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Stereotactic Body Radiation Therapy (SBRT) in Newly Diagnosed Advanced Staged Lung Adenocarcinoma (Sindas) (Sindas)

Primary Purpose

Stage IV EGFR Mutated Non-Small Cell Lung Cancer

Status

Terminated

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Radiation: SBRT

TKI (Gefitinib or Tarceva )

About this trial

This is an interventional treatment trial for Stage IV EGFR Mutated Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Newly diagnosed metastatic lung adenocarcinoma (recurrent or de novo) harboring sensitizing EGFR mutations (L858R, exon 19 deletion, G719A, L861Q, S768I, exon 19 insertions) with oligometastatic disease (≤5 discrete lesions of disease irrespective of location, inclusive of the primary lesion):
- all sites of disease must be amenable to definitive treatment with a local therapy (surgical resection, stereotactic radiosurgery, ablation and conventional radiation therapy) as determined by surgery, interventional radiology and radiation oncology
- all intrathoracic lymph nodes (including hilar, mediastinal, and supraclavicular nodal disease) are considered 1 discrete lesion.
No brain metastasis is allowed.
Patients already started on erlotinib are eligible as long as their sites of disease are determined to be eligible for definitive local therapy by consensus of the principal investigators within 12 weeks of the patient first taking erlotinib.
Lung adenocarcinoma histology confirmed
Karnofsky Performance Status ≥ 70%
Adequate bone marrow, liver and renal function, as specified below:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- Hemoglobin ≥ 8 g/dL
- Platelets ≥ 100 x 109/L
- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's Syndrome)
- AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present
- Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal.
For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter

Exclusion Criteria:

Treatment with TKI prior to developing metastatic disease
Malignant pleural effusion or pleural disease
Leptomeningeal disease or brain metastasis.
Any site of disease that is not amenable to definitively local therapy including surgery or radiation therapy
Women who are breastfeeding or pregnant
Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment.
Any medical co-morbidities that would preclude surgery or radiation therapy

Sites / Locations

Sichuan PPH, Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TKI without SBRT

TKI with SBRT

Arm Description

Newly diagnosed Patients will be placed on EGFR-TKI, ,Gefitinib 250mg po qd or Tarceva 150mg po qd for their metastatic EGFR-mutant stage IV oligometastatic disease. The oligometastatic disease will not receive SBRT

experimental: Oligometastatic Non-Small Cell Lung Cancer Newly diagnosed patients will be placed on EGFR-TKI, Gefitinib 250mg po qd or Tarceva 150mg po qd, for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will TKI, Gefitinib 250mg po qd or Tarceva 150mg po qd, and SBRT at the same time. SBRT to up to 5 sites. The SBRT dose range from 5 Gy per fraction to 8 Gy per fraction. SBRT deliver within 5 fractions.

Outcomes

Primary Outcome Measures

Progression free survival

Evaluate the effect of TKI with or without SBRT on progression free survival,to describe local control and out-of-field disease progression

Secondary Outcome Measures

Overall survival

To evaluate overall survival after SBRT followed by maintenance chemotherapy in comparison to maintenance chemotherapy alone.

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

Using CTCAE system to evaluate toxicity profile

Full Information

NCT ID

NCT02893332

First Posted

August 24, 2016

Last Updated

January 29, 2021

Sponsor

Sichuan Provincial People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02893332

Brief Title

Stereotactic Body Radiation Therapy (SBRT) in Newly Diagnosed Advanced Staged Lung Adenocarcinoma (Sindas)

Acronym

Sindas

Official Title

Tyrosine-kinase Inhibitor （TKI） With or Without SBRT in Newly Diagnosed EGFRm Advanced Staged Lung Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Terminated

Why Stopped

After interim analysis, IRB recommend termination.

Study Start Date

January 15, 2016 (Actual)

Primary Completion Date

August 30, 2020 (Actual)

Study Completion Date

August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sichuan Provincial People's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To tested if the adding of consolidative SBRT to TKI in EGFR mutated patients with less than or equal to 5 metastatic sites (primary + 5) will improve progression free survival (PFS) compared to TKI alone.

Detailed Description

This protocol is a randomized phase III trial of TKI versus consolidative Stereotactic Body Radiation Therapy (SBRT) plus TKI for patients with Stage IV non-small cell lung cancer (NSCLC). Prior to accrual on the trial, patients with Stage IV NSCLC will be tested with positive EGFR mutation. Patients who with fewer than or equal to 5 sites of oligometastatic disease will be randomized toTKI or consolidative SBRT to all sites of disease (followed by TKI at the medical oncologist's discretion). Choices of TKI will be determined by the medical oncologist based on clinical appropriateness.

6. Conditions and Keywords

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

Stage IV EGFR Mutated Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TKI without SBRT

Arm Type

Active Comparator

Arm Description

Arm Title

TKI with SBRT

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Radiation: SBRT

Intervention Description

A first line TKI (Gefitinib 250mg po qd or Tarceva 150mg po qd ) will be administered according to the standard dosing of the drug for metastatic NSCL during a 1-week run-in period after which SBRT will be delivered to the all oligometastatic lesions concurrently with the TKI. The SBRT dose will be , ranging from at 25Gy (5 Gy per fraction) to 40 Gy (8 Gy per fraction).

Intervention Type

Drug

Intervention Name(s)

TKI (Gefitinib or Tarceva )

Intervention Description

A first line TKI (Gefitinib 250mg po qd or Tarceva 150mg po qd ) will be administered according to the standard dosing of the drug for metastatic NSCL, no local therapy apply to oligo-metastatic sites.

Primary Outcome Measure Information:

Title

Progression free survival

Description

Evaluate the effect of TKI with or without SBRT on progression free survival,to describe local control and out-of-field disease progression

Time Frame

4 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

To evaluate overall survival after SBRT followed by maintenance chemotherapy in comparison to maintenance chemotherapy alone.

Time Frame

4 years

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

Description

Using CTCAE system to evaluate toxicity profile

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Newly diagnosed metastatic lung adenocarcinoma (recurrent or de novo) harboring sensitizing EGFR mutations (L858R, exon 19 deletion, G719A, L861Q, S768I, exon 19 insertions) with oligometastatic disease (≤5 discrete lesions of disease irrespective of location, inclusive of the primary lesion): all sites of disease must be amenable to definitive treatment with a local therapy (surgical resection, stereotactic radiosurgery, ablation and conventional radiation therapy) as determined by surgery, interventional radiology and radiation oncology all intrathoracic lymph nodes (including hilar, mediastinal, and supraclavicular nodal disease) are considered 1 discrete lesion. No brain metastasis is allowed. Patients already started on erlotinib are eligible as long as their sites of disease are determined to be eligible for definitive local therapy by consensus of the principal investigators within 12 weeks of the patient first taking erlotinib. Lung adenocarcinoma histology confirmed Karnofsky Performance Status ≥ 70% Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L Hemoglobin ≥ 8 g/dL Platelets ≥ 100 x 109/L Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's Syndrome) AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal. For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter Exclusion Criteria: Treatment with TKI prior to developing metastatic disease Malignant pleural effusion or pleural disease Leptomeningeal disease or brain metastasis. Any site of disease that is not amenable to definitively local therapy including surgery or radiation therapy Women who are breastfeeding or pregnant Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment. Any medical co-morbidities that would preclude surgery or radiation therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Zeng, MD PhD

Organizational Affiliation

Sichuan Provincial People Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Sichuan PPH, Cancer Center

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

710062

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Stereotactic Body Radiation Therapy (SBRT) in Newly Diagnosed Advanced Staged Lung Adenocarcinoma (Sindas)

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