NCT07835789Toborzás még nem indult2. fázis
Testing Repeat Radiation Therapy for Recurrent Non-small Cell Lung Cancer
A Phase II Randomized Study of Reirradiation for Locally Recurrent Non-Small Cell Lung Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 23.
Rövid összefoglaló (regiszter, angolul)
This phase II trial compares repeat radiation therapy (RT) to standard drug treatment alone in treating patients with stage II-III non-small cell lung cancer (NSCLC) that has come back after initial radiation at or adjacent to the site of the original tumor (locally recurrent). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Chemotherapy drugs used in standard drug treatment work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy drugs used in standard drug treatment may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Targeted therapy drugs used in standard treatment identify and attack specific tumor cells. This trial may help doctors determine whether repeat RT delays the cancer from growing or spreading by 6 months or more after initial radiation compared to standard drug treatment alone in patients with stage II-III locally recurrent NSCLC.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 138 (tervezett)
- Első benyújtás
- 2026. szept. 17.
- Kezdés
- 2026. dec. 18.
- Elsődleges befejezés
- 2029. szept. 30.
- Fő szponzor
- NRG Oncology
- Betegségek
- Tüdőrák
- NCT-szám
- NCT07835789
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 138
- 2026. dec. 18. és az elsődleges befejezés (2029. szept. 30.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Kiket keres a vizsgálat
- History of stage II-III NSCLC treated with fractionated (≤ 4 Gy per fraction) curative-intent (total dose ≥ 45 Gy) thoracic radiotherapy, completed ≥ 12 months before study entry
- Participants must have recurrent/progressive disease in the lung and/or regional lymph nodes that is not suitable for treatment with stereotactic body radiation therapy (SBRT) and for which palliative thoracic radiotherapy is not required at the time of study entry
- Biopsy to confirm recurrent/progressive disease at some point after the previous course of thoracic radiotherapy and before entering this study is required
- A portion of the disease that would be treated with radiotherapy on Arm 2 of this protocol must fall within the 50% isodose cloud of the radiotherapy plan
- New systemic lung cancer therapy initiated within 12 weeks prior to study entry that is still ongoing is not permitted
- Participants must not have definitive clinical or radiographic evidence of distant metastatic NSCLC at present or in the past
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Not Pregnant and Not Nursing
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
- Prior thoracic radiotherapy for NSCLC must have been delivered as definitive treatment, as opposed to in the preoperative or postoperative setting. One prior radiotherapy course must meet the specifications, and the radiotherapy plan from that course must be available in Digital Imaging and Communications in Medicine (DICOM) format
- Patients who have received additional prior radiotherapy (i.e., more than one prior radiotherapy course) may be enrolled, provided that only one prior radiotherapy course is deemed to affect the risks associated with treatment with radiotherapy on this study. As examples, prior radiotherapy for an extrathoracic malignancy would likely not affect the risks associated with reirradiation on this study. Prior radiotherapy for breast cancer may be permissible, depending on the extent of lung irradiation. Similarly, prior SBRT for a peripheral lung tumor may be permissible
- No prior SBRT for a central lung tumor, hilar lymph node, or mediastinal lymph node
- Prior lobar and sublobar lung resections are allowed, but prior pneumonectomy is not allowed
- Prior chemotherapy, targeted therapy, and/or immunotherapy for lung cancer is allowed
- No history of CTCAE version (v.) 5.0 grade 2-4 RT pneumonitis or ongoing CTCAE v. 5.0 grade 2-4 pneumonitis from any cause
- No clinically significant interstitial lung disease
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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