Small-cell Lung CancerPhase 3SHARPNCT06457906
SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC
A Phase 3 study testing Experimental group (SRS/SRT/Hypo-RT) in people with Small-cell Lung Cancer and Brain Metastases, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This phase III trial compares the effect of stereotactic radiosurgery and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Small-cell Lung Cancer, Brain Metastases, SRS
- What is being tested?
- Experimental group (SRS/SRT/Hypo-RT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 28 Feb 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Investigators should consider these factors when selecting patients for this trial. Investigators also should consider all other relevant factors (medical and non-medical), as well as the risks and benefits of the study therapy, when deciding if a patient is an appropriate candidate for this trial.
- Adult patients (18-80 years of age) with Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance score ≥ 70, expected life time more than 6 months;
- Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic or brain metastasis). Patients with de novo or recurrent small cell lung cancer are permitted;
- No more than 10 metastatic brain lesions with ≤5 cm in largest diameter and ≤150 ml in treated volume, confirmed by a high-resolution (thickness ≤2mm) , 3-dimensional T1-weighted postgadolinium magnetic resonance imaging (MRI) brain scan within 2 weeks of study initiation. All brain metastases must be outside a 5-mm margin around either hippocampus or optic pathways.
- Not all metastatic brain lesions are recommended or suitable for surgical resection after multidisciplinary team discussion. If part of metastatic brain lesions are resected, the patient is permitted for enrollment evaluation at least two weeks after resection; 5 Patients must have the psychological ability and general health that permits completion of the study requirements, all assessment (HVLT-R, MoCA, EORTC QLQ-C30) and required follow up (at least 6 months);
- 6. At least one measurable BM according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria; 7. Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception during treatment on this study and for up to 180 days after completion of all treatment to prevent pregnancy or fathering a child; 8. Written informed consent (must be available before enrolment in the trial).
Who cannot join
- Clinical or radiologic evidence of new, untreated, and/or progressive brain metastases prior to registration;
- Previous radiotherapy of the brain;
- Patients can not tolerate immobilization or are with MRI contraindication (i.e., cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants);
- Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, leptomeningeal metastases, increased intracranial pressure requiring immediate depression surgery.
- Patients who have not yet recovered from acute high-grade (≥Grade 3) toxicities of prior therapies according Common Terminology Criteria for Adverse EventsVersion5.0 (CTC 5.0);
- Presence of other serious illnesses such as acute myocardial infarction, severe arrhythmia, or psychiatric disorders within the past 6 months;
Show all 9Show fewer
- Known carcinoma < 5 years ago (excluding carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy;
- Pregnant or lactating women;
- Participation in another clinical study or observation period of competing trials, respectively;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nan Bi
Beijing, Beijing Municipality, 100021
Jianyang Wang, M.D, +86-10-87788876, pkucell@163.com
About this study
Official title: SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in Patients With Small-Cell Lung Cancer: A Prospective, Randomized, Multicenter Phase III Trial (SHARP Trial)
This phase III trial compares the effect of stereotactic radiosurgery and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain.
Read the detailed description
Small cell lung cancer (SCLC) is the most aggressive histologic subtype of lung cancer, with a predilection for early metastases. Brain metastases (BM) are a significant threat to quality of life in patients with SCLC. Stereotactic radiosurgery (SRS)/ Stereotactic Radiotherapy (SRT) is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to the surrounding normal tissue. Thus SRS/SRT has now emerged as the preferred treatment modality, either alone or in combination with other modalities for BM. However, given the propensity for dissemination of SCLC, SRS/SRT does not appear to be a rational approach to this pathology. Recently, in selected patients, whole brain radiotherapy (WBRT) has been omitted from the initial management for BM with the aim of reducing the potential risk of delayed neurological toxicity[1-3]. Thus, the role of upfront focal treatment by means of SRS for BM from SCLC has yet to be determined
This phase III trial compares the effect of upfront local treatment (including SRS/SRT and hypofractionated radiotherapy [Hypo-RT]) and WBRT that avoids the hippocampus (the memory zone of the brain) for the treatment of no more than 10 BM in SCLC patients. The expectation is that SRS/SRT/Hypo-RT will be one of standard upfront local treatments in SCLC patients with no more than 10 BM.
Eligible patients will be 1:1 randomized to receive ether local treatment (SRS/SRT/Hypo-RT), or hippocampal-voidance WBRT. The prescription dose of SRS/SRT is 18-22Gy in 1 fraction, 27Gy in 3 fractions and 30Gy in 5 fractions. The prescription dose of Hypo-RT is 40Gy in 8 fraction. The prescription dose of HA-WBRT is 30Gy in 10 fraction. The prescription dose could be adjusted if lesions are located in brain stem when treat with SRS/SRT/Hypo-RT.
