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Non-Small Cell Lung CancerPhase 2NCT02841228

Intensity-modulated Radiotherapy (IMRT) With Simultaneous Integrated Boost (SIB) for Inoperable Non-small-cell Lung Cancer

A Phase 2 study testing IMRT + SIB + Chemotherapy in people with Non-Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Lung cancer is one of the most common cancer and the leading causes of cancer death in worldwide. Approximately 80% of NSCLC were inoperable. The prognosis of patients with LA-NSCLC remains disappointing. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
IMRT + SIB + Chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
Nov 2015to Nov 2018
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed NSCLC, inoperable stages IIA-IIIB, according to American Joint Committee on Cancer （AJCC）Cancer Stage 7th
  • Performance status 0 to 2, ≤5% weight loss within the past 6 months
  • A forced expiratory volume at 1 second of ≥ 1 L
  • Life expectancy > 3 months
  • No invasion of large vessels, heart, esophagus, spinal cord.
  • Based on conformal treatment planning, the volume of lung at or exceeding 20 Gy (V20) must have been≤30%, the mean esophagus dose≤34 Gy, and the volume of esophagus exceeding 55 Gy (V55)≤30%
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  • Tolerable and agree for Intensity-Modulated Radiation Therapy（IMRT） and concurrent chemoradiotherapy
  • Without severe other diseases
  • Informed consent

Who cannot join

  • Had received prior thoracic radiotherapy
  • Supraclavicular lymph node metastasis, pleural or pericardial effusions, and superior vena cava syndrome
  • Pregnant and lactating women
  • Serious complications
  • Other primary malignancies

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Hunan province tumor pospital

    Changsha, Hunan

    shengqi wu, M.D., 13807316075, wushengqi@hnszlyy.com

    Recruiting

Other trials in China

About this study

Official title: Intensity-modulated Radiotherapy (IMRT) With Simultaneous Integrated Boost (SIB) Dose Escalation to the Gross Tumor Volume (GTV) With Concurrent Chemotherapy for Stage II/III Non-small Cell Lung Cancer (NSCLC)

Lung cancer is one of the most common cancer and the leading causes of cancer death in worldwide. Approximately 80% of NSCLC were inoperable. The prognosis of patients with LA-NSCLC remains disappointing. Investigators hypothesized that use of simultaneous integrated boost intensity modulated radiotherapy (SIB-IMRT) technology can safety increasing the radiation dose and benefit for inoperable NSCLC patients.

Read the detailed description

Lung cancer is one of the most common cancer and the leading causes of cancer death in patients worldwide. Approximately 80% of NSCLC were inoperable. Concurrent chemo-radiation therapy (CCRT) is a standard treatment for locally advanced NSCLC who are not candidates for surgery. Nevertheless, the prognosis of patients with locally advanced NSCLC (LA-NSCLC) is still poor. Local control (LC) after CCRT is one of the most important prognostic factors. Local failure is common after standard-dose chemoradiation for NSCLC. Studies of stereotactic body radiation therapy (SBRT) have shown a steep dose response in treating early-stage lung cancer. Improving the total dose and shortening the overall treatment time may be effective for improving the LC rates. However, problems remain due to the toxicity to adjacent critical structures (e.g,lung,heart, esophagus), the target volumes usually limits the doses escalated that cannot be safely delivered by conventional radiotherapy techniques. In order to avoid the acute and late radiation toxicity of normal tissues, different dose prescriptions can be delivered to different target volumes in the same fraction, which deliver a higher dose to the Gross Tumor Volume (GTV) and a relatively lower dose to the subclinical disease. The technique is called simultaneous integrated boost intensity modulated radiotherapy (SIB-IMRT).

Investigators hypothesized that use of SIB-IMRT technology can safety increasing the radiation dose and benefit for inoperable NSCLC patients.

Being tested
IMRT + SIB + Chemotherapy
Keywords
SIB-IMRT, NSCLC, Radiochemothearpy
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.

  • IMRT + SIB + ChemotherapyRadiation

    For all patients, the dose to the PTV will be kept constant at 60 Gy in 30 fractions at 2.0 Gy per fraction , SIBV will be kept constant at 72 Gy in 30 fractions at 2.4 Gy per fraction. Fractions given once a day, 5 times a week for six weeks. All patients will receive standard concurrent chemotherapy.

Study groups in NCT02841228
Study groupRoleWhat they receive
IMRT + SIB + ChemotherapyExperimentalFor all patients, the dose to the PTV will be kept constant at 60 Gy in 30 fractions at 2.0 Gy per fraction, SIBV will be kept constant at 72 Gy in 30 fractions at 2.4 Gy per fraction. Fractions given once a day, 5 times a week for six weeks. All patients will receive standard concurrent chemotherapy.
Receives: Radiation: IMRT + SIB + Chemotherapy

What is being measured

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

  1. Progression free survival (PFS)

    Progression free survival is defined as the time (in months) from the date of admission to the date of progression or last follow-up

    Measured: up to 12 months

Secondary outcomes (3)

  1. Treatment-related toxicities

    To assess the pulmonary, oesophageal and cardiac grade 3 or 4 toxicity occurring up to 3 and 6 months after radiotherapy, according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Measured: up to 6 months

  2. Overall Response Rate (ORR)

    ORR is defined as the proportion of participants with an overall response of complete response (CR) of any duration, partial response (PR) of any duration for a minimum of 3 months from start of treatment. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions; progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; stable disease (SD): no change or small changes that do not meet previously given criteria for CR, PR or PD.

    Measured: up to 3 months

  3. Overall survival (OS)

    Overall survival is defined as the time (in months) from the date of admission to the date of death from any cause or last follow-up

    Measured: up to 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 posted22 Jul 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionNov 2017 (estimated)
  4. Study completionNov 2018 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02841228
Sponsor's protocol ID
SIB-IMRT
Status last verified
Jul 2016
First submitted
5 Jul 2016
Last updated
22 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Yang W, Zeng B, Qiu Y, Tan J, Xu S, Cai Y, Zhou Y, Liu Z, Luo J, Wang H. A Dosimetric Comparison of Dose Escalation with Simultaneous Integrated Boost for Locally Advanced Non-Small-Cell Lung Cancer. Biomed Res Int. 2017;2017:9736362. doi: 10.1155/2017/9736362. Epub 2017 May 28.

    PubMed 28630876

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMRT + SIB + Chemotherapy in people with Non-Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.

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 9 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: status not confirmed, as of the sponsor's last update on 22 Jul 2016. 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 China. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: up to 12 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 NCT02841228, 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 Jul 2016.

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