Esophageal CancerPhase 2/3NCT01704690
Combination Treatment of S-1 With Paclitaxel in Advanced Esophageal Cancer
A Phase 2/3 study testing S-1 and Paclitaxel, Paclitaxel and Cisplatin and 5-FU and Cisplatin in people with Esophageal Cancer, run by Peking University at 1 site in China.
Trial summary
Esophageal cancer is one of the common malignant disease, especially in China. The annual incidence of esophageal squamous cell carcinoma is 260,000 with the motility of 210,000. The prognosis of esophageal cancer is very poor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- S-1 and Paclitaxel, Paclitaxel and Cisplatin and 5-FU and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Mar 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have histologically confirmed diagnosis of esophageal cancer without prior palliative treatment or an interval of at least 6 months from the last operation, adjuvant radiation therapy and adjuvant chemotherapy. If patients received adjuvant chemotherapy, paclitaxel and cisplatin must be excluded from the regiment or the total dosage of cisplatin must be less than 300mg/m2.
- - Patients must be 18 to 75 years old and both genders are eligible.
- - Patients must have measurable or evaluable disease with at least one tumor mass maximum diameter ≥10mm by multi-slice spiral CT or MR scan. If ordinary CT scan is used the tumor mass maximum diameter must ≥ 2cm. Imaging exam must be performed within 15 days from enrollment.
- - Patients must have an expected life expectancy of ≥ 3 months
- - Patients must have a performance status of ≥ 80 on the Karnofsky scale
- - Patients must have normal marrow function and the blood tests must be collected within 7 days from enrollment with a hemoglobin (HGB) of ≥90g/L, an white blood cell (WBC) counts of ≥4.0×109/L，a neutrophil count of ≥2.0×109/L, , a platelet count of ≥100×109/L, a total bilirubin (TBil) of ≤1.0 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.0 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL, Alkaline phosphatase (AKP) ≤5.0 UNL. For patients with liver metastasis, the ASAT/ALAT must be ≤5.0 UNL.
Show all 9Show fewer
- - Patients must have normal electrocardiogram results and no history of congestive heart failure.
- - Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events.
- - Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors
Who cannot join
- Patients who have received prior palliative treatment or less than 6 months from the last operation, adjuvant radiotherapy, adjuvant chemotherapy.
- Previous treatment regiment involve paclitaxel and S-1
- Tumor mass >10mm by CT or MR scan. The total area of metastatic tumor lesions in liver is over 50% of whole liver or the total area of metastatic tumor lesions in lung is over 25% of whole lung.
- Patients without measurable or evaluable disease, for example cavity effusion or diffusive metastasis of organs.
- Patients with history of other tumors except for those of cervical carcinoma in situ or skin basal cell carcinoma who had been completely treated and without relapse in last 5 years.
- Patients with serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure.
Show all 10Show fewer
- Patients with only brain metastasis or bone metastasis
- Patients with chronic diarrhea
- Patients with neurological or psychiatric abnormalities including metastasis of the central nervous system that affect cognitive.
- Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment).
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Cancer Hospital, Peking University Cancer Hospital
Beijing, 100142
About this study
Official title: Combination Treatment of S-1 With Paclitaxel Versus Paclitaxel+Cisplatin and 5-Fu+Cisplatin as First-line Treatment in Advanced Esophageal Cancer
Esophageal cancer is one of the common malignant disease, especially in China. The annual incidence of esophageal squamous cell carcinoma is 260,000 with the motility of 210,000. The prognosis of esophageal cancer is very poor. About 50% of patients have advanced disease at diagnosis and the natural course is only 6-8 months with a 5-year survival rate of 5-7%. Though some patients received surgical treatment, disease will recurrent and metastasis in nearly 90% of the patients.
In past decades, there isn't much improvement of the outcome and survival of advanced esophageal cancer due to the lack of effective chemotherapy agents. The traditional chemotherapy drugs include 5-fluorouracil and cisplatin and the combination of them results in a 25-35% response rate in both first-line and palliative treatment. Paclitaxel plus cisplatin regiment is another promising treatment of esophageal cancer and have been proved effective in many studies. One of our previous study showed paclitaxel and cisplatin treatment resulted in encouraging response rate with manageable side-effects in 131 patients of advanced esophageal cancer.
Read more
However, the toxicities of paclitaxel and cisplatin limit their combination in clinic. For example, the polyoxyethylene castor oil paclitaxel could induce acute hypersensitivity reactions and neurotoxicity. Cisplatin could result in dysfunction of kidney and neurotoxicity. In addition, most of esophageal cancer patients are age 65 to 70. Many of them have simultaneously other diseases such as hypertension, diabetes, and chronic kidney disease which cause varying damages of renal function and limit the use of cisplatin in these patients. Therefore, it is urgent for doctors to seek an alternative of cisplatin in the combination chemotherapy treatment.
Therefore, the investigators designed this randomized clinical trial in which a novel combination of S-1 with paclitaxel is used to treat advanced esophageal cancer patients in compare with paclitaxel/cisplatin and 5-FU/cisplatin treatment to explore its efficacy and toxicity. The investigators hope this study will provide some clues for the treatment of esophageal cancer patients.
Read the detailed description
Esophageal cancer is one of the common malignant tumors, especially in China and the annual incidence of esophageal squamous cell carcinoma is 260,000 with the motility of 210,000. In western countries, the incidence of esophageal adenocarcinoma (esophageal - gastric junction carcinoma) now dramatically increased than in the past. The pathological types of highest incidences are changing from esophageal squamous cell carcinoma (Esophageal Squamous Cell Carcinoma, ESCC) to esophageal adenocarcinoma (Esophageal adenocarcinoma, EAC) whose incidence is about 60-70%. But in Asia, esophageal squamous cell carcinoma is still the dominant pathological type, accounting for more than 95%. The prognosis of esophageal cancer is very poor. About 50% of patients have advanced disease at diagnosis and the natural course is only 6-8 months with a 5-year survival rate of 5-7%. In addition, though some patients received surgical treatment, disease will recurrent and metastasis in nearly 90% of the patients. For those patients in early stage (T1), there are still nearly 50% of patients relapse within 5 years. Therefore, in recent years, doctors and researchers in different countries are continued to seek effective treatment to improve the quality of life of patients with esophageal cancer and prolong survival.
In past decades, there isn't much improvement of the outcome and survival of advanced esophageal cancer due to the lack of effective chemotherapy agents. The traditional chemotherapy drugs to treat esophageal cancer include 5 - fluorouracil and cisplatin and the combination of them results in a 25-35% response rate in both first-line and palliative treatment. And this combing is still the traditional chemotherapy regimens and wildly used in clinical studies to treat both esophageal gland, squamous cell carcinoma of the clinical study.
Paclitaxel plus cisplatin regiment is another promising treatment of esophageal cancer and have been proved effective in a lot of studies. This combination has become a standard treatment of esophageal cancer, especially the esophageal squamous cell carcinoma. In one of our previous study, paclitaxel and cisplatin treatment showed encouraging clinical results with manageable side-effects in 131 patients of advanced esophageal cancer. These investigations have fully proved the efficacy and feasibility of the combination of paclitaxel with cisplatin regiment in the treatment of esophageal cancer. However, the lower solubility of paclitaxel limited its direct intravenous use. To solve this problem, the paclitaxel must inject with an addition of the surfactant polyoxyethylene castor oil. Polyoxyethylene castor oil paclitaxel could induce high incidence of acute hypersensitivity reactions, ie. severe allergic reactions, kidney damage, and neurotoxicity and cardiovascular toxicity which is characterized by axonal degeneration and demyelination. Though proper preventive treatment will greatly reduce the incidence of allergy, there are still a small number of patients have allergy reaction.
As the investigators all know, the main adverse of cisplatin is the renal toxicity. The peak age of esophageal cancer patients are age 65 to 70 and many of them have simultaneously other diseases such as hypertension, diabetes, and chronic kidney disease which cause varying damages of renal function and limit the use of cisplatin in these patients. Therefore, it is urgent and crucial for doctors to seek an alternative of cisplatin in the combination chemotherapy treatment. There haven't well designed large scale clinical trials to evidence the non-platinum treatment in esophageal cancer. Therefore, the investigators designed this randomized clinical trial in which a novel combination of S-1 with paclitaxel is used to treat advanced esophageal cancer patients in compare with paclitaxel/cisplatin and 5-FU/cisplatin treatment to explore its efficacy and toxicity. The investigators hope this study will provide some clues for the treatment of esophageal cancer patients.
