Overview
Fraction Dose Escalation of Split-course Adaptive Hypo-fractionated Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung Cancer
Status:
Recruiting
Recruiting
Trial end date:
2022-08-31
2022-08-31
Target enrollment:
0
0
Participant gender:
All
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 dosePhase:
Phase 1Accepts Healthy Volunteers?
NoDetails
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.