylas, Medical University of Lublin
- Investigators
- Tomasz Skoczylas, MD, PhD, Principal investigator, Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of LublinGrzegorz Wallner, Professor, Principal investigator, Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of LublinAndrzej Dąbrowski, Professor, Principal investigator, Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of LublinWitold Zgodziński, MD, PhD, Principal investigator, Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of LublinMarek Majewski, MD, PhD, Principal investigator, Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of LublinMaria Mazurkiewicz, Professor, Principal investigator, Department of Oncology, Medical University of Lublin, Lublin Oncology CenterAnna Brzozowska, MD, PhD, Principal investigator, Department of Oncology, Medical University of Lublin, Lublin Oncology CenterLudmiła Grzybowska-Szatkowska, MD, PhD, Principal investigator, Department of Oncology, Medical University of Lublin, Lublin Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523015
- Sponsor's protocol ID
- EGC-0254/87/2011
- Other IDs
- UML-EGC-2011
- Status last verified
- Feb 2013
- First submitted
- 25 Jan 2012
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of the Combined Modality Therapy in Patients With Potentially Resectable, Locally Advanced Adenocarcinoma of the Esophago-gastric Junction With Preoperative Chemo- and Chemoradiation Followed by Surgical Resection
- ClinicalTrials.gov ID
- NCT01523015
- Acronym / sponsor ID
- EGC-0254/87/2011
- Keywords
- Adenocarcinoma, esophago-gastric cancer, chemotherapy, chemoradiotherapy, surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Feb 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.
The high cancer related mortality has remained a significant issue of health care in Poland, Europe and worldwide. The decreasing incidence rate for carcinoma of the distal stomach and a marked trend of increasing incidence for adenocarcinoma of the esophago-gastric junction and esophagus has been observed in the developed countries. The most eminent drawback of majority commonly cited randomized trials is heterogenicity of cancer patient population. The epidemiological, pathological, and clinical data clearly suggest that adenocarcinoma of the esophago-gastric junction is the entirety different both from adenocarcinoma of the esophagus and adenocarcinoma of the stomach. The experience in a combined modality therapy for adenocarcinoma of the esophago-gastric junction have been extrapolated from studies on esophageal or gastric cancer, where the investigated population involved in part patients with carcinoma of the esophago-gastric junction. The proposed study has been designed to achieve the following objectives:
- The assessment of safety and efficacy of a combined modality therapy in homogenous patient population with adenocarcinoma of the esophago-gastric junction excluding individuals with adenocarcinoma of the esophagus or the stomach;
- The assessment of safety of a combined modality therapy in a form of chemo- and chemoradiotherapy related toxicity and impact of chemo- and chemoradiotherapy on postoperative morbidity or mortality rates;
- The assessment of efficacy of a combined modality therapy in a form of rate of response of the tumor to chemo- and chemoradiotherapy and a curative resection rate.
- The assessment of efficacy of a combined modality therapy in a form of cancer free survival and overall survival.
Detailed description
Adenocarcinoma of the esophago-gastric junction (AEG) represents an aggressive disease with poor prognosis. Surgery is the traditional mainstay of treatment for patients presenting with locally advanced disease, defined as transmural invasion with or without lymph node involvement. Surgical approach may differ, but the principal is to achieve wide mural clearance, negative margins, and perform an adequate lymphadenectomy. Although surgery is the primary modality that can cure patients, the majority of patients reveal recurrence leading to death within 2 years after resection. The incidence of locoregional relapse in most series and in phase II and phase III trials ranges from 25% to 60%, and 20-30% of these patients have no evidence of distant metastases. Median survival with surgery alone for localized disease remains poor, and ranges from 13 to 19 months with 5-year survival rates at best approximately 40%. To improve a long-term outcome in patients with esophageal and gastric cancers a combined modality therapy concept has been investigating for many years. The experience in a combined modality therapy for adenocarcinoma of the esophago-gastric junction have been extrapolated from studies on esophageal or gastric cancer, where the investigated population involved in part patients with AEG.
The most eminent drawback of majority commonly cited randomized trials is heterogenicity of cancer patients population. Most of them overlap between esophageal adenocarcinoma and squamous cell carcinoma or between adenocarcinoma of the esophagus, esophagogastric junction and the stomach. When the investigators reviewed the composition of the most prominent 10 studies population including 3171 patients with easophageal and gastric cancer the investigators identified 911 (28.7%) patients with AEG. The remaining pooled population involved 1173 (36.9%) patients with adenocarcinoma of the esophagus, 598 (18.9%) patients with squamous cell carcinoma of the esophagus and 775 (24.4%) patients with adenocarcinoma of the stomach. Only 1 randomized controlled trial concerned exclusively patients with AEG. In this study preoperative chemoradiotherapy resulted in a 16% increase of 3-year survival. Although its superiority was not proven (p=0.07), these data provide evidence that preoperative chemoradiotherapy may improve survival and should be further investigated. Interestingly, the survival benefit was evident although the postoperative mortality was more than doubled (10.2% versus 3.8%) by adding chemotherapy. Although this study did not meet its accrual goals and could not provide statistical significance, the improvement in both local cancer free and overall survival suggest that preoperative chemoradiotherapy appears most valuable modality treatment to cure patients with localized AEG. As it is more than evident that major response to preoperative treatment is an important prognostic factor future trials should aim to optimize preoperative treatment by combining all treatment modalities.
