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Non-small Cell Lung CancerPhase 2NCT01066234

Adjuvant CCRT vs CT in Minimal N2 NSCLC

A Phase 2 study testing concurrent chemoradiotherapy and chemotherapy only in people with Non-small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
concurrent chemoradiotherapy and chemotherapy only
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteSouth Korea
Study dates
23 Oct 2017to 18 Jan 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of stage IIIA(N2) NSCLC that was completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve lobectomy through any incision (thoracoscopic or video-assisted thorascopic surgery approaches were acceptable)
  • "Pathologic N2" disease (involvement of N2 nodes can only be determined at the time of surgical exploration or postoperative pathologic analysis)
  • Age ≥18years
  • No known residual disease (negative resection margin and no extracapsular invasion of lymph node metastasis)
  • ECOG performance status of 0 to 1
  • No previous chemotherapy or RT
  • Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min
  • Written informed consent form

Who cannot join

  • Patients with preoperative mediastinoscopic N2 positive disease
  • Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
  • Patients with post-obstructive pneumonia or uncontrolled serious infection
  • Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
  • Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized Phase II Study of Adjuvant Concurrent Chemoradiotherapy vs Chemotherapy Alone in Completely Resected Microscopic N2 Non-small Cell Lung Cancer

This study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC

Read the detailed description

Approximately 15% of patients with non-small cell lung cancer are diagnosed with stage IIIA-N2 disease. However, this subgroup is heterogeneous, with lymph nodes that are only microscopically invaded to those that are radiologically visible with bulky ipsilateral mediastinal lymph node involvement. Surgical resection in selected patients results in 5-year survival rates of 7-24%.

The standard treatment for locally advanced clinical N2 disease is definitive concurrent chemoradiotherapy or induction chemotherapy (± radiation) followed by operation. However, in some patients, N2 status could be confirmed only after curative operation without any evidence of N2 diseases through preoperative evaluation methods (CT, PET, mediastinoscopy). We usually define those N2 disease found only after curative operation as microscopic N2, and do adjuvant chemotherapy, radiotherapy or concurrent chemoradiotherapy. However, little data about the adjuvant therapy for completely resected N2 disease have been available, Hence, we propose a randomized phase II study of adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC.

Being tested
concurrent chemoradiotherapy, chemotherapy only
Keywords
Microscopic N2 Non-small Cell Lung Cancer, Paclitaxel, Carboplatin, Cisplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • concurrent chemoradiotherapyRadiation

    weekly paclitaxel 50mg/m2 plus weekly cisplatin 25mg/m2 5times with concurrent radiotherapy (5000rad/25fx) for 5 weeks followed by 2 cycles of 3-weekly paclitaxel (175mg/m2) plus cisplatin 80mg/m2.

  • chemotherapy onlyDrug

    four cycles of 3-weekly paclitaxel (175mg/m2) and carboplatin (AUC5.5).

Study groups in NCT01066234
Study groupRoleWhat they receive
concurrent chemoradiotherapyExperimentalNot described
Receives: Radiation: concurrent chemoradiotherapy
chemotherapy onlyActive comparatorNot described
Receives: Drug: chemotherapy only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival

    Measured: 36 months

Secondary outcomes (4)

  1. Overall survival (OS)

    Measured: 36 months

  2. Pattern of relapse

    Measured: 36 months

  3. Toxicity profile

    Measured: 36 months

  4. Quality of life (QOL)

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2010 (estimated)
  2. Study start23 Oct 2017
  3. Primary completion18 Jan 2021
  4. Study completion18 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01066234
Sponsor's protocol ID
2009-04-004
Status last verified
Mar 2021
First submitted
8 Feb 2010
Last updated
22 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sun JM, Noh JM, Oh D, Kim HK, Lee SH, Choi YS, Pyo H, Ahn JS, Jung SH, Ahn YC, Kim J, Ahn MJ, Zo JI, Shim YM, Park K. Randomized Phase II Trial Comparing Chemoradiotherapy with Chemotherapy for Completely Resected Unsuspected N2-Positive Non-Small Cell Lung Cancer. J Thorac Oncol. 2017 Dec;12(12):1806-1813. doi: 10.1016/j.jtho.2017.09.1954. Epub 2017 Sep 28.

    PubMed 28962948

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing concurrent chemoradiotherapy and chemotherapy only in people with Non-small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01066234, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.

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