Esophageal Squamous Cell CarcinomaPhase 3NCT02465736
Study of Docetaxel or Vinorelbine Plus Cisplatin in Neoadjuvant Chemoradiotherapy for Esophageal Cancer (NEOCRTEC308)
A Phase 3 study testing Docetaxel, Cisplatin and Radiation in people with Esophageal Squamous Cell Carcinoma and Esophageal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The primary objective is to compare docetaxel plus cisplatin (DP) versus vinorelbine plus cisplatin (NP) in neoadjuvant chemoradiotherapy, in terms of the overall survival and toxicity in patients with Stage IIB or III squamous cell esophageal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Esophageal Cancer, Oesophageal Cancer
- What is being tested?
- Docetaxel, Cisplatin and Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Jul 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T4aN0M0, according to 7th edition of Union for International Cancer Control (UICC) staging system.
- Patients must not have received any prior anticancer therapy.
- More than 6 months of expected survival
- Age ranges from 18 to 70 years
- Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
- WHO performance status (PS) of 0-1
- Signed informed consent document on file
Who cannot join
- Patients have received any prior anticancer therapy
- Patients with advanced inoperable or metastatic esophageal carcinoma
- Patients with concomitant hemorrhagic disease
- Patients with other uncontrollable status that cannot tolerate surgery
- Pregnant or breast feeding
- Patients cannot signed the informed consent document because of psychological quality, family and social factors
Show all 10Show fewer
- Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more
- Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer
- Have a history of diabetes over 10 years and with poorly controlled blood sugar level
- patients with serious cardiac, respiratory, hepatic, renal, hematologic, immunological disease or cachexy, who cannot tolerate chemoradiotherapy or surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Clinical Trial of Docetaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin in Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC308)
The primary objective is to compare docetaxel plus cisplatin (DP) versus vinorelbine plus cisplatin (NP) in neoadjuvant chemoradiotherapy, in terms of the overall survival and toxicity in patients with Stage IIB or III squamous cell esophageal carcinoma.
Read the detailed description
Esophageal cancer (EC) is the eighth most common cancers in the world, with more than 456,000 new cases and 400,000 deaths occurred annually worldwide. Every year in China, no matter new cases or deaths account for more than half of the world. Besides, over 90% of Chinese patients have esophageal squamous cell carcinoma (ESCC).
Preoperative chemoradiotherapy (CRT) followed by surgery can hopefully improve the survival of ESCC. The CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increase the overall survival of patients with EC compared with surgery alone. The therapeutic effects were also found in 84 ESCC cases enrolled in this trial. Previously, the investigators performed a phase III, randomized clinical trial (NCT01216527) to compare the overall survival of stage IIB-III ESCC patients treated with or without neoadjuvant CRT, in which vinorelbine plus cisplatin was used as chemotherapy regime. The enrollment was completed in 2014. The outcomes will hopefully prove the survival benefit of neoadjuvant CRT to ESCC.
However, the investigators also observed that some patients suffer from the toxic response of neoadjuvant therapy, such as myelosuppression (45.2%), pulmonary toxicity (42.9%), and esophagitis (59.5%). The toxicity caused by CRT will decrease the patient compliance; moreover increase the perioperative complications and deaths, which may totally offset the survival benefit. Therefore, it is important to improve chemoradiotherapy effect and reduce toxicity, so as to achieve better survival in ESCC patients.
Docetaxel draws increasing attentions with its high effective rate and low toxicity. Several Phase II clinical trials and retrospective studies suggested that docetaxel showed better survival benefits in both monotherapy and combined-therapy in EC patients. Therefore, the investigators intended to conduct a phase III, randomized clinical trial to further explore whether docetaxel plus cisplatin would be an effective therapy with lower toxicity.
The investigators are to carry out a phased III clinical trial to compare the effect and toxicity of docetaxel plus cisplatin with vinorelbine plus cisplatin in neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma.
- Being tested
- Docetaxel, Cisplatin, Radiation, Surgery, Vinorelbine
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Docetaxel in Arm A
25mg/ m2 Docetaxel dose administered on days 1, 8, 15, and 22.
CisplatinDrug
Also called Cisplatin in Arm A
25mg/ m2 on days 1, 8, 15 and 22.
RadiationRadiation
Also called IMRT
Patient will receive 4 weeks of radiation therapy (44 Gy/20 fractions).
