CALGB 140503

KCCOP Protocol Summary

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please follow the "Full Protocol" link or contact KCCOP for complete protocol information.

Full Protocol
(members only)

Consent Form

HIPAA

CALGB 140503 - "A Phase III Randomized Trial of Lobectomy versus Sublobar Resection for Small (<2cm) Peripheral Non-Small Cell Lung Cancer"

NOTE: If pt is randomized to Lobectomy arm & surgeon plans to use VATS procedure, surgeon must be credentialed per protocol.

Treatment Plan (Supplied Drug: N/A)

PRE-REGISTRATION

Surgery

Confirm path dx of NSCLC & N0 status by frozen exam of levels 4, 7, & 10 on R side and 5 or 6, 7, & 10 on L side

RANDOMIZATION*

Lobectomy: If VATS lobectomy is planned, surgeons must be credentialed per protocol

Limited Resection (Segmentectomy or Wedge Resection)

* Done intra-operatively after determining pt eligibility. CRAs must be able to access the web-based CALGB regist system during surgery to obtain tx assignment & inform surgeon of the assignment at the site.

Eligibility

PRE-REGISTRATION

Perip lung nodule <2cm on pre-op CT scan, presumed to be lung cancer. Center of tumor (as seen on CT) must be located in outer 1/3 of lung on either transverse, coronal, or sagittal plane. No pure ground glass opacities or path confirmed N1 or N2 disease.
Tumor must be suitable for either lobar or sublobar resection (wedge or segment).
ECOG perf status 0-2.
No prior malignancy w/i 3 yrs except non-melanoma skin cancer, superficial bladder cancer, or cervical CIS.
No prior chemo or RT for this malignancy.
No locally advanced for mets disease.
Age >18.
PRIOR TO PRE-REGISTRATION REQUIREMENTS
- PE
- Perf status
- Tumor msmts
- PFTs
- Chest CT (w/i 42 days prior to pre-regist; see protocol for requirements)
- PET (prn) - (w/i 42 days prior to pre-regist; see protocol for requirements)
Signed informed consent.

INTRA-OPERATIVE RANDOMIZATION

Histol confirmation of NSCLC (if not already obtained).
Confirmation of N0 status by frozen section exam. R-side tumors require that nodes 4, 7, & 10 be sampled & diagnosed as N0. L-side tumors require that nodes 5 or 6, 7, & 10 be sampled & diagnosed as N0. Levels 4 & 7 nodes may be sampled by mediastinoscopy, EBUS &/or EUS, or at time of thoracotomy or VATS exploration. Nodes sampled previously by mediastinoscopy (or EBUS &/or EUS) either immediately prior to or w/i 6 wks of definitive surgery (thoracotomy or VATS) do not need to be resampled.