A Prospective Study Comparing Two Radiotherapy Dose/Fraction and Omitting CTVs of the Primary Tumor in Limited SCLC

NCT04543890 | Unknown Phase 2 DMC

• 1 other identifier: IRB-2018-129
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

For most of the patients with limited-stage SCLC, thoracic radiotherapy combined with chemotherapy is the standard treatment at present. However, the optimal dose / fraction of thoracic radiotherapy for limited-stage SCLC is still in controversial.This study is designed as a prospecitive randomized non-inferiority trial.

Conditions

Small Cell Lung Cancer Limited Stage

Keywords

radiotherapy; chemotherapy; radiation dose; radiotherapy target volume

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  PFS, defined as the time from the date of randomization to the first date of documented objective progression disease or of death from any cause.

  2 years

Secondary Outcomes (1)

• Overall survival

  5 years

Study Arms (2)

Hyperfrationated Arm

ACTIVE COMPARATOR

Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles, the CTVs of the tumor in lung parenchyma are omitted. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).

Radiation: Hyperfractionated radiotherapy; Drug: Etoposide; Drug: Cisplatin

Hypofrationated Arm

EXPERIMENTAL

Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/15 fractions) with concurrent EP/EC chemotherapy for 2cycles, the CTVs of the tumor in lung parenchyma are omitted. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).

Radiation: Hypofractionated radiotherapy; Drug: Etoposide; Drug: Cisplatin

Interventions

Hyperfractionated radiotherapy RADIATION

Thoracic radiotherapy (45 Gy/30 fractions) for the Hyperfractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions).

Hyperfrationated Arm

Hypofractionated radiotherapy RADIATION

Thoracic radiotherapy (45 Gy/15 fractions) for the Hypofractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions).

Hypofrationated Arm

Etoposide DRUG

Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.

Also known as: VP-16

Hyperfrationated Arm; Hypofrationated Arm

Cisplatin DRUG

Cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.

Also known as: DDP

Hyperfrationated Arm; Hypofrationated Arm

Eligibility Criteria

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

You may qualify if:

• Histologically/cytologically confirmed diagnosis of SCLC.
• Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage.
• Patients should be between 18 and 75 years old.
• ECOG performance status of 0-1 (Karnofsky performance status ≥ 80).
• With adequate cardiac, pulmonary, bone marrow, hepatic and renal function.
• With weight loss no more than 10% within 6 months before diagnosis.
• Informed consent must be signed.

You may not qualify if:

• Histology confirmed the mixed NSCLC components;
• Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.);
• Any disease or condition contraindicated by radiotherapy or chemotherapy;
• Malignant pleural effusion and pericardial effusion;
• Pregnant and lactating women;
• The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Chinese PLA General Hospital: collaborator
• Guangdong Medical College: collaborator

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Interventions

Radiation Dose Hypofractionation; Etoposide; Cisplatin

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Ming Chen, MD, PhD

CONTACT

+86-571-88122199; chenming@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: September 10, 2020
• Study Start: May 1, 2018
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2025
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

CN (1)