Esophageal NeoplasmsPhase 3NCT00559351
RCT on the Combined Modality Treatment of Squamous Cell Carcinoma of the Esophagus
A Phase 3 study testing transthoracic esophagectomy 2-field extended lymphadenectomy, neoadjuvant chemotherapy (cisplatin, 5-fluorouracil) and neoadjuvant chemoradiotherapy in people with Esophageal Neoplasms and Squamous Cell Cancer, run by Ministry of Scientific Research and Information Technology, Poland at 1 site in Poland.
Trial summary
The purpose of the study was to test a null hypothesis that a combined modality treatment of esophageal cancer with neoadjuvant chemotherapy or chemoradiotherapy is equivalent to surgery alone and what are the benefits from adding irradiation to chemotherapy in neoadjuvant treatment of esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Neoplasms, Squamous Cell Cancer
- What is being tested?
- transthoracic esophagectomy 2-field extended lymphadenectomy, neoadjuvant chemotherapy (cisplatin, 5-fluorouracil) and neoadjuvant chemoradiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2001to Apr 2004
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Histopathologically proven, clinically stage II-III (cTNM according to AJCC/UICC classification), primary squamous cell carcinoma of the thoracic esophagus
- Patients' age above 18 years
- General condition with Karnofsky performance status of >70
- Circulatory and pulmonary capacity at normal range (FEV1 >60%; FVC >60%, NYHA I-II, cardiac output >40%)
- Normal function of the bone marrow (RBC >3,5 T/l; PLT >100 G/l)
- Normal renal (creatinine <1.5 of the upper limit) and liver (AST or ALT <2,5 of the upper limit or bilirubin <1,5 of the upper limit) function
Who cannot join
- Metastatic disease
- Synchronous malignancy
- History of other cancer within 5 years prior to esophageal cancer treatment
- History of allergic reaction to cisplatin of 5-fluorouracil
- Systemic infection
- Pregnancy or female patients in childbearing age without proper contraceptives.
Trial locations and contacts
1 site in 1 country.
Poland1 site
2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland
Lublin, Lublin Voivodeship, 20-081
About this study
Official title: Possibilities for Improvement of an Outcome of the Treatment in Squamous Cell Carcinoma of the Thoracic Esophagus - a Multicenter Randomized Clinical Phase III Trial.
The purpose of the study was to test a null hypothesis that a combined modality treatment of esophageal cancer with neoadjuvant chemotherapy or chemoradiotherapy is equivalent to surgery alone and what are the benefits from adding irradiation to chemotherapy in neoadjuvant treatment of esophageal cancer.
Read the detailed description
The choice of the most beneficial method of treatment in esophageal cancer remains controversial and is the subject of vigorous debate. Surgery is still regarded as the principle modality among treatment strategies, with longterm survival achieved mainly in less advanced cases. More advanced cases, diagnosed more frequently, are more problematic in selection of the optimal therapeutic method. One of the options for improving treatment outcome in patients with advanced esophageal cancer is combined modality treatment with chemo- and chemoradiotherapy. Currently available RCTs have tested preoperative chemotherapy or chemoradiotherapy separately in comparison to surgery alone. Moreover, we do not know from these trials what is the added value of irradiation in a combined modality therapy over a preoperative chemotherapy. Another drawback of available RCTs is combining 2 different biological cancer entities: adenocarcinoma and squamous cell carcinoma of the esophagus as well as carcinoma of the esophagus and gastro-esophageal junction. That were the reasons for designing our trial testing 3 principal modes of esophageal cancer therapy: surgery vs. chemotherapy + surgery vs. chemoradiotherapy + surgery on homogenous population of esophageal cancer patients with single pathological type - squamous cell carcinoma affecting thoracic esophagus.
