NCT03598517

Brief Summary

To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced non-small lung cancer.

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 not_applicable nonsmall-cell-lung-cancer

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable 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

July 1, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

2.8 years

First QC Date

July 15, 2018

Last Update Submit

August 21, 2020

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • overall survival rate

    survival time was measured from the date of study enrollment to the date of death or last follow-up

    2 year

Secondary Outcomes (1)

  • toxicities

    2 year

Study Arms (1)

high dose chemoradiotherapy

EXPERIMENTAL

all eligible patients receive image-guided intensity-modulated radiotherapy 60 Gy in 30 fractions over 6 weeks and concurrent weekly paclitaxel and cisplatin，followed by hyperfractionated intensity-modulated radiotherapy boost to residual metabolic disease concurrent with the same chemotherapy regimen, followed by adjuvant chemotherapy 6 weeks after completion of radiation therapy.

Radiation: high dose chemoradiotherapy

Interventions

high dose chemoradiotherapyRADIATION

Radiation therapy: 60 Gy at 2 Gy/Fx/d over 6 weeks, immediately followed by 28.8 Gy in 24 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 88.8 Gy. concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 2 and paclitaxel 45 mg/m2 over the duration (8 weeks) of radiation therapy. Adjuvant chemotherapy is planned 6 weeks after high dose chemoradiation.

high dose chemoradiotherapy

Eligibility Criteria

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

You may qualify if:

  • Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
  • Age 1 8-75.
  • Eastern Cooperative Oncology Group （ECOG） performance status 0 to 2.
  • Stage III ( American Joint Committee on Cancer AJCC, 7th ed.).
  • No prior radiation to the thorax that would overlap with the current treatment field.
  • Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin \>/= 10.0 g/dl, Platelet count \>/= 1 00,000/ mm\^3,absolute granulocyte count (AGC) ≥2 × 10\^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine \</ =1 .5 times ULN.
  • A signed informed consent must be obtained prior to therapy.
  • Induction chemotherapy is allowed.
  • Life expectancy more than 3 months

You may not qualify if:

  • Patients with any component of small cell lung carcinoma are excluded from this study.
  • Patients with evidence of a malignant pleural or pericardial effusion are excluded.
  • Prior radiotherapy that would overlap the radiation fields.
  • Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
  • Known hypersensitivity to paclitaxel.
  • Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
  • Conditions precluding medical follow-up and protocol compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Genernal Hospital

Shanghai, Shanghai Municipality, 210000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Officials

  • Tingfeng Chen, MD

    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    STUDY DIRECTOR

Central Study Contacts

Ningning Cheng, MD

CONTACT

37798364ningcnn@163.com

Yong Liu, MD

CONTACT

37798364drliuyrt@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director, department of radiation

Study Record Dates

First Submitted

July 15, 2018

First Posted

July 26, 2018

Study Start

July 1, 2018

Primary Completion

May 1, 2021

Study Completion

July 1, 2022

Last Updated

August 25, 2020

Record last verified: 2020-08

Locations

CN(1)