Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Cisplatin

Immunomodulating Agents

Immunologic Factors

In keeping the same total radiation dose (60Gy), we escalate the fraction dose to find the maximum tolerable fraction dose.

1. Level 1: DT 4500cGy/15 daily fractions/300cGy in the first course，DT 1500cGy/5 daily fractions/300cGy in the second course;
2. Level 2: DT 4000cGy/10 daily fractions/400cGy in the first course， DT 2000cGy/5 daily fractions/400cGy in the second course;
3. Level 3: DT 3000cGy/6 daily fractions/500cGy in the first course， DT 3000cGy/6 daily fractions/500cGy in the second course.

RT is delivered using the IMRT technique with daily cone-beam CT image guidance. The dose limitation of organ at risk (OAR) are shown in Table 1. Patients receive a weekly infusion of docetaxel (25mg/m2) and cisplatin (25mg/m2) during RT. Consolidative immunotherapy (PD-1 or PD-L1 inhibitor) up to 1 year is administered for those without disease progression after HRT-CHT.

Split-course adaptive HRT-CHT is administered at the following three dose levels:

1. Level 1: DT 4500cGy/15 daily fractions/300cGy in the first course，DT 1500cGy/5 daily fractions/300cGy in the second course;
2. Level 2: DT 4000cGy/10 daily fractions/400cGy in the first course， DT 2000cGy/5 daily fractions/400cGy in the second course;
3. Level 3: DT 3000cGy/6 daily fractions/500cGy in the first course， DT 3000cGy/6 daily fractions/500cGy in the second course.

Hypofractionated radiotherapy

weekly infusion of docetaxel (25mg/m2) and cisplatin (25mg/m2) during RT

Concurrent chemotherapy

Consolidative immunotherapy (PD-1 or PD-L1 inhibitor) up to 1 year is administered for those without disease progression after HRT-CHT.

Consolidation immunotherapy

Hui Liu, Professor

This Phase 1 trial aimed to determine the maximum tolerated fraction dose (MTD) of hypofractionated radiotherapy (hypo-RT) combined with concurrent chemotherapy and subsequent consolidation immune checkpoint inhibitors (cICI) for patients with locally advanced non-small cell lung cancer (LA-NSCLC).

Fraction Dose Escalation of Hypo-fractionated Radiotherapy in LANSCLC

Fraction Dose Escalation of Hypofractionated Radiotherapy With Concurrent Chemotherapy and Subsequent Consolidation Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: a Phase 1 Study

The maximum tolerated fraction dose was defined as the highest DL in which \<=2 patients of the 6 treated patients experienced G3+ toxicity and \<=1 patient experienced G4+ toxicity within 12 months after RT. If a patient had multiple types of toxicities, only the highest grade of toxicity was counted.

Proportion of patients with PR and CR at 2 months after radiotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fraction Dose Escalation of Hypo-fractionated Radiotherapy in LANSCLC	NCT04951063	Locally Advance...	Hypofractionate... Concurrent chem... Consolidation i...	18 Years - 75 Years	Sun Yat-sen University
Fraction Dose Escalation of Hypo-fractionated Radiotherapy in LANSCLC	NCT04951063	Locally Advance...	Hypofractionate... Concurrent chem... Consolidation i...	18 Years - 75 Years	Sun Yat-sen University
Fraction Dose Escalation of Hypo-fractionated Radiotherapy in LANSCLC	NCT04951063	Locally Advance...	Hypofractionate... Concurrent chem... Consolidation i...	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for definitive hypofractionated chemoradiotherapy