Hypofraction Radiotherapy for Limited-Stage Small Cell Lung Cancer

NCT05523908 | Completed

• 1 other identifier: 2022ky454
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Concurrent chemoradiotherapy is the standard modality for locally advanced small-cell lung cancer, which could achieve median overall survival of 25 mos. Conventional fractionation of 66Gy/33f and hyperfractionation of 45Gy/30f twice daily have been acknowledged as the two standard radiotherapy modalities according to CONVERT study. In 2021, a phase II trial demonstrated that 60Gy/40f twice daily was superior to the standard 45Gy/30f twice daily in light of overall survival (2y OS 74.2% vs. 39% p=0.0005), which to some extent implied that higher dose may confer better survival. Hypofractionated radiotherapy was another useful modality to increase biological effective dose with the advantage of short course and convenience. The effectiveness and safety of 60Gy/15f has been demonstrated in the treatment of locally advanced non-small cell lung cancer. Therefore, this trial is designed to explore the safety and primary efficacy of hypofraction radiotherapy for stage III locally advanced small cell lung cancer.

Conditions

Safety Issues; Efficacy, Self

Keywords

Hypofraction RT, Limited-Stage SCLC

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 (1)

• 2 year locoregional control rate (RECIST 1.1)

  2 year

Other Outcomes (2)

• 2 year progression-free rate (RECIST 1.1)

  2 year

• 2 year overall survival rate (RECIST 1.1)

  2 year

Study Arms (2)

High-dose hypofraction Arm

EXPERIMENTAL

Patients in this arm (High-dose hypofraction Arm) would receive high-dose fractionated radiotherapy with 60Gy/15f.

Radiation: High-dose hypofraction Arm

Low-dose hypofraction Arm (Standard BED)

EXPERIMENTAL

Patients in this arm (Low-dose hypofraction Arm) would receive high-dose fractionated radiotherapy with 48Gy/12f.

Radiation: Low-dose hypofraction Arm (Standard BED)

Interventions

High-dose hypofraction Arm RADIATION

Patients in this arm would receive high-dose fractionated radiotherapy with 60Gy/15f

High-dose hypofraction Arm

Low-dose hypofraction Arm (Standard BED) RADIATION

Patients in this arm would receive low-dose fractionated radiotherapy with 48Gy/12f

Low-dose hypofraction Arm (Standard BED)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• ECOG 0-1;
• Small cell lung cancer;
• Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonagraph, bone scan or cranial MRI and PET-CT;
• Signature of inform consent.

You may not qualify if:

• Younger than 18 years old or older than 75 years old;
• ECOG\>1;
• Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma;
• Extensive stage confirmed by cranial MRI, chest CT, abdominal ultrasonagraph, bone scan or cranial MRI and PET-CT;
• No signature of inform consent.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui Provicial Hospital

Hefei, Anhui, China

Location

Related Publications (1)

• Li XY, Yan B, Zhang JQ, Li Y, Xia DQ, Xie W, He Y, Wang JG, Ma J, Cao LJ, Qian D. Short-course hypofractionated radiotherapy of 4 Gy per fraction for limited-stage small cell lung cancer: a randomized pilot trial. Transl Lung Cancer Res. 2025 Aug 31;14(8):2996-3008. doi: 10.21037/tlcr-2025-281. Epub 2025 Aug 26.

  PMID: 40948832 DERIVED

Study Officials

• Dong P Qian, M.D.

  The First Affiliated Hospital of USTC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 1, 2022
• Study Start: February 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 1, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)