- Conditions
- Esophageal Neoplasms, Squamous Cell Cancer
- Being tested
- transthoracic esophagectomy 2-field extended lymphadenectomy, neoadjuvant chemotherapy (cisplatin, 5-fluorouracil), neoadjuvant chemoradiotherapy
- Keywords
- esophagectomy, chemotherapy, chemoradiotherapy, combined modality therapy
- Medical subject headings
- Esophageal Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic esophagectomy 2-field extended lymphadenectomyProcedure or surgery
right thoracotomy, mobilization of the esophagus, mediastinal lymph node dissection, laparotomy, gastric tube formation, abdominal lymph node dissection, anastomosis in the neck
neoadjuvant chemotherapy (cisplatin, 5-fluorouracil)Drug
21-day combination systemic chemotherapy regimen consisted of a continuous infusion of cisplatin (20mg/m2/day) on days 1-5, 17-21 and 5-fluorouracil at 300mg/m2/day on days 1-21 followed by 3-phase transthoracic esophagectomy with 2-field extended lymphadenectomy after 3 week interval
neoadjuvant chemoradiotherapyRadiation
21-day combination systemic chemotherapy regimen consisted of a continuous infusion of cisplatin (20mg/m2/day) on days 1-5, 17-21 and 5-fluorouracil at 300mg/m2/day on days 1-21 with concurrent external beam fractionated irradiation to a total dose of 30Gy (2Gy fractions on days 1-5, 8-12, 15-19) followed by 3-phase transthoracic esophagectomy with 2-field extended lymphadenectomy after 3 week interval
| Study group | Role | What they receive |
|---|---|---|
| S | Active comparator | esophagectomy Receives: Procedure: transthoracic esophagectomy 2-field extended lymphadenectomy |
| CHTS | Experimental | neoadjuvant chemotherapy followed by esophagectomy Receives: Drug: neoadjuvant chemotherapy (cisplatin, 5-fluorouracil) |
| CHRTS | Experimental | neoadjuvant chemoradiotherapy followed by esophagectomy Receives: Radiation: neoadjuvant chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean, median, 1-year, 3-year, 5-year overall survival
Measured: 5 years
Secondary outcomes (4)
toxicity-related morbidity and mortality
Measured: 30-day
postoperative morbidity and mortality
Measured: 30-day
clinical and pathological response rates
Measured: 60-day
curative resection rate
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startDec 2001
- Study completionApr 2004
Why it stopped: difficulty in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Scientific Research and Information Technology, Poland
- Sponsor type
- Other government
- Investigators
- Grzegorz Wallner, MD, PhD, Principal investigator, 2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559351
- Sponsor's protocol ID
- 6P05C01320
- Other IDs
- PL SCSR 6P05C01320
- Status last verified
- Sep 2007
- First submitted
- 15 Nov 2007
- Last updated
- 16 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possibilities for Improvement of an Outcome of the Treatment in Squamous Cell Carcinoma of the Thoracic Esophagus - a Multicenter Randomized Clinical Phase III Trial.
- ClinicalTrials.gov ID
- NCT00559351
- Acronym / sponsor ID
- 6P05C01320
- Conditions
- Esophageal Neoplasms, Squamous Cell Cancer
- Keywords
- esophagectomy, chemotherapy, chemoradiotherapy, combined modality therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in recruitment
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ministry of Scientific Research and Information Technology, PolandOther government
- Study start
- Dec 2001
- Study completion
- Apr 2004 (actual)
- First posted
- 16 Nov 2007 (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 purpose of the study was to test a null hypothesis that a combined modality treatment of esophageal cancer with neoadjuvant chemotherapy or chemoradiotherapy is equivalent to surgery alone and what are the benefits from adding irradiation to chemotherapy in neoadjuvant treatment of esophageal cancer.
