Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma

NCT02446574 | Completed Phase 1 DMC

• 1 other identifier: 02-27/230
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a unicentered phase I/II study to explore the dose of paclitaxel and cisplatin with radiation therapy, and to document the adverse events for further clinical trial.

Conditions

Esophageal Neoplasms

Keywords

chemoradiation; dose escalation

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of weekly paclitaxel and cisplatin with concurrent radiation(Phase I endpoint)

  3 months

Secondary Outcomes (3)

• Toxicities according to the Common Terminology Criteria for Adverse Events version 3.0.

  18 months

• Overall Survival survival of weekly paclitaxel and cisplatin with concurrent radiation(Phase II endpoint)

  60 months

• Disease-free survival of weekly paclitaxel and cisplatin with concurrent radiation(Phase II endpoint)

  36 months

Study Arms (1)

Arm A

EXPERIMENTAL

During the Phase I it will administered weekly paclitaxel(dose escalation) and cisplatin with concurrent radiation therapy During the Phase II it will administered weekly paclitaxel(dose according to phase I) and cisplatin with concurrent radiation therapy

Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiation

Interventions

Paclitaxel DRUG

starting dose 20mg/m2 qw

Also known as: taxel

Arm A

Cisplatin DRUG

dose 25mg/m2 qw

Also known as: platimum

Arm A

Radiation RADIATION

60Gy/2Gy/30f

Arm A

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• KPS≥70
• Diagnosis of pathologically positive lymph node thoracic esophageal cancer
• Complete resection
• Adequate organ function:
• Hematopoietic Absolute granulocyte count at least 1,500/mm\^3 Platelet count at least 150,000/mm\^3 Hemoglobin at least 10 g/dL Hepatic Not specified Renal Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance at least 65 mL/min Calcium no greater than 11 mg/dL Cardiovascular No uncontrolled heart disease No uncontrolled hypertension

You may not qualify if:

• Uncontrolled diabetes
• Interval between surgery and adjuvant therapy more than 3 months
• Sign of recurrence on CT scan or ultrasound or PET-CT No palpable supraclavicular lymph nodes or involvement after cytology needle aspiration No lymph nodes greater than 1 cm on CT scan
• With Weight loss greater than 10% from baseline
• With other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
• Be pregnant

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (11)

• Rizk N, Venkatraman E, Park B, Flores R, Bains MS, Rusch V; American Joint Committee on Cancer staging system. The prognostic importance of the number of involved lymph nodes in esophageal cancer: implications for revisions of the American Joint Committee on Cancer staging system. J Thorac Cardiovasc Surg. 2006 Dec;132(6):1374-81. doi: 10.1016/j.jtcvs.2006.07.039.

  PMID: 17140960 RESULT

• Korst RJ, Rusch VW, Venkatraman E, Bains MS, Burt ME, Downey RJ, Ginsberg RJ. Proposed revision of the staging classification for esophageal cancer. J Thorac Cardiovasc Surg. 1998 Mar;115(3):660-69; discussion 669-70. doi: 10.1016/S0022-5223(98)70332-0.

  PMID: 9535455 RESULT

• Rice TW, Blackstone EH, Rybicki LA, Adelstein DJ, Murthy SC, DeCamp MM, Goldblum JR. Refining esophageal cancer staging. J Thorac Cardiovasc Surg. 2003 May;125(5):1103-13. doi: 10.1067/mtc.2003.170.

  PMID: 12771884 RESULT

• Hagen JA, DeMeester SR, Peters JH, Chandrasoma P, DeMeester TR. Curative resection for esophageal adenocarcinoma: analysis of 100 en bloc esophagectomies. Ann Surg. 2001 Oct;234(4):520-30; discussion 530-1. doi: 10.1097/00000658-200110000-00011.

  PMID: 11573045 RESULT

• Igaki H, Kato H, Tachimori Y, Nakanishi Y. Prognostic evaluation of patients with clinical T1 and T2 squamous cell carcinomas of the thoracic esophagus after 3-field lymph node dissection. Surgery. 2003 Apr;133(4):368-74. doi: 10.1067/msy.2003.76.

  PMID: 12717353 RESULT

• 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: 22646630 RESULT

• Rice TW, Adelstein DJ, Chidel MA, Rybicki LA, DeCamp MM, Murthy SC, Blackstone EH. Benefit of postoperative adjuvant chemoradiotherapy in locoregionally advanced esophageal carcinoma. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1590-6. doi: 10.1016/s0022-5223(03)01025-0.

  PMID: 14666038 RESULT

• Liu HC, Hung SK, Huang CJ, Chen CC, Chen MJ, Chang CC, Tai CJ, Tzen CY, Lu LH, Chen YJ. Esophagectomy for locally advanced esophageal cancer, followed by chemoradiotherapy and adjuvant chemotherapy. World J Gastroenterol. 2005 Sep 14;11(34):5367-72. doi: 10.3748/wjg.v11.i34.5367.

  PMID: 16149148 RESULT

• Hsu PK, Huang CS, Wang BY, Wu YC, Hsu WH. Survival benefits of postoperative chemoradiation for lymph node-positive esophageal squamous cell carcinoma. Ann Thorac Surg. 2014 May;97(5):1734-41. doi: 10.1016/j.athoracsur.2013.12.041. Epub 2014 Mar 6.

  PMID: 24612702 RESULT

• Chen J, Pan J, Liu J, Li J, Zhu K, Zheng X, Chen M, Chen M, Liao Z. Postoperative radiation therapy with or without concurrent chemotherapy for node-positive thoracic esophageal squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2013 Jul 15;86(4):671-7. doi: 10.1016/j.ijrobp.2013.03.026.

  PMID: 23773390 RESULT

• Xiao ZF, Yang ZY, Liang J, Miao YJ, Wang M, Yin WB, Gu XZ, Zhang DC, Zhang RG, Wang LJ. Value of radiotherapy after radical surgery for esophageal carcinoma: a report of 495 patients. Ann Thorac Surg. 2003 Feb;75(2):331-6. doi: 10.1016/s0003-4975(02)04401-6.

  PMID: 12607634 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Paclitaxel; Cisplatin; Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; 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

Study Officials

• Zefen Xiao, Professor

  Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 26, 2015
• First Posted: May 18, 2015
• Study Start: July 1, 2007
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

CN (1)