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

July 19, 2016 updated by: Hui Wang, Hunan Province Tumor Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan province tumor pospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed NSCLC, inoperable stages IIA-IIIB, according to American Joint Committee on Cancer （AJCC）Cancer Stage 7th
  2. Performance status 0 to 2, ≤5% weight loss within the past 6 months
  3. A forced expiratory volume at 1 second of ≥ 1 L
  4. Life expectancy > 3 months
  5. No invasion of large vessels, heart, esophagus, spinal cord.
  6. 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%
  7. Tolerable and agree for Intensity-Modulated Radiation Therapy（IMRT） and concurrent chemoradiotherapy
  8. Without severe other diseases
  9. Informed consent

Exclusion Criteria:

  1. Had received prior thoracic radiotherapy
  2. Supraclavicular lymph node metastasis, pleural or pericardial effusions, and superior vena cava syndrome
  3. Pregnant and lactating women
  4. Serious complications
  5. Other primary malignancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMRT + SIB + Chemotherapy
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.
Radiation: IMRT + SIB + Chemotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: up to 12 months
Progression free survival is defined as the time (in months) from the date of admission to the date of progression or last follow-up
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related toxicities
Time Frame: up to 6 months
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.
up to 6 months
Overall Response Rate (ORR)
Time Frame: up to 3 months
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.
up to 3 months
Overall survival (OS)
Time Frame: up to 36 months
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
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunan Province Tumor Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 22, 2016

Study Record Updates

Last Update Posted (Estimate)

July 22, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIB-IMRT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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