Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Neoplasms, Second Primary

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases

The regular fraction modes were as follows: a. lesions≥3 cm：52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions\<2cm：36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm：40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem：50-60Gy/2.5-3Gy/20f.

Fractionated Stereotactic Radiotherapy

concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/m2\*5d, q28d, 6cycles

Jianping Xiao

This clinical trial was designed to investigate the efficiency and toxicity of fractionated stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain metastases.

This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of FSRT plus TMZ for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.

Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases

Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Refractory Brain Metastases: A Single-arm, Single-center Phase II Trial

defined as no progress of the treated lesions and no distant progress in the brain

Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD

assessed by CTCAE criteria, v4.0 and RTOG criteria of the central nervous system

collect the data of causes of death and analyze

Cancer Foundation, China

Chinese Academy of Medical Sciences

Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases.

Intervention：tomotherapy

Tomotherapy: The regular fraction modes were as follows: a. lesions≥3 cm:52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions\<2cm:36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm: 40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem:50-60Gy/2.5-3Gy/20f; 3. multiple lesions with large lesion: whole brain radiation (WBRT) with 40Gy/2Gy/20f and concurrent boost of 60Gy/3Gy/20f of the lesions.

TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2\*5d, q28d, up to 6cycles.

tomotherapy

This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for refractory brain metastases.

This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.

Tomotherapy for Refractory Brain Metastases

Tomotherapy for Refractory Brain Metastases: a Single Arm, Single Center Phase II Trial

the baseline characteristics and treatment plan can be shared with other researchers when the research paper has been published. The IPD will be sent by email if applied.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases	NCT02654106	Brain Metastase...	Fractionated St... Temozolomide	18 Years - 75 Years	ChineseAMS
Tomotherapy for Refractory Brain Metastases	NCT03027544	Brain Metastase...	tomotherapy	18 Years - 75 Years	ChineseAMS
Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases	NCT02654106	Brain Metastase...	Fractionated St... Temozolomide	18 Years - 75 Years	ChineseAMS
Tomotherapy for Refractory Brain Metastases	NCT03027544	Brain Metastase...	tomotherapy	18 Years - 75 Years	ChineseAMS

Spots Global Cancer Trial Database for meningeal metastases