Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

NCT00346320 | Completed DMC

• 3 other identifiers: BR25CAN-NCIC-BR25CDR0000486919
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 19

Brief Summary

RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that cannot be removed by surgery.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; adenocarcinoma of the lung; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer; large cell lung cancer; squamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Local tumor control rate at 2 years

  Overall tumor control rate will be assessed at 6 years

  2 years

Secondary Outcomes (6)

• Toxicity

  6 years

• Disease recurrence rates

  6 years

• Progression-free survival

  6 years

• Overall survival

  6 years

• Quality of life

  6 years

Study Arms (1)

Radiotherapy

EXPERIMENTAL

3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks

Radiation: 3-dimensional conformal radiation therapy

Interventions

3-dimensional conformal radiation therapy RADIATION

3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks

Radiotherapy

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage I or II peripheral disease * T1, N0, M0 * T2 (≤ 5 cm), N0, M0 * T3 (≤ 5 cm, chest wall primary tumor only), N0, M0 * No T2-T3 primary tumors \> 5 cm or any T1-T3 tumor of the mainstem bronchus involvement * No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose) * Hilar or mediastinal lymph nodes ≤ 1 cm considered N0 * Any of the following primary cancer types: * Squamous cell carcinoma * Adenocarcinoma * Large cell carcinoma * Bronchioloalveolar cell carcinoma * Non-small cell carcinoma not otherwise specified * Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable) * Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed * If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen * Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs * No ataxia telangiectasia PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Not pregnant or nursing * Able and willing to complete a quality of life questionnaire unless not literate in either English or French (i.e., a translator is required to comprehend the questions and reply) * No active systemic, pulmonary, or pericardial infection * No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix. * Previous diagnosis of cancer that is free of recurrence and metastases for ≥ 2 years and, in the opinion of the treating physician, does not have a substantial risk of recurrence allowed (including prior lung cancer) PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the area of the primary tumor * No prior or concurrent chemotherapy or immunotherapy for this tumor

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (19)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BCCA - Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BCCA - Vancouver Island Cancer Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Atlantic Health Sciences Corporation

Saint John, New Brunswick, E2L 4L2, Canada

Location

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, AIB 3V6, Canada

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Lakeridge Health Oshawa

Oshawa, Ontario, L1G 2B9, Canada

Location

Thunder Bay Regional Health Science Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University - Dept. Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

CHUQ-Pavillon Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Related Publications (1)

• Cheung P, Faria S, Ahmed S, Chabot P, Greenland J, Kurien E, Mohamed I, Wright JR, Hollenhorst H, de Metz C, Campbell H, Vu TT, Karvat A, Wai ES, Ung YC, Goss G, Shepherd FA, O'Brien P, Ding K, O'Callaghan C. Phase II study of accelerated hypofractionated three-dimensional conformal radiotherapy for stage T1-3 N0 M0 non-small cell lung cancer: NCIC CTG BR.25. J Natl Cancer Inst. 2014 Jul 29;106(8):dju164. doi: 10.1093/jnci/dju164. Print 2014 Aug.

  PMID: 25074417 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Patrick CF Cheung, MD, FRCPC

  Toronto Sunnybrook Regional Cancer Centre

  STUDY CHAIR

• Sergio L Faria, MD, PhD

  Montreal General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2006
• First Posted: June 29, 2006
• Study Start: August 2, 2006
• Primary Completion: February 28, 2012
• Study Completion: August 20, 2014
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (19)