SurgeryProcedure or surgery
Also called Esophagectomy
McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 4-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.
VinorelbineDrug
Also called Vinorelbine in Arm B
25mg/ m2 on days 1, 8 of each cycle (i.e. every 21 days).
CisplatinDrug
Also called Cisplatin in Arm B
75mg/ m2 on day 1 of each cycle only (i.e. every 21 days).
| Study group | Role | What they receive |
|---|---|---|
| A (DP-RT) | Experimental | • Arm A consists of the concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy and 4 weekly cycles of chemotherapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22.
Interventions:
* Radiation: (44 Gy/20 fractions)
* Drug: Docetaxel
* Drug: Cisplatin Receives: Drug: Docetaxel; Drug: Cisplatin; Radiation: Radiation; Procedure: Surgery |
| B (NP-RT) | Experimental | • Arm B consists of the concurrent chemoradiotherapy followed by surgery. The patient will receive 4 weeks of radiation therapy and 2 cycles of chemotherapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Each cycle of chemotherapy lasts 21 days/3 weeks. The drugs include Vinorelbine and Cisplatin.
Interventions:
* Radiation: (44 Gy/20 fractions)
* Drug: Vinorelbine
* Drug: Cisplatin Receives: Radiation: Radiation; Procedure: Surgery; Drug: Vinorelbine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival will be calculated from the date of randomisation and an event registered on the date of death from any cause. Patients lost to follow up, or those with no death recorded on the day the database is frozen, will be censored on the date of last follow up.
Measured: At end of trial- up to 3 years in follow up
Toxicities of neo-adjuvant chemoradiotherapy
All symptoms of toxicity will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) Version. 3.0.
Measured: Within the first 56 days after the start of chemoradiotherapy
Secondary outcomes (7)
Disease free survival
Measured: At end of trial- up to 3 years in follow up
Clinical response rate
Measured: 4-6 weeks after completion of chemoradiotherapy
R0 resection rate
Measured: One week after the operation
Number of Participants who withdraw the treatment
Measured: Within the first 84 days after the start of chemoradiotherapy
Perioperative complication
Measured: Within the first 90 days after the start of surgery
Pathological complete response rate
Measured: One week after the operation
Health Related Quality of Life
Measured: Within the first 84 days after the start of chemoradiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Hong, Sun Yat-sen University
- Investigators
- Hong Yang, Ph.D., M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465736
- Sponsor's protocol ID
- NEOCRTEC-2.0
- Status last verified
- Jan 2024
- First submitted
- 30 May 2015
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wang J, Wei C, Tucker SL, Myles B, Palmer M, Hofstetter WL, Swisher SG, Ajani JA, Cox JD, Komaki R, Liao Z, Lin SH. Predictors of postoperative complications after trimodality therapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2013 Aug 1;86(5):885-91. doi: 10.1016/j.ijrobp.2013.04.006.
PubMed 23845841Bhansali MS, Vaidya JS, Bhatt RG, Patil PK, Badwe RA, Desai PB. Chemotherapy for carcinoma of the esophagus: a comparison of evidence from meta-analyses of randomized trials and of historical control studies. Ann Oncol. 1996 Apr;7(4):355-9. doi: 10.1093/oxfordjournals.annonc.a010601.
PubMed 8805926Arnott SJ, Duncan W, Gignoux M, Hansen HS, Launois B, Nygaard K, Parmar MK, Rousell A, Spilopoulos G, Stewart G, Tierney JF, Wang M, Rhugang Z; Oeosphageal Cancer Collaborative Group. Preoperative radiotherapy for esophageal carcinoma. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD001799. doi: 10.1002/14651858.CD001799.pub2.
PubMed 16235286Sjoquist KM, Burmeister BH, Smithers BM, Zalcberg JR, Simes RJ, Barbour A, Gebski V; Australasian Gastro-Intestinal Trials Group. Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol. 2011 Jul;12(7):681-92. doi: 10.1016/S1470-2045(11)70142-5. Epub 2011 Jun 16.
PubMed 21684205Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30.
