NCT01947062

Brief Summary

Treatment of locally advanced and metastatic squamous cell carcinoma of the lung involves the use of chemotherapy as the therapeutic mainstay. Platinum-etoposide regimens (such as cisplatin-etoposide) are the most commonly used chemotherapeutic regimen, which is delivered intravenously in the standard three-weekly intervals. Recent interest in oral metronomic chemotherapy has arisen, especially due to its beneficial effects in delaying disease progression among heavily pre-treated patients with various malignancies. This study attempts to combine the use of metronomic chemotherapy concurrently during standard intravenous chemotherapy.

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
60

participants targeted

Target at below P25 for phase_3 lung-cancer

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_3 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

First Submitted

Initial submission to the registry

September 10, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

8 months

First QC Date

September 10, 2013

Last Update Submit

September 17, 2013

Conditions

Lung CancerSquamous Cell Carcinoma of the LungLocally Advanced and Metastatic Squamous Cell Carcinoma of the Lung

Keywords

NSCLCMetronomic chemotherapyMetronomic cyclophosphamide

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    12 months on average

Secondary Outcomes (1)

  • Response rate

    12 months on average

Study Arms (2)

Standard intravenous chemotherapy

ACTIVE COMPARATOR

Patients will receive standard intravenous chemotherapy based on cisplatin and etoposide.

Drug: Intravenous Cisplatin & etoposide

Intravenous with metronomic chemotherapy

EXPERIMENTAL

Patients will receive both intravenous (cisplatin and etoposide based) and metronomic chemotherapy (with oral cyclophosphamide).

Drug: Intravenous Cisplatin & etoposide along with oral cyclophosphamide

Interventions

Intravenous Cisplatin & etoposideDRUG

Patients will receive standard intravenous cisplatin and etoposide based chemotherapy, for a total of six cycles, delivered at three-weekly intervals. In each cycle, the dose of cisplatin will be at 50mg/m2 on days 1 \& 2. The dose of etoposide will be 100mg/m2 on days 1, 2 \& 3.

Also known as: Control arm, Standard intravenous chemotherapy
Standard intravenous chemotherapy
Intravenous Cisplatin & etoposide along with oral cyclophosphamideDRUG

Patients will be treated with oral cyclophosphamide at a daily dose of 50mg. Patients will also receive standard intravenous cisplatin and etoposide based chemotherapy, for a total of six cycles, delivered at three-weekly intervals. In each cycle, the dose of cisplatin will be at 50mg/m2 on days 1 \& 2. The dose of etoposide will be 100mg/m2 on days 1, 2 \& 3.

Also known as: Experimental arm, Intravenous with metronomic chemotherapy
Intravenous with metronomic chemotherapy

Eligibility Criteria

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

You may qualify if:

  • Histopathologically proven squamous cell carcinoma of the lung
  • Surgically unresectable or metastatic disease

You may not qualify if:

  • Severe life limiting diabetes, hypertension or cardiac co-morbidities
  • Co-existing tuberculosis
  • Brain metastases at presentation
  • Non-consenting patients
  • Previously treated with any regimen of chemotherapy for existing or previous malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swami Rama Cancer Hospital & Research Institute

Haldwani, Nainital, Uttarakhand, 263139, India

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

EtoposideCyclophosphamide

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Central Study Contacts

Swaroop Revannasiddaiah, MD

CONTACT

+91swarooptheone@gmail.com

Kailash C Pandey, MD

CONTACT

+91drkcp89@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Radiotherapy & Clinical Oncology

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 20, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

October 1, 2014

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations

IN(1)