Hypofraction Radiotherapy for Locally Advanced Non-small Cell Lung Cancer

NCT05269485 | Recruiting Phase 1

• 1 other identifier: ky270
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Definitive concurrent chemoradiotherapy followed by durvalumab (Pacific protocol) has been the standard modality for stage III locally advanced non-small cell lung cancer. In spite of the median overall survival of 47.5 months, there still existed 38.5% and 6.9% patients who finally developed intra-thorax and extra-thorax recurrence respectively in long-term follow-up. The relatively low local control rate has been the bottleneck for further improvement of overall survival. Hypofraction radiotherapy has been validated to be able to increase the local control rate in two prospective trials. Therefore, this trial is designed to explore the safety and primary efficacy of hypofraction radiotherapy followed by immune checkpoint inhibitors for stage III locally advanced non-small cell lung cancer.

Conditions

Toxicity Due to Radiotherapy; Non-small Cell Lung Cancer

Keywords

hypofraction radiotherapy; non-small cell lung cancer; immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (3)

• Rate of radiation-induced pneumonitis (CTCAE V4.0)

  Rate of radiation-induced pneumonitis (CTCAE V4.0)

  1 to 2 years

• Rate of radiation-induced esophagitis (CTCAE V4.0)

  Rate of radiation-induced esophagitis (CTCAE V4.0)

  1 to 2 years

• Rate of myelosuppression (CTCAE V4.0)

  Rate of myelosuppression (CTCAE V4.0)

  1 to 2 years

Secondary Outcomes (3)

• 1 year locoregional control rate (RECIST 1.1)

  1 year

• 1 year progression-free rate (RECIST 1.1)

  1 year

• 1 year overall survival rate (RECIST 1.1)

  1 year

Study Arms (2)

High-dose hypofraction Arm

EXPERIMENTAL

Irradiation of 60-68Gy/15-17f is administered followed by one-year immunotherapy maintenance.

Radiation: High-dose fractionated radiotherapy

Low-dose hypofraction Arm

EXPERIMENTAL

Irradiation of 48Gy/12f is administered followed by one-year immunotherapy maintenance.

Radiation: Low-dose fractionated radiotherapy

Interventions

High-dose fractionated radiotherapy RADIATION

Patients in this arm would receive high-dose fractionated radiotherapy with 60-68Gy/15-17f with one-year immunotherapy maintenance.

High-dose hypofraction Arm

Low-dose fractionated radiotherapy RADIATION

Patients in this arm would receive high-dose fractionated radiotherapy with 48Gy/15-12f with one-year immunotherapy maintenance.

Low-dose hypofraction Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• Eastern Cooperative Oncology Group (ECOG) 0-1;
• Non-small cell lung cancer including squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, large-cell carcinoma;
• Wild-type of driven genes;
• Stage III (AJCC 8th Edition) confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and d Positron Emission Tomography (PET-CT);
• Surgically unresectable or deny of surgery;
• Signature of inform consent.

You may not qualify if:

• Younger than 18 years old or older than 70 years old;
• ECOG\>1;
• Small-cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma;
• Mutant type of driven genes;
• Non-stage III (AJCC 8th Edition) confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT;
• Surgically resectable;
• No signature of inform consent.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui Provicial Hospital

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Radiotherapy

Model Details: There are two parallel group with each of 18 patients. One group would receive high-dose hypofraction radiotherapy of 60-68Gy/15-17f and the other group would receive low-dose hypofraction radiotherapy of 48Gy/12f.

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: March 8, 2022
• Study Start: August 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)