NCT02938195

Brief Summary

The investigators designed a new preoperative chemoradiotherapy regimen to focus on the most important radiation area and hope to reduce the radiation volume and try to reduce the postoperative mortality and treatment-related mortality.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

October 15, 2016

Last Update Submit

October 18, 2016

Conditions

Esophageal CancerChemoradiationSurgery

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients completing adjuvant chemoradiotherapy and surgery

    4-8weeks after surgery

Secondary Outcomes (2)

  • Percentage of R0 resection

    4-8weeks after surgery

  • Percentage of pathological complete response

    4-8weeks after surgery

Study Arms (1)

experimental arm

EXPERIMENTAL

PF regimen (cis-platinum of 25 mg/m2/d, d1-3; 5-fluorouracil of 500mg/m2/d, d1-4) every 4 weeks for 2 cycles concurrently with three-dimensional radiation therapy or intensity-modulated radiotherapy followed by surgery 4-8weeks after neoadjuvant therapy in a standard manner.

Radiation: radiotherapyProcedure: Surgery

Interventions

radiotherapyRADIATION

The clinical target volume of radiotherapy only includes the visible tumor and lymph nodes and the investigators wouldn't do any prophylactic radiation treatment.

experimental arm
SurgeryPROCEDURE

Surgery would be done 4-8 weeks after neoadjuvant chemoradiotherapy.

experimental arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or III, which is potentially resectable.
  • 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.
  • Karnofsky performance status (KPS) of 90 or more.
  • Signed informed consent document on file.

You may not qualify if:

  • Patients are diagnosed or suspected to be allergic to cisplatin or 5-Fu.
  • Patients with concomitant hemorrhagic disease.
  • Pregnant or breast feeding.
  • Inability to use gastric conduit after esophagectomy because of a prior surgery.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (7)

  • Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5.

    PMID: 26254683BACKGROUND

  • van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.

    PMID: 22646630BACKGROUND

  • Huang TC, Hsu CH, Lin CC, Tu YK. Systematic review and network meta-analysis: neoadjuvant chemoradiotherapy for locoregional esophageal cancer. Jpn J Clin Oncol. 2015 Nov;45(11):1023-8. doi: 10.1093/jjco/hyv119. Epub 2015 Aug 5.

    PMID: 26246479BACKGROUND

  • Martinek J, Akiyama JI, Vackova Z, Furnari M, Savarino E, Weijs TJ, Valitova E, van der Horst S, Ruurda JP, Goense L, Triadafilopoulos G. Current treatment options for esophageal diseases. Ann N Y Acad Sci. 2016 Oct;1381(1):139-151. doi: 10.1111/nyas.13146. Epub 2016 Jul 8.

    PMID: 27391867BACKGROUND

  • Ikebe M, Morita M, Yamamoto M, Toh Y. Neoadjuvant therapy for advanced esophageal cancer: the impact on surgical management. Gen Thorac Cardiovasc Surg. 2016 Jul;64(7):386-94. doi: 10.1007/s11748-016-0655-y. Epub 2016 May 10.

    PMID: 27165288BACKGROUND

  • Purwar P, Bambarkar S, Jiwnani S, Karimundackal G, Laskar SG, Pramesh CS. Multimodality management of esophageal cancer. Indian J Surg. 2014 Dec;76(6):494-503. doi: 10.1007/s12262-014-1163-x. Epub 2014 Sep 11.

    PMID: 25614726BACKGROUND

  • Kumagai K, Rouvelas I, Tsai JA, Mariosa D, Klevebro F, Lindblad M, Ye W, Lundell L, Nilsson M. Meta-analysis of postoperative morbidity and perioperative mortality in patients receiving neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal and gastro-oesophageal junctional cancers. Br J Surg. 2014 Mar;101(4):321-38. doi: 10.1002/bjs.9418. Epub 2014 Feb 3.

    PMID: 24493117BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

RadiotherapySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Xiaolong Fu, Ph.D

    Department of Radiation Oncology,Shanghai Chest Hospital

    STUDY DIRECTOR

Central Study Contacts

Jun Liu, Doctor

CONTACT

+862122200000drjunliu@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

October 15, 2016

First Posted

October 19, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

October 19, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)