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AzTrials

Esophageal NeoplasmsPhase 1/2NCT02446574

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

A Phase 1/2 study testing Paclitaxel, Cisplatin and Radiation in people with Esophageal Neoplasms, run by Chinese Academy of Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 68 years
Conditions the study is for
Esophageal Neoplasms
What is being tested?
Paclitaxel, Cisplatin and Radiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
Jul 2007to Dec 2016
Phase
Phase 1/2
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 68 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Institute and Hospital, Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: Phase I /II Study of Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma

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.

Read the detailed description

Although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, the considerable number of esophageal cancer patients received operation as the first treatment modality. Accordingly, postoperative treatments have been playing an important role because of the poor survival rates of the patients with pathologically positive lymph nodes who have been treated with resection alone. The investigators have proved the value of prophylactic radiation therapy after radical esophagectomy for esophageal carcinoma with positive lymph node metastases under the conventional 2-dimensional radiotherapy methods in subset analysis of prospective randomized clinical trial. For patients with positive lymph nodes, 5 year survival after surgery alone was 28.4%, median overall survival was 24 months, recurrence occurred 34.6% in mediastinal lymph nodes，13.3% in supraclavicular lymph nodes，10% in abdominal lymph nodes. Distant metastases occurred in 21% patients. Adjuvant radiotherapy significantly reduced the recurrence in mediastinal lymph nodes(13.4%), supraclavicular lymph nodes (6.1%). However distant metastases rate increased to 30.7%. Chemotherapy may be vital for these patients. Chen reported that the 5 year overall survival rates for the chemoradiotherapy group and radiotherapy group were 47.4% and 38.6% (P=0.03). Based on the investigators' studies, treatment failure occurred in 8% patients because of celiac metastases. Small radiation field by omitting celiac axis lymph node basin may ensure 5-6 cycles of concurrent chemotherapy for lower toxicity.

Keywords
chemoradiation, dose escalation
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02446574
Study groupRoleWhat they receive
Arm AExperimentalDuring 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
Receives: Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months

Secondary outcomes (3)

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

    Measured: 18 months

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

    Measured: 60 months

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

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2015 (estimated)
  2. Study startJul 2007
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02446574
Sponsor's protocol ID
02-27/230
Status last verified
Oct 2017
First submitted
26 Apr 2015
Last updated
24 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17140960

  • 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.

    PubMed 9535455

  • 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.

    PubMed 12771884

  • 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.

    PubMed 11573045

  • 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.

    PubMed 12717353

  • 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.

    PubMed 22646630

  • 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.

    PubMed 14666038

  • 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.

    PubMed 16149148

  • 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.

    PubMed 24612702

  • 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.

    PubMed 23773390

  • 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.

    PubMed 12607634

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Paclitaxel, Cisplatin and Radiation in people with Esophageal Neoplasms, run by Chinese Academy of Medical Sciences 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 24 Oct 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum tolerated dose of weekly paclitaxel and cisplatin with concurrent radiation(Phase I endpoint) (time frame: 3 months). 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 NCT02446574, which also lists 11 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 24 Oct 2017.

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