Non Small Cell Lung CancerPhase 2NCT03699033
Hypofractionated Radiotherapy With Carboplatin and Paclitaxel in Non-Small Cell Lung Cancer
A Phase 2 study testing 2.5 Gy/fraction, Carboplatin and Paclitaxel in people with Non Small Cell Lung Cancer, run by Stephanie Smiddy at 1 site in United States.
Trial summary
Single center, single arm, Phase II study designed to evaluate the feasibility of hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with 4D PET/CT-based radiation treatment planning and concurrent carboplatin and paclitaxel in Stage IIIA or Stage IIIB NSCLC subjects. 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?
- 2.5 Gy/fraction, Carboplatin and Paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Oct 2020
- 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
- Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC).
- Stage IIIA subjects who are considered eligible for resection following neoadjuvant chemoradiation are eligible for this study.
- No PET/CT evidence of metastatic disease.
- An MRI of the brain with contrast excluding intracranial metastatic disease (or CT with contrast if MRI is medically contraindicated). An MRI without contrast is only permitted if the subject cannot have contrast for medical reasons.
- If a pleural effusion is present, it must be tapped and confirmed to be cytologically negative. If an effusion is deemed too small to safely tap, the subject will be eligible.
- Subjects must have measurable or evaluable disease.
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- No prior thoracic radiotherapy.
- Age > 18 years at time of registration.
- ECOG Performance Status of 0-2 (Karnofsky performance scale ≥ 60).
- Hgb > 9 g/dL; ANC (absolute neutrophil count) > 1500/µl; platelets > 100,000 mcL.
- Subjects must sign study-specific informed consent form prior to registration.
- Radiation therapy and chemotherapy must start within 4 weeks of study enrollment.
Who cannot join
- Evidence of severe or uncontrolled psychiatric or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator.
- Active connective tissue disorders, such as active lupus or scleroderma.
- Known Acquired Immune Deficiency (HIV (+)/AIDS).
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regiment to harm nursing infants. Women of childbearing potential must agree to use medically approved and adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo, Eleanor N. Dana Cancer Center
Toledo, Ohio, 43614
About this study
Official title: A Phase II Trial of Hypofractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction to PET-avid Disease Combined With Carboplatin and Paclitaxel for Subjects With Stage IIIA or IIIB Non-Small Cell Lung Cancer
Single center, single arm, Phase II study designed to evaluate the feasibility of hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with 4D PET/CT-based radiation treatment planning and concurrent carboplatin and paclitaxel in Stage IIIA or Stage IIIB NSCLC subjects.
Read the detailed description
This study is designed to evaluate the feasibility of hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with 4D PET/CT-based radiation treatment planning and concurrent carboplatin and paclitaxel in Stage IIIA or Stage IIIB NSCLC subjects.
Hypofractionated IMRT allows escalation of the biological effective dose (BED) to the tumor and reduces the radiation treatment duration to 5 weeks. Increasing the BED without protracting the RT course may be a more effective means of dose escalation than simply increasing the total dose but using only 2 Gy/fraction, as was tested in RTOG 0617.
Investigators require the use of advanced treatment planning techniques, including 4D CT simulation, volume delineation utilizing PET/CT to identify gross disease and IMRT to minimize the total volume of normal tissue receiving a high dose of radiation.
As minimal published work has evaluated hypofractionated RT regimens for Stage III NSCLC with concurrent chemotherapy, investigators selected a moderately escalated dose/fraction of 2.5 Gy for evaluation in combination with concurrent carboplatin and paclitaxel.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- 2.5 Gy/fraction, Carboplatin, Paclitaxel
- Keywords
- Radiation, NSCLC, Hypofractionated, Carboplatin, Paclitaxel, IMRT, Fraction, Stage III, 4D PET/CT
- 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.
2.5 Gy/fractionRadiation
Hypofractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction to PET-avid Disease Combined with Carboplatin and Paclitaxel
CarboplatinDrug
The doses of chemotherapy to be given concurrently with conformal radiotherapy will be weekly paclitaxel (45 mg/m2) and carboplatin (AUC=2), respectively.
Consolidation chemotherapy with 2 cycles of carboplatin (AUC=6) and paclitaxel (200 mg/m2) should be administered following completion of concurrent chemoradiation.
PaclitaxelDrug
The doses of chemotherapy to be given concurrently with conformal radiotherapy will be weekly paclitaxel (45 mg/m2) and carboplatin (AUC=2), respectively.
Consolidation chemotherapy with 2 cycles of carboplatin (AUC=6) and paclitaxel (200 mg/m2) should be administered following completion of concurrent chemoradiation.
| Study group | Role | What they receive |
|---|---|---|
| Radiation | Experimental | 2.5 Gy/Fraction Receives: Radiation: 2.5 Gy/fraction; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv5.0)
Acute toxicities (toxicity during and within 90 days of radiation therapy) and delayed toxicities will be measured using CTCAE criteria, version 5.0. Acute toxicities are defined as those toxicities occurring during and within 90 days from the completion of radiotherapy and delayed toxicities are those that develop at least 90 days after the last dose of radiation
Measured: During and within 90 days of radiation therapy
Secondary outcomes (3)
Progression-free survival
Progression-free survival will be measured from the last day of radiation treatment until evidence of local or distant disease progression.
