NSCLC Isotoxic Hypofractionated Chemoradiotherapy

NCT03606239 | Unknown DMC

• 1 other identifier: NSCLS isotoxic HypoRCT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Radiotherapy plays an important role in non-small cell lung cancer (NSCLC), and concurrent chemoradiation is considered to be the standard treatment for locally advanced NSCLC. However, due to the patient's physical condition, comorbidities and other reasons, only about 1/3 of patients can receive concurrent chemoradiation. Radiotherapy alone or sequential chemoradiation has become the treatment protocol for most patients. Hypofractionated radiotherapy can be used in NSCLC because it can shorten the over treatment time and may potentially reduce the effect of accelerated repopulation and obtain higher biological effective dose（BED）. So far, the vast majority of radiotherapy prescriptions have given a uniform dose of 60 Gy. This unified prescription dosage approach is completely inconsistent with the concept of precision treatment. The Netherlands MAASTRO put forward the concept of in silico radiotherapy prescription, that is: the normal tissue limits are uniform, such as: V20% ≤ 30%, spinal cord V0\> 45Gy, etc., and each patient receives a different dose of radiation therapy. This radiation prescription could reach the limits of the normal tissue of every patient; if no one tissue limits were reached, the highest dose was set up to 79.2 Gy (1.8 Gy, BID). MAASTRO applied this "iso-toxic" radiotherapy prescription and used accelerated hyperfractionation technology so that each patient received the maximum individualized radiation dose as possible. We will integrate this concept with hypofractionated radiotherapy in order to further improve efficacy.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

isotoxic; hypofractionated radiotherapy; Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• radiation induced esophagitis and radiation induced pneumonitis

  Number of participants with treatment-related severe adverse events：Grade IV radiation esophagitis, Grade III radiation esophagitis which results in interruption of radiotherapy for 7 days or more, and Grade III or above radiation pneumonitis

  2 years

Secondary Outcomes (4)

• time to disease progression (TTP)

  5 years

• progression-free survival(PFS)

  5 years

• overall survival (OS)

  5 years

• local control（LC）

  5 years

Study Arms (1)

isotoxic hypofractionated group

EXPERIMENTAL

Hypofractionated radiation: 1\. Split mode: 3Gy/f. 2,Individualized prescriptions for different patients: (1) Spinal cord: 0%\>45 Gy, and ≤2 Gy each time Lung: V20≤30%, V5≤65%, MLD≤16Gy Esophagus: highest dose ≤ 69Gy 3. Maximum limit: If the limit of any "A" is not reached, the maximum radiation dose is 69 Gy. The lowest radiation dose: 45Gy. Chemotherapy: Platinum-containing two-drug regimen: docetaxel + lobaplatin: Docetaxel 60 mg/m2, d1; Lobaplatin 30 mg/m2, d1; repeated every 28 days. The first cycle of chemotherapy started on the first day of radiotherapy. The same chemotherapy regimen is used up to 4 cycles as consolidation after the completion of radiotherapy.

Radiation: isotoxic hypofractionated group

Interventions

isotoxic hypofractionated group RADIATION

the normal tissue limits are uniform, such as: V20% ≤ 30%, spinal cord 0\> 45Gy, etc., and used hypofractionated radiotherapy technology so that each patient received the maximum individualized radiation dose as possible，and the same time use the Platinum-containing drugs: docetaxel + lobaplatin Docetaxel 60 mg/m2, d1; Lobaplatin 30 mg/m2, d1, repeated every 28 days. The first cycle of chemotherapy started on the first day of radiotherapy.Consolidate chemotherapy up to 4 cycles after radiotherapy, as above.

isotoxic hypofractionated group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological or cytological diagnosis of non-small cell lung cancer patients, the clinical stage using the eighth edition of American Joint Committee on Cancer（AJCC）, including stage III without resectable or who when SBRT/SABR are not suitable;
• Age ≥ 18 years，≤ 75 years;
• The expected survival period is ≥ 3 months;
• Karnofsky performance status （KPS） score ≥ 60;
• Normal blood account , liver and kidney function;
• Forced expiratory volume in 1 second of 0.75 L or greater.

You may not qualify if:

• Serious medical problems require hospitalization, include (but not limited to ): history of pulmonary fibrosis, previous myocardial infarction within 6 months, heart failure grade II and above, uncontrolled heart failure, uncontrolled chronic obstructive pulmonary disease （COPD）, uncontrolled diabetes .et al;
• Esophageal invasion (cT4);
• Others are not suitable for receiving radiotherapy and chemotherapy.

Sponsors & Collaborators

• The Second Hospital of Hebei Medical University: lead

Study Sites (1)

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

Related Publications (1)

• Liu YE, Xue XY, Zhang R, Chen XJ, Ding YX, Liu CX, Qin YL, Li WQ, Ren XC, Lin Q. Study protocol: a multicentre, prospective, phase II trial of isotoxic hypofractionated concurrent chemoradiotherapy for non-small cell lung cancer. BMJ Open. 2020 Oct 23;10(10):e036295. doi: 10.1136/bmjopen-2019-036295.

  PMID: 33099491 DERIVED

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 Officials

• Xiao-Ying Xue, Professor

  The Second Hospital of Hebei Medical University

  STUDY CHAIR

• Qiang Lin, Professor

  North China Petroleum Bureau General Hospital, Hebei Medical University

  STUDY DIRECTOR

• Chao-Xing Liu, Professor

  No.1 Hospital of Shijiazhuang City

  STUDY DIRECTOR

Central Study Contacts

Xiao-Ying Xue, Professor

CONTACT

+86-158-0321-0636; xxy0636@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Radiotherapy

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 30, 2018
• Study Start: February 1, 2019
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2026
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the publication of this study, we could share the IPD
• Access Criteria: However, this sharing is limited to academic research. Person to be contacted: Study Chair: Professor Xiao Ying Xue.

Locations

CN (1)