Detailed description
The choice of the most beneficial method of treatment in esophageal cancer remains controversial and is the subject of vigorous debate. Surgery is still regarded as the principle modality among treatment strategies, with longterm survival achieved mainly in less advanced cases. More advanced cases, diagnosed more frequently, are more problematic in selection of the optimal therapeutic method. One of the options for improving treatment outcome in patients with advanced esophageal cancer is combined modality treatment with chemo- and chemoradiotherapy. Currently available RCTs have tested preoperative chemotherapy or chemoradiotherapy separately in comparison to surgery alone. Moreover, we do not know from these trials what is the added value of irradiation in a combined modality therapy over a preoperative chemotherapy. Another drawback of available RCTs is combining 2 different biological cancer entities: adenocarcinoma and squamous cell carcinoma of the esophagus as well as carcinoma of the esophagus and gastro-esophageal junction. That were the reasons for designing our trial testing 3 principal modes of esophageal cancer therapy: surgery vs. chemotherapy + surgery vs. chemoradiotherapy + surgery on homogenous population of esophageal cancer patients with single pathological type - squamous cell carcinoma affecting thoracic esophagus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| S | Active comparator | Procedure: transthoracic esophagectomy 2-field extended lymphadenectomyesophagectomy |
| CHTS | Experimental | Drug: neoadjuvant chemotherapy (cisplatin, 5-fluorouracil)neoadjuvant chemotherapy followed by esophagectomy |
| CHRTS | Experimental | Radiation: neoadjuvant chemoradiotherapyneoadjuvant chemoradiotherapy followed by esophagectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent
- Histopathologically proven, clinically stage II-III (cTNM according to AJCC/UICC classification), primary squamous cell carcinoma of the thoracic esophagus
- Patients' age above 18 years
- General condition with Karnofsky performance status of >70
- Circulatory and pulmonary capacity at normal range (FEV1 >60%; FVC >60%, NYHA I-II, cardiac output >40%)
Key exclusion criteria (6 listed)
- Metastatic disease
- Synchronous malignancy
- History of other cancer within 5 years prior to esophageal cancer treatment
- History of allergic reaction to cisplatin of 5-fluorouracil
- Systemic infection
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 |
|---|---|---|
| transthoracic esophagectomy 2-field extended lymphadenectomyright thoracotomy, mobilization of the esophagus, mediastinal lymph node dissection, laparotomy, gastric tube formation, abdominal lymph node dissection, anastomosis in the neck | Procedure or surgery | S |
| neoadjuvant chemotherapy (cisplatin, 5-fluorouracil)21-day combination systemic chemotherapy regimen consisted of a continuous infusion of cisplatin (20mg/m2/day) on days 1-5, 17-21 and 5-fluorouracil at 300mg/m2/day on days 1-21 followed by 3-phase transthoracic esophagectomy with 2-field extended lymphadenectomy after 3 week interval | Drug | CHTS |
| neoadjuvant chemoradiotherapy21-day combination systemic chemotherapy regimen consisted of a continuous infusion of cisplatin (20mg/m2/day) on days 1-5, 17-21 and 5-fluorouracil at 300mg/m2/day on days 1-21 with concurrent external beam fractionated irradiation to a total dose of 30Gy (2Gy fractions on days 1-5, 8-12, 15-19) followed by 3-phase transthoracic esophagectomy with 2-field extended lymphadenectomy after 3 week interval | Radiation | CHRTS |
Primary outcome
mean, median, 1-year, 3-year, 5-year overall survival
Time frame: 5 years
4 secondary outcomes
toxicity-related morbidity and mortality
Time frame: 30-day
postoperative morbidity and mortality
Time frame: 30-day
clinical and pathological response rates
Time frame: 60-day
curative resection rate
Time frame: 30-day
Results and safety
The study was stopped early (reason given: difficulty in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2007.
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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.
Grzegorz Wallner, MD, PhD principal investigator
2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland
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 transthoracic esophagectomy 2-field extended lymphadenectomy, neoadjuvant chemotherapy (cisplatin, 5-fluorouracil) and neoadjuvant chemoradiotherapy in people with Esophageal Neoplasms and Squamous Cell Cancer, run by Ministry of Scientific Research and Information Technology, Poland 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 7 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: stopped early, as of the sponsor's last update on 16 Nov 2007. 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 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?
The study was stopped early (reason given: difficulty in recruitment). Results are not available in the source record.
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?
mean, median, 1-year, 3-year, 5-year overall survival (time frame: 5 years). 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 16 Nov 2007.