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Phase I Study of High Linear Energy Transfer (Neutron) Therapy Followed by Concurrent Chemotherapy and Standard Photon Thoracic RT (TRT) in Stage III NSCLC (Non-Small Cell Lung Cancer) Patients

Phase 1
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase I Study of High Linear Energy Transfer (Neutron) Therapy Followed by Concurrent Chemotherapy and Standard Photon Thoracic RT (TRT) in Stage III NSCLC (Non-Small Cell Lung Cancer) Patients

Inclusion Criteria:

- IIIA :

Histologic or cytologic diagnosis of ipsilateral mediastinal lymph node involvement, or
Tumors greater than 7 cm or with chest wall invasion, or involvement of one of the
following diaphragm, phrenic nerve, mediastinal pleura or parietal pericardium with hilar
or mediastinal lymph node involvement.

More than one mediastinal lymph node enlarged on CT scan and the same lymph nodes positive
on PET scans or Paralyzed left vocal cord with separate lung primary distinct from the
aorto-pulmonary lymph nodes on the CT scan.

Evidence of tumor extension into the mediastinum and/or mediastinal structures either at
the time of mediastinoscopy, bronchoscopy or on CT scans.


Histologic or cytologic diagnosis of N3 lymph node involvement; or Enlarged N3 lymph nodes
on CT scan that are positive on PET scan as well. Patient must not have extension of lymph
node involvement to cervical lymph nodes other than supraclavicular lymph nodes; or Right
sided primary with left vocal cord paralysis; or Patients with a nodules in the same lung
but no other areas of involvement. Patients with prior surgically resected stage I NSCLC
who did not receive any adjuvant therapy, who now have stage IIIA or B NSCLC will be

- Age ≥ 18 years

- SWOG performance status 0 or 1 (see Appendix)

- Adequate organ function as evidenced by Absolute neutrophil count of ≥ 1.5 x 10(9)/L,
Platelet count ≥ 100,000 x 109/L Serum creatinine ≤ 1.5 times the institutional upper
limit of normal (ULN), Calculated creatinine clearance (Cockcroft-Gault formula) of ≥
45mL/min, Serum bilirubin ≤ ULN, Transaminases (SGOT and/or SGPT) ≤ 1.5 times
institutional ULN and alkaline phosphatase ≤ 2.5 times ULN, FEV1 of ≥ 1 liter and
DLCO > 50% of predicted.

- Patient should undergo brain imaging (CT scan or MRI) to rule out brain metastases.

- Signed informed consent that details the investigational nature of the study
according to institutional and federal guidelines.

- Registered with Clinical Trials Office at Karmanos Cancer Institute/Wayne State

Exclusion Criteria:

- Prior chemotherapy, radiation for any malignancy in which they received any thoracic

- Patients with concurrent malignancy. Patients with prior or concurrent malignancy
will be allowed as long as the treating physician considers it unlikely to impact the
clinical outcome of the patient.

- Patients with peripheral neuropathy ≥ 2.

- Serious medical illness including but not limited to uncontrolled congestive heart
failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6
months of registration, history of chronic active hepatitis or history of HIV or an
active bacterial infection will not be eligible.

- Inability or unwillingness to take folic acid or Vitamin B12 or dexamethasone.

- Pregnant or lactating women. All pre-menopausal and peri-menopausal women should have
a urine test for pregnancy within a week of starting therapy. All patients of child
bearing potential should agree to use an effective contraceptive method.

- Patients should not participate in any other therapeutic investigational study while
taking part in this study.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess Dose levels (DLT & MTD)integrating 2 dose levels of neutron tx in 2 diff regimens of approx 12 pts/trt; If 1st dose level feasible but not 2nd dose level in either cohorts then 12 pts will be trted at 1st dose level for that particular cohort

Outcome Description:

Lab value chgs (CBC w/diff, electrolytes, serum cr., calc. cr. clearance, bilirubin, AST, ALT, ca, mg, LDH, albumin)& for AE's-wks. 2, 5, 6, 8 & 1 mth. after therapy. Dose Limiting Toxicities (DLT): Gr 3/4 non-hematologic tox that is trtment related; Gr 4 thrombocytopenia, Gr 3/4 neutropenic fever or gr 4 neutropenia lasting > 7 days. Assess 2 dose levels, the maximum tolerated dose (MTD) of neutron therapy-dose at which < 33% of the pts. experience DLT.

Outcome Time Frame:

up to one month after therapy

Safety Issue:


Principal Investigator

Shirish M. Gadgeel, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

August 2011

Completion Date:

December 2011

Related Keywords:

  • Lung Cancer
  • Squamous Cell
  • Non-squamous cell
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms