NCT02367443

Brief Summary

This is a phase I/II trial on concomitant RT-full dose CHT using accelerated hypofractionation schedule as currently being in routine use in Poland for sequential combination or RT alone. Objectives of the study are: to estimate rate of grade ≥ 3 CTCAE adverse effects related to treatment and to estimate tumor control, progression free-survival, and overall survival in patients treated with this regimen. Stage III NSCLC patients are treated according to the following schedule: RT: 58.8 Gy in 21 fractions (2.8 Gy/fraction, 5 times a week, 6 times in the third week; CHT concomitant with RT (2 cycle of Cisplatinum and Vinorelbine, every 21 days). Feasibility of the studied approach is evaluated by scoring the toxicity during RT-CHT and therafter, as well as percentage of treatment completion; efficacity is evaluated by estimation of local control and survival. If toxicity and efficacity are similar or better than those observed in modern series of conventionally fractionated RT-CHT, the studied regimen will become a routine treatment schedule in our institution in order to spare RT resources. In the future, a randomized comparison of the studied schedule with conventionally fractionated RT-CHT for locally advanced NSCLC is also planned.

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
92

participants targeted

Target at P50-P75 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_1 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

March 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

5.6 years

First QC Date

February 12, 2015

Last Update Submit

November 4, 2019

Conditions

Non-small Cell Lung Cancer

Keywords

radiotherapytherapeutic useRadiationnon-small cell lung cancerchemotherapy

Outcome Measures

Primary Outcomes (1)

  • Toxicity

    Grade III and higher

    3 years

Secondary Outcomes (1)

  • Survival

    3 years

Study Arms (1)

one group

EXPERIMENTAL

Radiation: Hypofractionated accelerated Radiotherapy with concomitant full dose Chemotherapy

Radiation: Radiation

Interventions

RadiationRADIATION

Radiation: Accelerated Hypofractionated radiotherapy with full dose Chemotherapy

one group

Eligibility Criteria

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

You may qualify if:

  • Pathological or cytological confirmation of the diagnosis of NSCLC
  • Confirmation of clinical stage III based on: clinical examination, CT of the chest and abdomen (PET-CT highly recommended), bronchoscopy, CT or MRI of the brain if suspicion of brain metastases
  • No abnormalities in blood count precluding administration of full doses of Cisplatin and Vinorelbine (Neutrophils ≥1.5x109/L; Platelets ≥100 x109/L; Hemoglobin \>11 g/dl)
  • No abnormalities in renal and hepatic function precluding administration of full doses of Cisplatin and Vinorelbine (creatinine clearance \>50 ml/minute, aminotransferases \< 1.5 of upper limit of normal value)
  • Age \<75
  • KPS: 80-100
  • FEV1 \> 1 liter (except cases with very low body surface, when FEV1 should be \>40%)
  • No chronic diseases causing contraindication to the use of CHT
  • No previous RT on the thoracic region
  • Informed consent of patient for the participation in the study

You may not qualify if:

  • Presence of clinically examined supraclavicular lymph nodes
  • Malignant pleural or pericardial effusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Independent Public Health Care Facility and Warmian & Mazurian Oncology Centre

Olsztyn, 10-228, Poland

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Phenomena

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
Prof.

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 20, 2015

Study Start

March 1, 2014

Primary Completion

October 1, 2019

Study Completion

January 1, 2020

Last Updated

November 6, 2019

Record last verified: 2019-11

Locations

PL(1)