- Conditions
- Esophageal Cancer
- Being tested
- S-1 and Paclitaxel, Paclitaxel and Cisplatin, 5-FU and Cisplatin
- Keywords
- Esophageal cancer, Chemotherapy, Efficacy, Toxicity
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1 and PaclitaxelDrug
Also called TEYSUNO, TAXOL
S-1 and Paclitaxel are used in the S-1 and Paclitaxel arm.
Paclitaxel and CisplatinDrug
Also called TAXOL, PLATINOL
The paclitaxel and cisplatin combination will be used in the Paclitaxel and Cisplatin arm.
5-FU and CisplatinDrug
Also called 5-fluorouracil, PLATINOL
The cisplatin and 5-fluorouracil combination will be used in the Cisplatin and 5-FU arm.
| Study group | Role | What they receive |
|---|---|---|
| S-1 and Paclitaxel | Experimental | Patients in these arm will receive combination treatment of S-1 and paclitaxel. S-1, 80-120mg po, bid, from day 1 to day 14 Paclitaxel, 175mg/m2, IV infusion on day 1 Repeated every 21 days Receives: Drug: S-1 and Paclitaxel |
| Paclitaxel and Cisplatin | Active comparator | Patients in these arm will receive combination treatment of paclitaxel and cisplatin.
Paclitaxel, 175mg/m2, IV infusion on day 1 Cisplatin, 30 mg/m2, IV infusion on day 1 and day 2 Repeated every 21 days Receives: Drug: Paclitaxel and Cisplatin |
| 5-FU and Cisplatin | Active comparator | Patients in these arm will receive combination treatment of 5-FU and cisplatin. 5-FU, 2500mg/m2, continue iv infusion for 120 hours Cisplatin, 35 mg/m2, IV infusion on day 1 and day 2 Repeated every 21 days Receives: Drug: 5-FU and Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
The disease control rate (DCR) will be evaluated every 2 cycles (average 6 weeks) of treatment according to the RECIST 1.0 criteria until disease progression or finishing all 6 cycles of treatment.
Measured: Every 2 cycles of treatment (average 6 weeks) up to 6cycles (assessed 18 weeks)
Secondary outcomes (3)
The median overall survival time
All the participants will receive chemotherapy very 3 weeks until disease progression. And after all 6 cycles of treatment, patients will be followed every 3 months until death from any cause or lost to follow up (up to 36 months). The median overall survival time will be measured using SPSS software version 17.0.
Measured: From date of randomization until the date of death from any cause (assessed up to 36 months)
Median progression-free time
All the participants will receive chemotherapy very 3 weeks until disease progression and the response will be evaluated every 2 cycles (about 6 weeks). And after all 6 cycles of treatment, patients will be followed and re-evaluated every 3 months until disease progression or death from any cause (up to 36 months). The median progression-free survival time will be measured using SPSS software version 17.0.
Measured: From date of randomization until the date of first documented progression or death from any cause (assessed up tp 36 months)
Number of Participants with Adverse Events and the degree of each adverse event
Both the number of subjects with adverse events and the degree of the adverse events of each participant according to NCI CTCAE version 3.0 will be recorded. And the outcome of each adverse event will be followed. The rate of adverse events will be compared in different arms.
Measured: Participants will be followed every week during treatment and every 3 months during follow-up time (assessed up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: The enrollment of the study is much slower than expected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodong Zhang, Peking University
- Investigators
- Xiaodong Zhang, MD, Principal investigator, Beijing Cancer Hospital, Peking University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704690
- Sponsor's protocol ID
- ESCC001
- Status last verified
- Apr 2017
- First submitted
- 4 Oct 2012
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Devesa SS, Blot WJ, Fraumeni JF Jr. Changing patterns in the incidence of esophageal and gastric carcinoma in the United States. Cancer. 1998 Nov 15;83(10):2049-53.
PubMed 9827707Bollschweiler E, Wolfgarten E, Gutschow C, Holscher AH. Demographic variations in the rising incidence of esophageal adenocarcinoma in white males. Cancer. 2001 Aug 1;92(3):549-55. doi: 10.1002/1097-0142(20010801)92:33.0.co;2-l.