PubMed 24982463Kushida T, Nohara S, Yoshino K, Fujiwara D, Ouchi K, Amano T, Isayama F, Tomita N, Iwanuma Y, Sasai K, Tsurumaru M, Kajiyama Y. Utility of weekly docetaxel combined with preoperative radiotherapy for locally advanced esophageal cancer from pathological analysis. Dis Esophagus. 2014 May-Jun;27(4):368-73. doi: 10.1111/dote.12105. Epub 2013 Jul 19.
PubMed 23865505Zanoni A, Verlato G, Giacopuzzi S, Weindelmayer J, Casella F, Pasini F, Zhao E, de Manzoni G. Neoadjuvant concurrent chemoradiotherapy for locally advanced esophageal cancer in a single high-volume center. Ann Surg Oncol. 2013 Jun;20(6):1993-9. doi: 10.1245/s10434-012-2822-4. Epub 2012 Dec 29.
PubMed 23274533Pasini F, de Manzoni G, Zanoni A, Grandinetti A, Capirci C, Pavarana M, Tomezzoli A, Rubello D, Cordiano C. Neoadjuvant therapy with weekly docetaxel and cisplatin, 5-fluorouracil continuous infusion, and concurrent radiotherapy in patients with locally advanced esophageal cancer produced a high percentage of long-lasting pathological complete response: a phase 2 study. Cancer. 2013 Mar 1;119(5):939-45. doi: 10.1002/cncr.27822. Epub 2012 Nov 16.
PubMed 23165781Ruhstaller T, Widmer L, Schuller JC, Roth A, Hess V, Mingrone W, von Moos R, Borner M, Pestalozzi BC, BalmerMajno S, Koberle D, Terraciano L, Schnider A, Bodis S, Popescu R; Swiss Group for Clinical Cancer Research (SAKK). Multicenter phase II trial of preoperative induction chemotherapy followed by chemoradiation with docetaxel and cisplatin for locally advanced esophageal carcinoma (SAKK 75/02). Ann Oncol. 2009 Sep;20(9):1522-1528. doi: 10.1093/annonc/mdp045. Epub 2009 May 22.
PubMed 19465425Lin SH, Wang L, Myles B, Thall PF, Hofstetter WL, Swisher SG, Ajani JA, Cox JD, Komaki R, Liao Z. Propensity score-based comparison of long-term outcomes with 3-dimensional conformal radiotherapy vs intensity-modulated radiotherapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2012 Dec 1;84(5):1078-85. doi: 10.1016/j.ijrobp.2012.02.015. Epub 2012 Aug 3.
PubMed 22867894
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Trial of Docetaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin in Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC308)
- ClinicalTrials.gov ID
- NCT02465736
- Acronym / sponsor ID
- NEOCRTEC-2.0
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 8 Jun 2015 (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 primary objective is to compare docetaxel plus cisplatin (DP) versus vinorelbine plus cisplatin (NP) in neoadjuvant chemoradiotherapy, in terms of the overall survival and toxicity in patients with Stage IIB or III squamous cell esophageal carcinoma.
Detailed description
Esophageal cancer (EC) is the eighth most common cancers in the world, with more than 456,000 new cases and 400,000 deaths occurred annually worldwide. Every year in China, no matter new cases or deaths account for more than half of the world. Besides, over 90% of Chinese patients have esophageal squamous cell carcinoma (ESCC).
Preoperative chemoradiotherapy (CRT) followed by surgery can hopefully improve the survival of ESCC. The CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increase the overall survival of patients with EC compared with surgery alone. The therapeutic effects were also found in 84 ESCC cases enrolled in this trial. Previously, the investigators performed a phase III, randomized clinical trial (NCT01216527) to compare the overall survival of stage IIB-III ESCC patients treated with or without neoadjuvant CRT, in which vinorelbine plus cisplatin was used as chemotherapy regime. The enrollment was completed in 2014. The outcomes will hopefully prove the survival benefit of neoadjuvant CRT to ESCC.
However, the investigators also observed that some patients suffer from the toxic response of neoadjuvant therapy, such as myelosuppression (45.2%), pulmonary toxicity (42.9%), and esophagitis (59.5%). The toxicity caused by CRT will decrease the patient compliance; moreover increase the perioperative complications and deaths, which may totally offset the survival benefit. Therefore, it is important to improve chemoradiotherapy effect and reduce toxicity, so as to achieve better survival in ESCC patients.
