Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer

NCT ID: NCT00840749

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2013-03-31

Brief Summary

Lung cancer remains the most frequent cause of cancer death in both men and women in the world. Surgical resection using lobectomy with mediastinal lymph node dissection or sampling has been a standard of care for operable early stage NSCLC. Several studies have reported high local control and survival using SBRT in stage I NSCLC patients. SBRT is now an accepted treatment for medically inoperable patients with stage I NSCLC and patients with operable stage I lung cancer are entered on clinical protocols. The purpose of this study is to conduct a phase III randomized study to compare CyberKnife SBRT with surgery, the current standard of care for stage I operable NSCLC.

Detailed Description

Objectives:

Primary Goal: To compare overall survival at 3 years.

Secondary goals:

1. To compare disease specific survival at 3 years.

2. To compare 3 year progression free survival at the treated primary tumor site

3. To compare grade 3 and above acute and/or chronic toxicities.

4. To evaluate predictive value of pre and post treatment PET scan in clinical outcome.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CyberKnife Stereotactic Radiotherapy

Group Type: EXPERIMENTAL

CyberKnife Stereotactic Radiotherapy

Intervention Type: RADIATION

Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy

Surgery

Group Type: ACTIVE_COMPARATOR

Surgery

Intervention Type: PROCEDURE

Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings

Interventions

CyberKnife Stereotactic Radiotherapy

Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy

Intervention Type: RADIATION

Surgery

Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings

Intervention Type: PROCEDURE

Other Intervention Names

CyberKnife SBRT, CyberKnife SRT, CyberKnife SRS; Open thoracotomy, video assisted thoracotomy (VATS)

Eligibility Criteria

Inclusion Criteria

1. Histological confirmation of non-small cell cancer will be required by either biopsy or cytology. The following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma with or without BAC features, large cell carcinoma with or without neuroendocrine features, neuroendocrine carcinoma, bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified.

2. Eligible patients must have appropriate staging studies identifying them as specific subsets of the revised IASCL state IA or IB based on only one of the following combinations of TNM staging:

T1, N0, M0 or T2 (<=4 cm), N0, M0

3. A PET/CT scan is required. Patients with hilar or mediastinal lymph nodes with short axis diameter < 1 cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with > 1 cm short axis diameter of hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. Solitary pulmonary lesions <4 mm will not be considered significant.

4. The patients must be considered a reasonable candidate for surgical resection of the primary tumor. Standard justification for deeming a patient medically operable based on pulmonary function for surgical resection of NSCLC may include any of the following: Baseline FEV1 > 40% predicted, post-operative predicted FEV1 > 30% predicted, diffusion capacity > 40% predicted, absent baseline hypoxemia and/or hypercapnia, exercise oxygen consumption > 50% predicted, absent severe pulmonary hypertension, absent severe cerebral, cardiac, or peripheral vascular disease, and absent severe chronic heart disease.

5. Patients must be ≥ 18 years of age.

6. The patient's Zubrod performance status must be Zubrod 0-2.

7. Mandatory staging studies: Must be done within 8 weeks prior to study entry

8. Patients must sign a study-specific consent form.

9. Patients (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study.

Exclusion Criteria

1. Patients with primary tumors > 4 cm;

2. Patients with well-differentiated neuroendocrine carcinoma (carcinoid tumor)

3. Direct evidence of regional or distant metastases after appropriate staging studies, or synchronous primary or prior malignancy in the past 5 years other than nonmelanomatous skin cancer or in situ cancer;

4. Previous lung or mediastinal radiotherapy;

5. Plans for the patient to receive other concomitant local therapy (including standard fractionated radiotherapy and surgery) while on this protocol except at disease progression;

6. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus;

7. Cannot achieve acceptable SRT planning to meet minimal requirement of target coverage and dose-volume constraints of critical structures (see RT techniques).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: collaborator

Accuray Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jack Roth, M.D.

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Community Regional Medical Center

Fresno, California, United States

Penrose Cancer Center

Colorado Springs, Colorado, United States

Denver CyberKnife

Lone Tree, Colorado, United States

Jupiter Medical Center

Jupiter, Florida, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Parkview Cancer Center

Fort Wayne, Indiana, United States

Central Baptist Hospital

Lexington, Kentucky, United States

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

St. Mary's of Michigan

Saginaw, Michigan, United States

St. Mary's Duluth Clinic Health System

Duluth, Minnesota, United States

Saint Louis University

St Louis, Missouri, United States

St. Mary's

Reno, Nevada, United States

St. Luke's Episcopal Hospital

Houston, Texas, United States

U.T. M.D. Anderson Cancer Center

Houston, Texas, United States

Ruikang Hospital

Nanning, Guangxi, China

Tianjin Cancer Institute and Hospital

Hexi Linchang, Tianjin Municipality, China

Centre Oscar Lambret

Lille, , France

Centre Antoine Lacassagne

Nice, , France

CyberKnife Center of WanFang Medical Hospital

Taipei, , Taiwan

Countries

United States; China; France; Taiwan

References

Park S, Kim HJ, Park IK, Kim YT, Kang CH. Stereotactic ablative radiotherapy versus surgery in older patients with stage I lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):74-80. doi: 10.1093/ejcts/ezab045.

Reference Type: DERIVED

PMID: 33668061 (View on PubMed)

Chang JY, Senan S, Paul MA, Mehran RJ, Louie AV, Balter P, Groen HJ, McRae SE, Widder J, Feng L, van den Borne BE, Munsell MF, Hurkmans C, Berry DA, van Werkhoven E, Kresl JJ, Dingemans AM, Dawood O, Haasbeek CJ, Carpenter LS, De Jaeger K, Komaki R, Slotman BJ, Smit EF, Roth JA. Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomised trials. Lancet Oncol. 2015 Jun;16(6):630-7. doi: 10.1016/S1470-2045(15)70168-3. Epub 2015 May 13.

Reference Type: DERIVED

PMID: 25981812 (View on PubMed)

Other Identifiers

STARS

Identifier Type: -

Identifier Source: org_study_id