NCT03331575

Brief Summary

This protocol is a phase III randomized controlled trial (RCT) evaluating the efficacy of hypofractionated vs. conventionally fractionated concurrent chemo-radiotherapy for unresectable stage III non-small-cell 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
480

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2017

Typical duration for phase_3

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

First Submitted

Initial submission to the registry

October 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

3 years

First QC Date

October 31, 2017

Last Update Submit

November 1, 2017

Conditions

Unresectable Stage III Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Over survival(OS)

    3years

Secondary Outcomes (1)

  • Disease-free survival (DFS)

    3years

Other Outcomes (3)

  • Locoregional control survival (LCS)

    3years

  • Distant metastasis-free survival (DMFS)

    3 years

  • Treatment-related adverse even

    3 years

Study Arms (2)

Arm1(Hypofractionated Radiotherapy)

EXPERIMENTAL

Hypofractionated Radiotherap（PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx）, with concurrent chemotherapy : Cisplatin(20 mg/m2 d1) Docetaxel (20 mg/m2 d1),weekly, 6 cycles )

Radiation: Arm1 (Hypofractionated radiotherapy)

Arms2（Conventional Radiotherapy）

PLACEBO COMPARATOR

Conventional Radiotherapy（PTV-G60Gy/30Fx,2Gy/Fx; PTV-C 50.4Gy/30Fx, 1.8Gy/Fx）, with concurrent chemotherapy : Cisplatin(20 mg/m2 d1) Docetaxel (20 mg/m2 d1),weekly, 6 cycles )

Radiation: Arm1 (Hypofractionated radiotherapy)

Interventions

Arm1 (Hypofractionated radiotherapy)RADIATION

hypofractionated RT（PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx）, with concurrent chemotherapy : Cisplatin(20 mg/m2 d1) Docetaxel (20 mg/m2 d1),weekly, 6 cycles )

Arm1(Hypofractionated Radiotherapy)Arms2（Conventional Radiotherapy）

Eligibility Criteria

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

You may qualify if:

  • Male or female, aged 18 years to 75 years
  • .Histologically proven lung adenocarcinoma or squamous cell lung carcinoma of r Unresectable Stage III NSCLC(according to the TNM classification in theUnion for International Cancer Control (UICC) 7th ed.)
  • No prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) treatment or other targeted therapy
  • No prior thoracic RT
  • No severe perioperative complications and expected postoperative lifespan
  • ≥4 months
  • ECOG Performance Status 0-1
  • Voluntarily participated in this study and signed the informed consent form by himself or his agent. Had good compliance with the study procedures, and can cooperate with the relevant examination, treatment and follow-up

You may not qualify if:

  • Diagnosed with other prior or concurrent malignancies (neoplasm) except for basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years
  • Patients with any severe or uncontrolled systematic disease including severe cardiovascular, liver, kidney, hematopoietic, metabolic disease, or uncontrolled active infection that would preclude study participation
  • Patients with positive mental disorder that would preclude study participation;
  • Contradictory to chest radiotherapy
  • Pregnant or nursing women
  • Concurrent other anti-cancer treatment
  • Prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) treatment or other targeted therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

26S proteasome non-ATPase regulatory subunit 13

Central Study Contacts

Xiaolong Fu, PhD

CONTACT

862122200000xlfu1964@126.com

Qin Zhang, PhD

CONTACT

8618017321606zhangq0616@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Xiaolong Fu

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 6, 2017

Study Start

November 1, 2017

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

CN(1)