Docetaxel draws increasing attentions with its high effective rate and low toxicity. Several Phase II clinical trials and retrospective studies suggested that docetaxel showed better survival benefits in both monotherapy and combined-therapy in EC patients. Therefore, the investigators intended to conduct a phase III, randomized clinical trial to further explore whether docetaxel plus cisplatin would be an effective therapy with lower toxicity.
The investigators are to carry out a phased III clinical trial to compare the effect and toxicity of docetaxel plus cisplatin with vinorelbine plus cisplatin in neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (DP-RT) | Experimental | Drug: Docetaxel, Drug: Cisplatin, Radiation: Radiation, Procedure: Surgery• Arm A consists of the concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy and 4 weekly cycles of chemotherapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22. Interventions: * Radiation: (44 Gy/20 fractions) * Drug: Docetaxel * Drug: Cisplatin |
| B (NP-RT) | Experimental | Radiation: Radiation, Procedure: Surgery, Drug: Vinorelbine, Drug: Cisplatin• Arm B consists of the concurrent chemoradiotherapy followed by surgery. The patient will receive 4 weeks of radiation therapy and 2 cycles of chemotherapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Each cycle of chemotherapy lasts 21 days/3 weeks. The drugs include Vinorelbine and Cisplatin. Interventions: * Radiation: (44 Gy/20 fractions) * Drug: Vinorelbine * Drug: Cisplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T4aN0M0, according to 7th edition of Union for International Cancer Control (UICC) staging system.
- Patients must not have received any prior anticancer therapy.
- More than 6 months of expected survival
- Age ranges from 18 to 70 years
- Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
Key exclusion criteria (10 listed)
- Patients have received any prior anticancer therapy
- Patients with advanced inoperable or metastatic esophageal carcinoma
- Patients with concomitant hemorrhagic disease
- Patients with other uncontrollable status that cannot tolerate surgery
- Pregnant or breast feeding
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 |
|---|---|---|
| DocetaxelAlso: Docetaxel in Arm A25mg/ m2 Docetaxel dose administered on days 1, 8, 15, and 22. | Drug | A (DP-RT) |
| CisplatinAlso: Cisplatin in Arm A25mg/ m2 on days 1, 8, 15 and 22. | Drug | A (DP-RT) |
| RadiationAlso: IMRTPatient will receive 4 weeks of radiation therapy (44 Gy/20 fractions). | Radiation | A (DP-RT), B (NP-RT) |
| SurgeryAlso: EsophagectomyMcKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 4-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery. | Procedure or surgery | A (DP-RT), B (NP-RT) |
| VinorelbineAlso: Vinorelbine in Arm B25mg/ m2 on days 1, 8 of each cycle (i.e. every 21 days). | Drug | B (NP-RT) |
| CisplatinAlso: Cisplatin in Arm B75mg/ m2 on day 1 of each cycle only (i.e. every 21 days). | Drug | B (NP-RT) |
Primary outcome
Overall survival
Time frame: At end of trial- up to 3 years in follow up
Overall survival will be calculated from the date of randomisation and an event registered on the date of death from any cause. Patients lost to follow up, or those with no death recorded on the day the database is frozen, will be censored on the date of last follow up.
Toxicities of neo-adjuvant chemoradiotherapy
Time frame: Within the first 56 days after the start of chemoradiotherapy
All symptoms of toxicity will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) Version. 3.0.
7 secondary outcomes
Disease free survival
Time frame: At end of trial- up to 3 years in follow up
Clinical response rate
Time frame: 4-6 weeks after completion of chemoradiotherapy
R0 resection rate
Time frame: One week after the operation
Number of Participants who withdraw the treatment
Time frame: Within the first 84 days after the start of chemoradiotherapy
Perioperative complication
Time frame: Within the first 90 days after the start of surgery
Pathological complete response rate
Time frame: One week after the operation
Health Related Quality of Life
Time frame: Within the first 84 days after the start of chemoradiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Background: PubMed 23845841Wang J, Wei C, Tucker SL, Myles B, Palmer M, Hofstetter WL, Swisher SG, Ajani JA, Cox JD, Komaki R, Liao Z, Lin SH. Predictors of postoperative complications after trimodality therapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2013 Aug 1;86(5):885-91. doi: 10.1016/j.ijrobp.2013.04.006.
