Hypofractionated Radiotherapy With Carboplatin and Paclitaxel in Non-Small Cell Lung Cancer

NCT03699033 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 202923
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non Small Cell Lung Cancer

Keywords

Radiation; NSCLC; Hypofractionated; Carboplatin; Paclitaxel; IMRT; Fraction; Stage III; 4D PET/CT

Outcome Measures

Primary Outcomes (1)

• 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

  During and within 90 days of radiation therapy

Secondary Outcomes (3)

• Progression-free survival

  year 0 - year 2

• Overall Survival

  year 0 - year 5

• Local control

  year 0 - year 2

Study Arms (1)

Radiation

EXPERIMENTAL

2.5 Gy/Fraction

Radiation: 2.5 Gy/fraction; Drug: Carboplatin; Drug: Paclitaxel

Interventions

2.5 Gy/fraction RADIATION

Hypofractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction to PET-avid Disease Combined with Carboplatin and Paclitaxel

Radiation

Carboplatin DRUG

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.

Radiation

Paclitaxel DRUG

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.

Radiation

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stephanie Smiddy: lead

Study Sites (1)

University of Toledo, Eleanor N. Dana Cancer Center

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 9, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 5, 2020

Record last verified: 2018-10

Locations

US (1)