Fraction Dose Escalation of Split-course Adaptive Hypo-fractionated Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This prospective phase I study intends to explore the maximum tolerable single radiation dose for locally advanced non-small cell lung cancer patients undergoing radical concurrent radiochemotherapy at the same bioequivalent radiation dose

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

Inclusion Criteria:

• Non-small cell lung cancer confirmed by histology.

• Tumor size is measured according to RECIST standard.

• Unresectable stage IIIA (N2) and IIIB/IIIC, confirmed by PET-CT/or chest and abdomen CT, brain MRI, and whole body bone scan.

• 18-75 years old, regardless of gender.

• The ECOG score is 0-1.

• Newly treated or underwent neoadjuvant chemotherapy and/or immunotherapy.

• Have not received chest radiotherapy in the past.

• Serum hemoglobin ≥10 mg/dL, platelets ≥100000/μL, absolute neutrophil count ≥1500/μL.

• Serum creatinine ≤1.25 times UNL or creatinine clearance ≥60 ml/min.

• Serum bilirubin ≤1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤2.5 times UNL, alkaline phosphatase≤ 5 times UNL.

• FEV1>1 L.

• CB6 normal range.

• The patient and his family members agree and sign an informed consent form.

Exclusion Criteria:

• Other malignant tumors in the past or during treatment, except for non-melanoma of the skin or carcinoma in situ of the cervix.

• Any other diseases or conditions are contraindications to chemotherapy (such as active infection, within 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy).

• Pregnant or breastfeeding women, women who have not undergone a pregnancy test (within 14 days before the first dose), and pregnant women.

• Those who are pregnant, breastfeeding or have fertility but have not taken contraceptive measures.

• People with bleeding tendency.

• Those who participated in other clinical trials within 30 days before participating in this experiment.

• Drug addiction, long-term alcoholism, and AIDS patients.

• People with uncontrollable seizures or loss of self-control due to mental illness.

• People with a history of severe allergies or specific physique.

• The researcher believes that the patient is inappropriate to participate in this trial.

Exit criteria

• The treatment cannot be carried out in accordance with the requirements of the research protocol;

• The patient has an allergic reaction ≥ grade 4 or a serious adverse reaction to the study drug;

• The patient is pregnant or has not used adequate contraceptive measures;

• The researcher judges that the patient should not continue to participate the clinical trial;

• The subject asked to withdraw.