PubMed 11505399Ilson DH. Oesophageal cancer: new developments in systemic therapy. Cancer Treat Rev. 2003 Dec;29(6):525-32. doi: 10.1016/s0305-7372(03)00104-x.
PubMed 14585262Anderson SE, Minsky BD, Bains M, Kelsen DP, Ilson DH. Combined modality therapy in esophageal cancer: the Memorial experience. Semin Surg Oncol. 2003;21(4):228-32. doi: 10.1002/ssu.10041.
PubMed 14648780Scheithauer W. Esophageal cancer: chemotherapy as palliative therapy. Ann Oncol. 2004;15 Suppl 4:iv97-100. doi: 10.1093/annonc/mdh911. No abstract available.
PubMed 15477344Koshy M, Esiashvilli N, Landry JC, Thomas CR Jr, Matthews RH. Multiple management modalities in esophageal cancer: combined modality management approaches. Oncologist. 2004;9(2):147-59. doi: 10.1634/theoncologist.9-2-147.
PubMed 15047919Westerterp M, Koppert LB, Buskens CJ, Tilanus HW, ten Kate FJ, Bergman JJ, Siersema PD, van Dekken H, van Lanschot JJ. Outcome of surgical treatment for early adenocarcinoma of the esophagus or gastro-esophageal junction. Virchows Arch. 2005 May;446(5):497-504. doi: 10.1007/s00428-005-1243-1. Epub 2005 Apr 19.
PubMed 15838647Enzinger PC, Ilson DH, Kelsen DP. Chemotherapy in esophageal cancer. Semin Oncol. 1999 Oct;26(5 Suppl 15):12-20.
PubMed 10566606Bleiberg H, Conroy T, Paillot B, Lacave AJ, Blijham G, Jacob JH, Bedenne L, Namer M, De Besi P, Gay F, Collette L, Sahmoud T. Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell oesophageal cancer. Eur J Cancer. 1997 Jul;33(8):1216-20. doi: 10.1016/s0959-8049(97)00088-9.
PubMed 9301445Ilson DH, Forastiere A, Arquette M, Costa F, Heelan R, Huang Y, Kelsen DP. A phase II trial of paclitaxel and cisplatin in patients with advanced carcinoma of the esophagus. Cancer J. 2000 Sep-Oct;6(5):316-23.
PubMed 11079171Polee MB, Tilanus HW, Eskens FA, Hoekstra R, Van der Burg ME, Siersema PD, Stoter G, Van der Gaast A. Phase II study of neo-adjuvant chemotherapy with paclitaxel and cisplatin given every 2 weeks for patients with a resectable squamous cell carcinoma of the esophagus. Ann Oncol. 2003 Aug;14(8):1253-7. doi: 10.1093/annonc/mdg328.
PubMed 12881388Mu L, Feng SS. A novel controlled release formulation for the anticancer drug paclitaxel (Taxol): PLGA nanoparticles containing vitamin E TPGS. J Control Release. 2003 Jan 9;86(1):33-48. doi: 10.1016/s0168-3659(02)00320-6.
PubMed 12490371Mu L, Feng SS. Vitamin E TPGS used as emulsifier in the solvent evaporation/extraction technique for fabrication of polymeric nanospheres for controlled release of paclitaxel (Taxol). J Control Release. 2002 Apr 23;80(1-3):129-44. doi: 10.1016/s0168-3659(02)00025-1.
PubMed 11943393Lundberg BB, Risovic V, Ramaswamy M, Wasan KM. A lipophilic paclitaxel derivative incorporated in a lipid emulsion for parenteral administration. J Control Release. 2003 Jan 9;86(1):93-100. doi: 10.1016/s0168-3659(02)00323-1.
PubMed 12490375
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Treatment of S-1 With Paclitaxel Versus Paclitaxel+Cisplatin and 5-Fu+Cisplatin as First-line Treatment in Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01704690
- Acronym / sponsor ID
- ESCC001
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal cancer, Chemotherapy, Efficacy, Toxicity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The enrollment of the study is much slower than expected.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 11 Oct 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.
