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

Primary Purpose

Small Cell Lung Cancer Limited Stage

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Hyperfractionated radiotherapy

Hypofractionated radiotherapy

Etoposide

Cisplatin

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer Limited Stage focused on measuring radiotherapy, chemotherapy, radiation dose, radiotherapy target volume

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hyperfrationated Arm

Hypofrationated Arm

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival

OS, measured from the date of randomization to the date of death from any cause.

Full Information

NCT ID

NCT04543890

First Posted

August 23, 2020

Last Updated

September 2, 2020

Sponsor

Zhejiang Cancer Hospital

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Chinese PLA General Hospital, Guangdong Medical College

1. Study Identification

Unique Protocol Identification Number

NCT04543890

Brief Title

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

Acronym

CTV

Official Title

A Multicenter, Prospective, Randomized Study Comparing Hypofractionated Radiotherapy With Hyperfractionated Radiotherapy Combined With Concurrent Chemotherapy and Omitting Clinical Target Volumes of the Primary Tumor in Limited-stage SCLC

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

June 1, 2023 (Anticipated)

Study Completion Date

June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Cancer Hospital

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Chinese PLA General Hospital, Guangdong Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer Limited Stage

Keywords

radiotherapy, chemotherapy, radiation dose, radiotherapy target volume

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hyperfrationated Arm

Arm Type

Active Comparator

Arm Description

Arm Title

Hypofrationated Arm

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Hyperfractionated radiotherapy

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Hypofractionated radiotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Etoposide

Other Intervention Name(s)

VP-16

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

DDP

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free survival

Description

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.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

OS, measured from the date of randomization to the date of death from any cause.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Chen, MD, PhD

Phone

+86-571-88122199

chenming@zjcc.org.cn

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming Chen, MD, PhD

Phone

+86-571-88122199

chenming@zjcc.org.cn

12. IPD Sharing Statement

Learn more about this trial

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

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