NCT03006575

Brief Summary

This Phase II randomized study is to determine the efficacy of split-course irradiation with concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after surgical resection

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
57

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

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

August 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

4.8 years

First QC Date

April 13, 2016

Last Update Submit

January 15, 2021

Conditions

Keywords

Non-small cell lung cancerSplit-course ChemoradiotherapyLocoregional recurrencePostoperative recurrence

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    2 years

Secondary Outcomes (4)

  • Overall Survival

    2 years

  • Response Rate

    2 years

  • rate of patients who develop local recurrence or distant recurrence

    2 year

  • rate of grade 3-4 radiation pneumonitis/esophagitis evaluated by Common Terminology Criteria for Adverse Events Version 4.0

    1 year

Study Arms (1)

split-course radiotherapy

EXPERIMENTAL

The radiotherapy is delivered using simultaneous integrated boost (SIB)-IMRT. Patients are irradiation at a palliative dose at the initial course: 40-51Gy/10-17f to PTV-GTV. The disease is re-evaluated one month after the end of the initial course using CT. The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost. At the second course, the tumor is repositioned and scanned. The residual tumor was then treated with the second course of radiotherapy. A dose of 15-24 Gy/5-8f is delivered to the residue tumor. Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.

Radiation: split-course radiotherapyDrug: concurrent chemotherapy

Interventions

split-course chest radiation at 40-51 Gy/10-17f and 15-24 Gy/5-8f

split-course radiotherapy

weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation

split-course radiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologic confirmation of NSCLC.
  • Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • Postoperative locoregional recurrence including ipsilateral hemithorax and the mediastinum.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Previously treated with chemotherapy or treatment-naive
  • No previous chest radiotherapy, immunotherapy or biotherapy
  • Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
  • Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
  • Bilirubin ≤1.5 times UNL, AST(SGOT)≤2.5 times UNL ,ALT(SGPT)≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
  • Forced expiratory volume at one second (FEV1) \>0.8 L
  • Coagulation tests within normal limits
  • patients and their family signed the informed consents

You may not qualify if:

  • Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ
  • Second primary carcinoma of the lung
  • Contraindication for chemotherapy
  • Malignant pleural or pericardial effusion.
  • Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dos
  • Women who has the probability of pregnancy without contraception
  • Tendency of hemorrhage
  • In other clinical trials within 30 days
  • Addicted in drugs or alcohol, AIDS patients
  • Uncontrollable seizure or psychotic patients without self-control ability
  • Severe allergy or idiosyncrasy
  • Not suitable for this study judged by researchers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hui Liu

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (46)

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hui Liu, professor

    Sun yat-sen universtiy cancer center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Qiu, attending

CONTACT

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
Professor

Study Record Dates

First Submitted

April 13, 2016

First Posted

December 30, 2016

Study Start

August 1, 2015

Primary Completion

June 1, 2020

Study Completion

July 1, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations