Recruiting
Early Phase 1

Stereotactic Radiosurgery & Chemotherapy

Sponsor:

The Cooper Health System

Code:

NCT02568033

Conditions

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pemetrexed

Carboplatin

Cisplatin

Docetaxel

Paclitaxel

Study Details

Brief summary:

This is a pilot study looking at using stereotactic radiosurgery and full dose chemotherapy to treat stage II and III lung cancer that is not amendable to surgical resection.

Conditions

Non Small Cell Lung Cancer

Study ID

NCT02568033

Start date

Oct, 2013

Status verified date

Jul, 2016

Completion date

Oct, 2017

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Nonsmall cell lung cancer (NSCLC) (any histology)
  • unresectable stage II
  • Stage III
  • Tumor less than 8 cm
  • Karnofsky performance scale (KPS) of 50 or better
  • Three or fewer mediastinal or hilar lymph nodes

Exclusion criteria

  • Small cell lung cancer (SCLC)
  • Stage I and stage IV patients
  • Stage II patients eligible for surgical resection
  • Concurrent severe disease that the treating physician feels will interfere with therapy this can include significant cardiovascular or pulmonary disease.
  • KPS 40 or less (bed bound)
  • Tumor size greater than 8 cm
  • Inability to safely treat target lesions (at discretion of treating physician, this would most likely be secondary to not being able to place fiducial markers for tracking)
  • Four or more medisatinal or hilar lymph nodes

Study Design

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A

Chemotherapy:

for Non-Squamous Cell: Pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of 21 day cycle or Carboplatin AUC6 and Paclitaxel 75 mg/m2 on day 1 of 21 day cycle

for Squamous Cell: Cisplatin 75 mg/m2 and docetaxel 75mg m2 day 1 of 21 day cycle or Carboplatin AUC6 and paclitaxel 200 mg/m2 day 1 of 21 day cycle

Radiation- Stereotactic radiosurgery Peripheral Lung lesion: 60 Gy over 3 fractions Central Lung lesion: 50 Gy over 5 fractions Hilar and Mediastinal LNs 40-50Gy over 5 fractions

Schedule is:

2 cycles of chemotherapy, followed by SRS, followed by 2 additional cycles of chemotherapy.

Interventions

Pemetrexed

Carboplatin

Cisplatin

Docetaxel

Paclitaxel

stereotactic radiosurgery

Primary outcome measure

  • Disease free progression [ Time Frame: 4-6 months ]
  • Toxicity (Treatment related side effects) [ Time Frame: 4-5 months ]

Central Contacts and Locations

Central contacts

Kimberly Krieger

856-735-6237

Locations

MD Anderson Cancer Center at Cooper

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Kim Krieger

856-735-6237

More Information

Sponsor

The Cooper Health System

Last update posted

Jan 31, 2017

Last verified

Jul, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cooper Health System on 2017-01-31.