Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer

NCT02568033 | Unknown Early Phase 1

• 1 other identifier: 13-130
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Disease free progression

  Local control will be evaluated at end of treatment (4-6 months) and then at regular follow up intervals.

  4-6 months

• Toxicity (Treatment related side effects)

  Treatment related side effects will be monitored

  4-5 months

Study Arms (1)

A

EXPERIMENTAL

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.

Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin; Drug: Docetaxel; Drug: Paclitaxel; Radiation: stereotactic radiosurgery

Interventions

Pemetrexed DRUG

Also known as: Alimta

A

Carboplatin DRUG

A

Cisplatin DRUG

A

Docetaxel DRUG

Also known as: taxotere

A

Paclitaxel DRUG

Also known as: taxol

A

stereotactic radiosurgery RADIATION

Also known as: CK, cyberknife, cyber knife

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

MD Anderson Cancer Center at Cooper

Camden, New Jersey, 08103, United States

RECRUITING

Related Publications (1)

• Kubicek GJ, Khrizman P, Squillante C, Callahan K, Xu Q, Abouzgheib W, Boujaoude Z, Patel A, Hageboutros A. Stereotactic Body Radiotherapy and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer: Single Arm Phase 2 Study. Am J Clin Oncol. 2022 Mar 1;45(3):129-133. doi: 10.1097/COC.0000000000000892.

  PMID: 35195562 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Carboplatin; Cisplatin; Docetaxel; Paclitaxel; Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Kimberly Krieger

CONTACT

856-735-6237

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 5, 2015
• Study Start: October 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 31, 2017

Record last verified: 2016-07

Locations

US (1)