Esophageal cancer is one of the common malignant disease, especially in China. The annual incidence of esophageal squamous cell carcinoma is 260,000 with the motility of 210,000. The prognosis of esophageal cancer is very poor. About 50% of patients have advanced disease at diagnosis and the natural course is only 6-8 months with a 5-year survival rate of 5-7%. Though some patients received surgical treatment, disease will recurrent and metastasis in nearly 90% of the patients.
In past decades, there isn't much improvement of the outcome and survival of advanced esophageal cancer due to the lack of effective chemotherapy agents. The traditional chemotherapy drugs include 5-fluorouracil and cisplatin and the combination of them results in a 25-35% response rate in both first-line and palliative treatment. Paclitaxel plus cisplatin regiment is another promising treatment of esophageal cancer and have been proved effective in many studies. One of our previous study showed paclitaxel and cisplatin treatment resulted in encouraging response rate with manageable side-effects in 131 patients of advanced esophageal cancer.
However, the toxicities of paclitaxel and cisplatin limit their combination in clinic. For example, the polyoxyethylene castor oil paclitaxel could induce acute hypersensitivity reactions and neurotoxicity. Cisplatin could result in dysfunction of kidney and neurotoxicity. In addition, most of esophageal cancer patients are age 65 to 70. Many of them have simultaneously other diseases such as hypertension, diabetes, and chronic kidney disease which cause varying damages of renal function and limit the use of cisplatin in these patients. Therefore, it is urgent for doctors to seek an alternative of cisplatin in the combination chemotherapy treatment.
Therefore, the investigators designed this randomized clinical trial in which a novel combination of S-1 with paclitaxel is used to treat advanced esophageal cancer patients in compare with paclitaxel/cisplatin and 5-FU/cisplatin treatment to explore its efficacy and toxicity. The investigators hope this study will provide some clues for the treatment of esophageal cancer patients.
Detailed description
Esophageal cancer is one of the common malignant tumors, especially in China and the annual incidence of esophageal squamous cell carcinoma is 260,000 with the motility of 210,000. In western countries, the incidence of esophageal adenocarcinoma (esophageal - gastric junction carcinoma) now dramatically increased than in the past. The pathological types of highest incidences are changing from esophageal squamous cell carcinoma (Esophageal Squamous Cell Carcinoma, ESCC) to esophageal adenocarcinoma (Esophageal adenocarcinoma, EAC) whose incidence is about 60-70%. But in Asia, esophageal squamous cell carcinoma is still the dominant pathological type, accounting for more than 95%. The prognosis of esophageal cancer is very poor. About 50% of patients have advanced disease at diagnosis and the natural course is only 6-8 months with a 5-year survival rate of 5-7%. In addition, though some patients received surgical treatment, disease will recurrent and metastasis in nearly 90% of the patients. For those patients in early stage (T1), there are still nearly 50% of patients relapse within 5 years. Therefore, in recent years, doctors and researchers in different countries are continued to seek effective treatment to improve the quality of life of patients with esophageal cancer and prolong survival.
In past decades, there isn't much improvement of the outcome and survival of advanced esophageal cancer due to the lack of effective chemotherapy agents. The traditional chemotherapy drugs to treat esophageal cancer include 5 - fluorouracil and cisplatin and the combination of them results in a 25-35% response rate in both first-line and palliative treatment. And this combing is still the traditional chemotherapy regimens and wildly used in clinical studies to treat both esophageal gland, squamous cell carcinoma of the clinical study.
Paclitaxel plus cisplatin regiment is another promising treatment of esophageal cancer and have been proved effective in a lot of studies. This combination has become a standard treatment of esophageal cancer, especially the esophageal squamous cell carcinoma. In one of our previous study, paclitaxel and cisplatin treatment showed encouraging clinical results with manageable side-effects in 131 patients of advanced esophageal cancer. These investigations have fully proved the efficacy and feasibility of the combination of paclitaxel with cisplatin regiment in the treatment of esophageal cancer. However, the lower solubility of paclitaxel limited its direct intravenous use. To solve this problem, the paclitaxel must inject with an addition of the surfactant polyoxyethylene castor oil. Polyoxyethylene castor oil paclitaxel could induce high incidence of acute hypersensitivity reactions, ie. severe allergic reactions, kidney damage, and neurotoxicity and cardiovascular toxicity which is characterized by axonal degeneration and demyelination. Though proper preventive treatment will greatly reduce the incidence of allergy, there are still a small number of patients have allergy reaction.