- Conditions
- Small-cell Lung Cancer, Brain Metastases, SRS, Stereotactic Radiotherapy, Whole Brain Radiotherpay, Hippocampal-avoidance
- Being tested
- Experimental group (SRS/SRT/Hypo-RT), Controled group (HA-WBRT)
- Keywords
- Small-cell Lung Cancer, Brain Metastases, SRS, Stereotactic radiotherapy, Whole brain radiotherpay, Hypofractionaed radiotherapy, Hippocampal-avoidance
- Medical subject headings
- Small Cell Lung Carcinoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group (SRS/SRT/Hypo-RT)Combination product
The prescription dose of SRS/SRT is 18-22Gy in 1 fraction, 27Gy in 3 fractions and 30Gy in 5 fractions. The prescription dose of Hypo-RT is 40Gy in 8 fraction. The prescription dose could be adjusted if lesions are located in brain stem when treat with SRS/SRT/Hypo-RT.
Controled group (HA-WBRT)Radiation
The prescription dose of HA-WBRT is 30Gy in 10 fraction.
| Study group | Role | What they receive |
|---|---|---|
| SRS/SRT/Hypo-RT group | Experimental | The patients in this group will receive local treatment for BM. Receives: Combination Product: Experimental group (SRS/SRT/Hypo-RT) |
| HA-WBRT group | Active comparator | The patients in this group will receive HA-WBRT. Receives: Radiation: Controled group (HA-WBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function scores
Hopkins Verbal Learning Test-Revised (HVLT-R) total recall score at 6 months after radiotherapy
Measured: At 6 months after radiotherapy.
Meadian OS time
The time that half of enrolled patients died.
Measured: Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy
Secondary outcomes (6)
Cognitive function scores
The Montreal cognitive assessment (MoCA) score at 3 ,6,9,12 months after radiotherapy
Measured: Measured at months 3, 6, 9, 12months after radiotherapy
Scores of quality of life
The European organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) score at 3,6,9,12 months after radiotherapy
Measured: Measured at months 3, 6, 9, 12months after radiotherapy
The time of neurological progression free survival
The time that ≥3 points reduced of HVLT-R total recall score or MoCA score after radiotherapy
Measured: Measured at months 3, 6, 9, 12months after radiotherapy
The time of intracranial overall progression free survival
The time that half of enrolled patients had intracranial relapse
Measured: Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy
The time of overall progression free survival
The time that half of enrolled patients had relapse
Measured: Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy
The rate and grade of treatment related toxicity
All adverse events of enrolled patients after radiotherapy evaluated by CTCAE 5.0
Measured: Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Sep 2023
- Primary completion30 Aug 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bi Nan, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457906
- Sponsor's protocol ID
- NCC3982
- Acronym
- SHARP
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yomo S, Hayashi M. Upfront stereotactic radiosurgery in patients with brain metastases from small cell lung cancer: retrospective analysis of 41 patients. Radiat Oncol. 2014 Jul 8;9:152. doi: 10.1186/1748-717X-9-152.
PubMed 25005424Rusthoven CG, Yamamoto M, Bernhardt D, Smith DE, Gao D, Serizawa T, Yomo S, Aiyama H, Higuchi Y, Shuto T, Akabane A, Sato Y, Niranjan A, Faramand AM, Lunsford LD, McInerney J, Tuanquin LC, Zacharia BE, Chiang V, Singh C, Yu JB, Braunstein S, Mathieu D, Touchette CJ, Lee CC, Yang HC, Aizer AA, Cagney DN, Chan MD, Kondziolka D, Bernstein K, Silverman JS, Grills IS, Siddiqui ZA, Yuan JC, Sheehan JP, Cordeiro D, Nosaki K, Seto T, Deibert CP, Verma V, Day S, Halasz LM, Warnick RE, Trifiletti DM, Palmer JD, Attia A, Li B, Cifarelli CP, Brown PD, Vargo JA, Combs SE, Kessel KA, Rieken S, Patel S, Guckenberger M, Andratschke N, Kavanagh BD, Robin TP. Evaluation of First-line Radiosurgery vs Whole-Brain Radiotherapy for Small Cell Lung Cancer Brain Metastases: The FIRE-SCLC Cohort Study. JAMA Oncol. 2020 Jul 1;6(7):1028-1037. doi: 10.1001/jamaoncol.2020.1271.
PubMed 32496550Robin TP, Jones BL, Amini A, Koshy M, Gaspar LE, Liu AK, Nath SK, Kavanagh BD, Camidge DR, Rusthoven CG. Radiosurgery alone is associated with favorable outcomes for brain metastases from small-cell lung cancer. Lung Cancer. 2018 Jun;120:88-90. doi: 10.1016/j.lungcan.2018.03.027. Epub 2018 Apr 2.
PubMed 29748022