Measured: year 0 - year 2
Overall Survival
Overall survival will be measured from the last day of radiation treatment until death.
Measured: year 0 - year 5
Local control
Assessment of local control after treatment with radiotherapy combined with Carboplatin and Placlitaxel
Measured: year 0 - year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Oct 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Why it stopped: No patients available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephanie Smiddy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephanie Smiddy, University of Toledo Health Science Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699033
- Sponsor's protocol ID
- 202923
- Status last verified
- Oct 2018
- First submitted
- 3 Oct 2018
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Hypofractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction to PET-avid Disease Combined With Carboplatin and Paclitaxel for Subjects With Stage IIIA or IIIB Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03699033
- Acronym / sponsor ID
- 202923
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Radiation, NSCLC, Hypofractionated, Carboplatin, Paclitaxel, IMRT, Fraction, Stage III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stephanie SmiddyUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single center, single arm, Phase II study designed to evaluate the feasibility of hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with 4D PET/CT-based radiation treatment planning and concurrent carboplatin and paclitaxel in Stage IIIA or Stage IIIB NSCLC subjects.
Detailed description
This study is designed to evaluate the feasibility of hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with 4D PET/CT-based radiation treatment planning and concurrent carboplatin and paclitaxel in Stage IIIA or Stage IIIB NSCLC subjects.
Hypofractionated IMRT allows escalation of the biological effective dose (BED) to the tumor and reduces the radiation treatment duration to 5 weeks. Increasing the BED without protracting the RT course may be a more effective means of dose escalation than simply increasing the total dose but using only 2 Gy/fraction, as was tested in RTOG 0617.
Investigators require the use of advanced treatment planning techniques, including 4D CT simulation, volume delineation utilizing PET/CT to identify gross disease and IMRT to minimize the total volume of normal tissue receiving a high dose of radiation.
As minimal published work has evaluated hypofractionated RT regimens for Stage III NSCLC with concurrent chemotherapy, investigators selected a moderately escalated dose/fraction of 2.5 Gy for evaluation in combination with concurrent carboplatin and paclitaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation | Experimental | Radiation: 2.5 Gy/fraction, Drug: Carboplatin, Drug: Paclitaxel2.5 Gy/Fraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC).
- Stage IIIA subjects who are considered eligible for resection following neoadjuvant chemoradiation are eligible for this study.
- No PET/CT evidence of metastatic disease.
- An MRI of the brain with contrast excluding intracranial metastatic disease (or CT with contrast if MRI is medically contraindicated). An MRI without contrast is only permitted if the subject cannot have contrast for medical reasons.
- If a pleural effusion is present, it must be tapped and confirmed to be cytologically negative. If an effusion is deemed too small to safely tap, the subject will be eligible.
Key exclusion criteria (4 listed)
- Evidence of severe or uncontrolled psychiatric or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator.
- Active connective tissue disorders, such as active lupus or scleroderma.
- Known Acquired Immune Deficiency (HIV (+)/AIDS).
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regiment to harm nursing infants. Women of childbearing potential must agree to use medically approved and adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2.5 Gy/fractionHypofractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction to PET-avid Disease Combined with Carboplatin and Paclitaxel | Radiation | Radiation |
| CarboplatinThe doses of chemotherapy to be given concurrently with conformal radiotherapy will be weekly paclitaxel (45 mg/m2) and carboplatin (AUC=2), respectively. Consolidation chemotherapy with 2 cycles of carboplatin (AUC=6) and paclitaxel (200 mg/m2) should be administered following completion of concurrent chemoradiation. | Drug | Radiation |
| PaclitaxelThe doses of chemotherapy to be given concurrently with conformal radiotherapy will be weekly paclitaxel (45 mg/m2) and carboplatin (AUC=2), respectively. Consolidation chemotherapy with 2 cycles of carboplatin (AUC=6) and paclitaxel (200 mg/m2) should be administered following completion of concurrent chemoradiation. | Drug | Radiation |
Primary outcome
Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv5.0)
Time frame: During and within 90 days of radiation therapy
Acute toxicities (toxicity during and within 90 days of radiation therapy) and delayed toxicities will be measured using CTCAE criteria, version 5.0. Acute toxicities are defined as those toxicities occurring during and within 90 days from the completion of radiotherapy and delayed toxicities are those that develop at least 90 days after the last dose of radiation
3 secondary outcomes
Progression-free survival
Time frame: year 0 - year 2
Overall Survival
Time frame: year 0 - year 5
Local control
Time frame: year 0 - year 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2.5 Gy/fraction, Carboplatin and Paclitaxel in people with Non Small Cell Lung Cancer, run by Stephanie Smiddy at 1 site in United States.
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 12 inclusion and 4 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: withdrawn, as of the sponsor's last update on 5 Nov 2020. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv5.0) (time frame: During and within 90 days of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2020.