As the investigators all know, the main adverse of cisplatin is the renal toxicity. The peak age of esophageal cancer patients are age 65 to 70 and many of them have simultaneously other diseases such as hypertension, diabetes, and chronic kidney disease which cause varying damages of renal function and limit the use of cisplatin in these patients. Therefore, it is urgent and crucial for doctors to seek an alternative of cisplatin in the combination chemotherapy treatment. There haven't well designed large scale clinical trials to evidence the non-platinum treatment in esophageal cancer. Therefore, the investigators designed this randomized clinical trial in which a novel combination of S-1 with paclitaxel is used to treat advanced esophageal cancer patients in compare with paclitaxel/cisplatin and 5-FU/cisplatin treatment to explore its efficacy and toxicity. The investigators hope this study will provide some clues for the treatment of esophageal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| S-1 and Paclitaxel | Experimental | Drug: S-1 and PaclitaxelPatients in these arm will receive combination treatment of S-1 and paclitaxel. S-1, 80-120mg po, bid, from day 1 to day 14 Paclitaxel, 175mg/m2, IV infusion on day 1 Repeated every 21 days |
| Paclitaxel and Cisplatin | Active comparator | Drug: Paclitaxel and CisplatinPatients in these arm will receive combination treatment of paclitaxel and cisplatin. Paclitaxel, 175mg/m2, IV infusion on day 1 Cisplatin, 30 mg/m2, IV infusion on day 1 and day 2 Repeated every 21 days |
| 5-FU and Cisplatin | Active comparator | Drug: 5-FU and CisplatinPatients in these arm will receive combination treatment of 5-FU and cisplatin. 5-FU, 2500mg/m2, continue iv infusion for 120 hours Cisplatin, 35 mg/m2, IV infusion on day 1 and day 2 Repeated every 21 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who have histologically confirmed diagnosis of esophageal cancer without prior palliative treatment or an interval of at least 6 months from the last operation, adjuvant radiation therapy and adjuvant chemotherapy. If patients received adjuvant chemotherapy, paclitaxel and cisplatin must be excluded from the regiment or the total dosage of cisplatin must be less than 300mg/m2.
- - Patients must be 18 to 75 years old and both genders are eligible.
- - Patients must have measurable or evaluable disease with at least one tumor mass maximum diameter ≥10mm by multi-slice spiral CT or MR scan. If ordinary CT scan is used the tumor mass maximum diameter must ≥ 2cm. Imaging exam must be performed within 15 days from enrollment.
- - Patients must have an expected life expectancy of ≥ 3 months
- - Patients must have a performance status of ≥ 80 on the Karnofsky scale
Key exclusion criteria (10 listed)
- Patients who have received prior palliative treatment or less than 6 months from the last operation, adjuvant radiotherapy, adjuvant chemotherapy.
- Previous treatment regiment involve paclitaxel and S-1
- Tumor mass >10mm by CT or MR scan. The total area of metastatic tumor lesions in liver is over 50% of whole liver or the total area of metastatic tumor lesions in lung is over 25% of whole lung.
- Patients without measurable or evaluable disease, for example cavity effusion or diffusive metastasis of organs.
- Patients with history of other tumors except for those of cervical carcinoma in situ or skin basal cell carcinoma who had been completely treated and without relapse in last 5 years.
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 |
|---|---|---|
| S-1 and PaclitaxelAlso: TEYSUNO, TAXOLS-1 and Paclitaxel are used in the S-1 and Paclitaxel arm. | Drug | S-1 and Paclitaxel |
| Paclitaxel and CisplatinAlso: TAXOL, PLATINOLThe paclitaxel and cisplatin combination will be used in the Paclitaxel and Cisplatin arm. | Drug | Paclitaxel and Cisplatin |
| 5-FU and CisplatinAlso: 5-fluorouracil, PLATINOLThe cisplatin and 5-fluorouracil combination will be used in the Cisplatin and 5-FU arm. | Drug | 5-FU and Cisplatin |
Primary outcome
Response rate
Time frame: Every 2 cycles of treatment (average 6 weeks) up to 6cycles (assessed 18 weeks)
The disease control rate (DCR) will be evaluated every 2 cycles (average 6 weeks) of treatment according to the RECIST 1.0 criteria until disease progression or finishing all 6 cycles of treatment.
