KCT0009061
Recruiting
未知
Prospective phase II study of tailored RadioTherapy according to the response after NeoAdjuvant Chemotherapy followed by surgery in patients with lymph node metastasis in axillary level II-III and/or internal mammary and/or supraclavicular lymph node at diagnosis.
ational Cancer Center0 sites424 target enrollmentTBD
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- ational Cancer Center
- Enrollment
- 424
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Women aged 20\-70
- •2\. Patient must have pathologically diagnosed as invasive breast cancer
- •3\. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •4\. Patient must have clinically T1\-4 breast cancer (before standard neoadjuvant chemotherapy±targeted therapy)
- •5\. Patient must have lymph node metastasis in axillary level II\-III and/or internal mammary and/or supraclavicular lymph node confirmed by fine needle aspirate(FNA) or imaging study (before standard neoadjuvant chemotherapy±targeted therapy)
- •6\. Patient who have undergone breast conserving surgery or total mastectomy
- •7\. Patient who have undergone sentinel lymph node biopsy, axillary lymph node sampling, or axillary lymph node dissection
- •8\. Patients with hormone receptors, HER\-2, Ki\-67 index test results (HER\-2 2\+ cases require FISH or SISH)
Exclusion Criteria
- •1\. In the case of distant metastasis (before standard neoadjuvant chemotherapy±targeted therapy)
- •2\. Bilateral breast cancer patients
- •3\. Male breast cancer patients
- •4\. Patient with a history of radiation therapy to the ipsilateral breast or supraclavicular area in the past
- •5\. Patient diagnosed with another cancer within 5years from the start date of radiation therapy(except for thyroid cancer, in situ cervical cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin)
- •6\. If pregnant or breastfeeding
- •7\. If standard neoadjuvant chemotherapy±targeted therapy has not been completed as planned
- •8\. If there is no level II\-III axillary lymph node involvement or supraclavicular lymph node metastasis, and only internal mammary lymph node metastasis is present at the time of diagnosis
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A randomised Phase II/III trial to study radiotherapy dose escalation in patients with oesophageal cancer treated with definitive chemo-radiation with an embedded Phase II trial for patients with a poor early response using positron emission tomography (PET)on operable oesophageal cancer patientsMedDRA version: 19.1Level: LLTClassification code 10030151Term: Oesophageal cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2015-001740-11-GBVelindre NHS Trust
Active, not recruiting
Not Applicable
The SCOPE 2 Trial: Study of chemoradiotherapy in oesophageal cancer including PET response and dose escalatioISRCTN97125464Velindre NHS Trust439
Not yet recruiting
Phase 2
Phase II study: Response adapted radiation therapy after induction chemotherapy in stage II-IVA nasopharyngeal carcinomaDue to the reports of radiation dose reduction in clinical response to induction chemotherapy of NPC patients are scarce. Therefore,We propose a phase II study to evaluate efficacy and feasibility ofnasopharyngeal carcinoma ,induction chemotherapy ,EBV DNA viral loadTCTR20180831004one138
Active, not recruiting
Not Applicable
ESTUDIO FASE II CON RADIOTERAPIA (RT) CONVENCIONAL + CETUXIMAB PARA EVALUAR LA SUPERVIVENCIA ESPECÍFICA LIBRE DE LARINGECTOMIA TOTAL EN PACIENTES AFECTOS DE UN CARCINOMA ESCAMOSO DE LARINGE LOCALMENTE AVANZADO RESECABLE, ESTADIOS III O IVA, EN RESPUESTA TRAS TRATAMIENTO CON QUIMIOTERAPIA DE INDUCCIÓN TIPO TPF.CARCINOMA ESCAMOSO DE LARINGE LOCALMENTE AVANZADO RESECABLEMedDRA version: 9.1Level: LLTClassification code 10007473Term: Carcinoma squamousEUCTR2008-000332-40-ESGRUPO ESPAÑOL DE TRATAMIENTO DE TUMORES DE CABEZA Y CUELLO (TTCC)
Active, not recruiting
Phase 1
A study to investigate the effect of addition of metformin to standard treatment in patients with inoperable stage III non-small cell lung cancer.EUCTR2017-004877-15-BEAntwerp University Hospital, Department Thoracic Oncology104