- Results publication: PubMed 8805926Bhansali MS, Vaidya JS, Bhatt RG, Patil PK, Badwe RA, Desai PB. Chemotherapy for carcinoma of the esophagus: a comparison of evidence from meta-analyses of randomized trials and of historical control studies. Ann Oncol. 1996 Apr;7(4):355-9. doi: 10.1093/oxfordjournals.annonc.a010601.
- Results publication: PubMed 16235286Arnott SJ, Duncan W, Gignoux M, Hansen HS, Launois B, Nygaard K, Parmar MK, Rousell A, Spilopoulos G, Stewart G, Tierney JF, Wang M, Rhugang Z; Oeosphageal Cancer Collaborative Group. Preoperative radiotherapy for esophageal carcinoma. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD001799. doi: 10.1002/14651858.CD001799.pub2.
- Results publication: PubMed 21684205Sjoquist KM, Burmeister BH, Smithers BM, Zalcberg JR, Simes RJ, Barbour A, Gebski V; Australasian Gastro-Intestinal Trials Group. Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol. 2011 Jul;12(7):681-92. doi: 10.1016/S1470-2045(11)70142-5. Epub 2011 Jun 16.
- Results publication: PubMed 24982463Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30.
- Results publication: PubMed 23865505Kushida T, Nohara S, Yoshino K, Fujiwara D, Ouchi K, Amano T, Isayama F, Tomita N, Iwanuma Y, Sasai K, Tsurumaru M, Kajiyama Y. Utility of weekly docetaxel combined with preoperative radiotherapy for locally advanced esophageal cancer from pathological analysis. Dis Esophagus. 2014 May-Jun;27(4):368-73. doi: 10.1111/dote.12105. Epub 2013 Jul 19.
- Results publication: PubMed 23274533Zanoni A, Verlato G, Giacopuzzi S, Weindelmayer J, Casella F, Pasini F, Zhao E, de Manzoni G. Neoadjuvant concurrent chemoradiotherapy for locally advanced esophageal cancer in a single high-volume center. Ann Surg Oncol. 2013 Jun;20(6):1993-9. doi: 10.1245/s10434-012-2822-4. Epub 2012 Dec 29.
- Results publication: PubMed 23165781Pasini F, de Manzoni G, Zanoni A, Grandinetti A, Capirci C, Pavarana M, Tomezzoli A, Rubello D, Cordiano C. Neoadjuvant therapy with weekly docetaxel and cisplatin, 5-fluorouracil continuous infusion, and concurrent radiotherapy in patients with locally advanced esophageal cancer produced a high percentage of long-lasting pathological complete response: a phase 2 study. Cancer. 2013 Mar 1;119(5):939-45. doi: 10.1002/cncr.27822. Epub 2012 Nov 16.
- Results publication: PubMed 19465425Ruhstaller T, Widmer L, Schuller JC, Roth A, Hess V, Mingrone W, von Moos R, Borner M, Pestalozzi BC, BalmerMajno S, Koberle D, Terraciano L, Schnider A, Bodis S, Popescu R; Swiss Group for Clinical Cancer Research (SAKK). Multicenter phase II trial of preoperative induction chemotherapy followed by chemoradiation with docetaxel and cisplatin for locally advanced esophageal carcinoma (SAKK 75/02). Ann Oncol. 2009 Sep;20(9):1522-1528. doi: 10.1093/annonc/mdp045. Epub 2009 May 22.
- Results publication: PubMed 22867894Lin SH, Wang L, Myles B, Thall PF, Hofstetter WL, Swisher SG, Ajani JA, Cox JD, Komaki R, Liao Z. Propensity score-based comparison of long-term outcomes with 3-dimensional conformal radiotherapy vs intensity-modulated radiotherapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2012 Dec 1;84(5):1078-85. doi: 10.1016/j.ijrobp.2012.02.015. Epub 2012 Aug 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Yang, Ph.D., M.D. principal investigator
Sun Yat-sen University
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 Docetaxel, Cisplatin and Radiation in people with Esophageal Squamous Cell Carcinoma and Esophageal Cancer, run by Sun Yat-sen 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 7 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: status not confirmed, as of the sponsor's last update on 16 Jan 2024. 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 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?
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?
Overall survival (time frame: At end of trial- up to 3 years in follow up). The study lists 2 primary outcomes in all. 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 NCT02465736, which also lists 10 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 16 Jan 2024.