3 secondary outcomes
The median overall survival time
Time frame: From date of randomization until the date of death from any cause (assessed up to 36 months)
Median progression-free time
Time frame: From date of randomization until the date of first documented progression or death from any cause (assessed up tp 36 months)
Number of Participants with Adverse Events and the degree of each adverse event
Time frame: Participants will be followed every week during treatment and every 3 months during follow-up time (assessed up to 1 year)
Results and safety
The study was stopped early (reason given: The enrollment of the study is much slower than expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Background: PubMed 9827707Devesa SS, Blot WJ, Fraumeni JF Jr. Changing patterns in the incidence of esophageal and gastric carcinoma in the United States. Cancer. 1998 Nov 15;83(10):2049-53.
- Background: PubMed 11505399Bollschweiler E, Wolfgarten E, Gutschow C, Holscher AH. Demographic variations in the rising incidence of esophageal adenocarcinoma in white males. Cancer. 2001 Aug 1;92(3):549-55. doi: 10.1002/1097-0142(20010801)92:33.0.co;2-l.
- Background: PubMed 14585262Ilson DH. Oesophageal cancer: new developments in systemic therapy. Cancer Treat Rev. 2003 Dec;29(6):525-32. doi: 10.1016/s0305-7372(03)00104-x.
- Background: PubMed 14648780Anderson SE, Minsky BD, Bains M, Kelsen DP, Ilson DH. Combined modality therapy in esophageal cancer: the Memorial experience. Semin Surg Oncol. 2003;21(4):228-32. doi: 10.1002/ssu.10041.
- Background: PubMed 15477344Scheithauer W. Esophageal cancer: chemotherapy as palliative therapy. Ann Oncol. 2004;15 Suppl 4:iv97-100. doi: 10.1093/annonc/mdh911. No abstract available.
- Background: PubMed 15047919Koshy M, Esiashvilli N, Landry JC, Thomas CR Jr, Matthews RH. Multiple management modalities in esophageal cancer: combined modality management approaches. Oncologist. 2004;9(2):147-59. doi: 10.1634/theoncologist.9-2-147.
- Background: PubMed 15838647Westerterp M, Koppert LB, Buskens CJ, Tilanus HW, ten Kate FJ, Bergman JJ, Siersema PD, van Dekken H, van Lanschot JJ. Outcome of surgical treatment for early adenocarcinoma of the esophagus or gastro-esophageal junction. Virchows Arch. 2005 May;446(5):497-504. doi: 10.1007/s00428-005-1243-1. Epub 2005 Apr 19.
- Background: PubMed 10566606Enzinger PC, Ilson DH, Kelsen DP. Chemotherapy in esophageal cancer. Semin Oncol. 1999 Oct;26(5 Suppl 15):12-20.
- Background: PubMed 9301445Bleiberg H, Conroy T, Paillot B, Lacave AJ, Blijham G, Jacob JH, Bedenne L, Namer M, De Besi P, Gay F, Collette L, Sahmoud T. Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell oesophageal cancer. Eur J Cancer. 1997 Jul;33(8):1216-20. doi: 10.1016/s0959-8049(97)00088-9.
- Background: PubMed 11079171Ilson DH, Forastiere A, Arquette M, Costa F, Heelan R, Huang Y, Kelsen DP. A phase II trial of paclitaxel and cisplatin in patients with advanced carcinoma of the esophagus. Cancer J. 2000 Sep-Oct;6(5):316-23.
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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.
Xiaodong Zhang, MD principal investigator
Beijing Cancer Hospital, Peking University Cancer Hospital
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 S-1 and Paclitaxel, Paclitaxel and Cisplatin and 5-FU and Cisplatin in people with Esophageal Cancer, run by Peking University at 1 site in China.
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 10 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 7 Apr 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 China. 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?
The study was stopped early (reason given: The enrollment of the study is much slower than expected.). 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?
Response rate (time frame: Every 2 cycles of treatment (average 6 weeks) up to 6cycles (assessed 18 weeks)). 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 NCT01704690, which also lists 14 linked publications.
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 7 Apr 2017.