All above mentioned discrepancies regarding the optimal treatment for AEG brought the investigators to an idea to design a study testing safety and efficacy of three-phase combined modality therapy accommodating induction taxane-based triple chemotherapy followed by concurrent chemoradiotherapy with 45Gy as a total dose of irradiation and subsequent surgical resection in homogenous population of patients with clearly defined AEG. Taking into account the results from recent phase II and III trials the proposed combined modality regimen suggests substantial response to the neoadjuvant therapy and promising highly effective loco-regional cancer clearance with moderate and acceptable tolerance despite a complex and extensive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined therapy | Experimental | Other: preoperative chemo- and chemoradiotherapyThe combined modality therapy will be consisted of preoperative chemoradiotherapy (Docetaxel, Oxaliplatin, 5-Fluorouracil, 45Gy) for type I i II cancer or preoperative chemotherapy (Docetaxel, Oxaliplatin, 5-Fluorouracil) for type III cancer and followed by surgery. |
| Surgery | Active comparator | Procedure: Surgical resectionThe extent of surgery will be associated with the topographic type of carcinoma of the esophagogastric junction: type I - subtotal esophagectomy with superior gastric resection, splenectomy and two-field mediastinal lymph node dissection; type II and III - total gastrectomy with distal esophagectomy, splenectomy and D2 with mediastinal inferior lymph node dissection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients of both gender, aged more than 18, with histopathologically confirmed adenocarcinoma of the esophagogastric junction
- medically fit to undergo a major surgery with planned thoracotomy and in general condition allowing to tolerate chemo- or chemoradiotherapy (Karnofsky Performance Status ≥70, ECOG 0-1).
- Carcinoma of the esophagogastric junction defined as adenocarcinoma involving esophagogastric junction when its epicenter is localized within 5cm proximally or 5cm distally to the anatomical esophagogastric junction with subclassification to 3 topographic types (type I between 5cm and 1cm above; type II between 1cm above and 2cm below; type III between 2cm and 5cm below anatomic junction of the esophagus and the stomach).
- Potentially resectable, local or locoregional cancer with clinical staging cT2-4aN0-3M0.
- The intended number of randomized patients has been set as 100: 50 patients randomized to each therapeutic arm with assumption, that 80% of randomized patients will complete the treatment protocol.
Key exclusion criteria (4 listed)
- disseminated cancer
- poor general condition (KI <70)
- adenocarcinoma of the stomach
- adenocarcinoma of the esophagus
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 |
|---|---|---|
| preoperative chemo- and chemoradiotherapyAlso: docetaxel,, oxaliplatin,, 5-fluorouracil,, irradiation2 cycles of triple regimen chemotherapy consisting of docetaxel (75mg/m2 iv infusion), oxaliplatin (130mg/m2 iv infusion) and 5-fluorouracil (750mg/m2 iv infusion followed by fractionated irradiation (total dose 45Gy in 25 fractions of 1,8Gy) combined with chemotherapy consisting of 3 cycles of 1-day chemotherapy with docetaxel (50mg/m2 iv infusion) and oxaliplatin (85mg/m2 iv infusion | Other | Combined therapy |
| Surgical resectionAlso: esophagectomy,, gastrectomyThe extent of surgery will be associated with the topographic type of carcinoma of the esophagogastric junction: type I - subtotal esophagectomy with superior gastric resection, splenectomy and two-field mediastinal lymph node dissection; type II and III - total gastrectomy with distal esophagectomy, splenectomy and D2 with mediastinal inferior lymph node dissection. | Procedure or surgery | Surgery |
Primary outcome
Pathological response to treatment
Time frame: 6-12 weeks after chemoradiotherapy
Pathological response to treatment assessed as a tumor regresion grade in histopahological assessment of the surgical specimen
7 secondary outcomes
Clinical response to treatment
Time frame: 5 weeks after chemoradiotherapy
The curative resection (R0) rate
Time frame: 6-12 weeks after chemoradiotherapy
chemoradiotherapy related toxicity
Time frame: 6-12 weeks after chemoradiotherapy
postoperative complications rate
Time frame: 30 days after surgical resection
Overall and cancer free survival
Time frame: 5 years from onset of the chemoradiotherapy
Quality of life changes
Time frame: 5 years after the onset of cheemoradiotherapy
The rate of chemo- and chemoradiotherapy dose reduction
Time frame: 11 weeks during chemo- and chemoradiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
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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.
Tomasz Skoczylas, MD, PhD principal investigator
Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
Grzegorz Wallner, Professor principal investigator
Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
Andrzej Dąbrowski, Professor principal investigator
Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing preoperative chemo- and chemoradiotherapy and Surgical resection in people with Adenocarcinoma of the Gastroesophageal Junction, run by Medical University of Lublin at 1 site in Poland.
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 5 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: status not confirmed, as of the sponsor's last update on 5 Feb 2013. 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 Poland. 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 combined 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.
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 Tomasz Skoczylas, MD, PhD (+48 81 5328810, tomskocz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological response to treatment (time frame: 6-12 weeks after chemoradiotherapy). 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 5 Feb 2013.