Hypofractionated Radiotherapy Combined with Immunotherapy for Limited-stage Small-cell Lung Cancer: a Phase II Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Concurrent chemoradiotherapy has long been 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. With the introduction of immune checkpoint inhibitors, ADRIATIC study concluded that consolidative Durvalumab after concurrent chemoradiotherapy could achieve a far longer median overall survival of 55.9 months compared with 33.4 months for concurrent chemoradiotherapy. Recently, several studies have demonstrated the safety and efficacy of hypofractionated radiotherapy (3 to 4 Gy) for limited-stage small-cell lung cancer. Hypofractionated radiotherapy processes the advantage of short treatment duration compared with conventional fractionated radiotherapy, which may allow the early participation of immunotherapy. Therefore, we suppose that whether hypofractionated radiotherapy combined with immunotherapy could improve the survival of limited-stage of small-cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 18-70 years old;

• ECOG 0-1;

• Adequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy;

• Small-cell lung cancer;

• Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT;

• Signature of inform consent.

Locations
Other Locations
China
Anhui Provicial Hospital
RECRUITING
Hefei
Contact Information
Primary
Dong Qian, M.D.
qiandong@ustc.edu.cn
+8619156007756
Backup
Xiao-Yang Li
drxyl@ustc.edu.cn
+8618701851829
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 45
Related Therapeutic Areas
Sponsors
Leads: Anhui Provincial Hospital

This content was sourced from clinicaltrials.gov