Study of Docetaxel or Vinorelbine Plus Cisplatin in Neoadjuvant Chemoradiotherapy for Esophageal Cancer (NEOCRTEC308)

NCT02465736 | Unknown Phase 3 DMC

• 1 other identifier: NEOCRTEC-2.0
• Study Type: interventional
• Target: 610
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Cancer; Oesophageal Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Within the first 56 days after the start of chemoradiotherapy

Secondary Outcomes (7)

• Disease free survival

  At end of trial- up to 3 years in follow up

• Clinical response rate

  4-6 weeks after completion of chemoradiotherapy

• R0 resection rate

  One week after the operation

• Number of Participants who withdraw the treatment

  Within the first 84 days after the start of chemoradiotherapy

• Perioperative complication

  Within the first 90 days after the start of surgery

Study Arms (2)

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

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

Radiation: Radiation; Procedure: Surgery; Drug: Vinorelbine; Drug: Cisplatin

Interventions

Docetaxel DRUG

25mg/ m2 Docetaxel dose administered on days 1, 8, 15, and 22.

Also known as: Docetaxel in Arm A

A (DP-RT)

Radiation RADIATION

Patient will receive 4 weeks of radiation therapy (44 Gy/20 fractions).

Also known as: IMRT

A (DP-RT); B (NP-RT)

Surgery PROCEDURE

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.

Also known as: Esophagectomy

A (DP-RT); B (NP-RT)

Vinorelbine DRUG

25mg/ m2 on days 1, 8 of each cycle (i.e. every 21 days).

Also known as: Vinorelbine in Arm B

B (NP-RT)

Cisplatin DRUG

25mg/ m2 on days 1, 8, 15 and 22.

Also known as: Cisplatin in Arm A

A (DP-RT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (10)

• 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.

  PMID: 23845841 BACKGROUND

• Bhansali 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.

  PMID: 8805926 RESULT

• Arnott 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.

  PMID: 16235286 RESULT

• Sjoquist 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.

  PMID: 21684205 RESULT

• Mariette 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.

  PMID: 24982463 RESULT

• Kushida 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.

  PMID: 23865505 RESULT

• Zanoni 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.

  PMID: 23274533 RESULT

• Pasini 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.

  PMID: 23165781 RESULT

• Ruhstaller 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.

  PMID: 19465425 RESULT

• Lin 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.

  PMID: 22867894 RESULT

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms

Interventions

Docetaxel; Cisplatin; Radiation; Surgical Procedures, Operative; Esophagectomy; Vinorelbine

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena; Digestive System Surgical Procedures; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Hong Yang, Ph.D., M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 30, 2015
• First Posted: June 8, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)