| Titre |
The Role of Multimodality Management in Risk-Stratified Patients With Lung-Limited Metastatic Colorectal Cancer |
| Protocole ID |
CT0078A |
| ClinicalTrials.gov ID |
NCT03599752 |
| Type(s) de cancer |
Côlon et rectum |
| Phase |
Phase II |
| Stade |
Métastatique |
| Type étude |
Traitement |
| Médicament |
Chimiothérapie et métastasectomie pulmonaire |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Moishe Liberman
|
| Coordonnateur(trice) |
Adeline Jouquan
514-890-8000 poste 26214
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- Histological confirmation of colorectal adenocarcinoma
- Metastatic colorectal cancer involving the lung classified as determined by the treating clinical team
- Diagnosis of colorectal metastasis to lung made either histologically with trans-thoracic needle biopsy or clinically based on radiographic imaging
- Identification as a medically appropriate candidate for surgical resection of the lung metastasis (metastases) according to the evaluating cardiothoracic surgeon. Standard justification for deeming a patient medically operable based on:
- Pulmonary reserve adequate to tolerate complete resection of all intrathoracic disease, as deemed by thoracic surgeon, which may be determined by:
- Baseline forced expiratory volume in one second (FEV1) > 40% predicted
- Post-operative predicted FEV1 > 30% predicted
- Diffusion capacity of the lung for carbon monoxide (DLCO) > 40% predicted
- Absent baseline hypoxemia and/or hypercapnia
- Exercise oxygen consumption > 50% predicted
- Absent severe pulmonary hypertension
- Absent severe cerebral, cardiac, or peripheral vascular disease
- Absent severe chronic heart disease
- Ability to tolerate surgical resection and acceptable operative risk as deemed by thoracic surgeon based on performance status and medical comorbidities
- Identification as a medically appropriate candidate for systemic chemotherapy at the discretion of the evaluating medical oncologist
- Resection/definitive therapy of primary colorectal tumor with no suspicion of recurrence. Prior radiation to a rectal adenocarcinoma is permitted
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Ability to provide informed consent for participation
- Leukocytes >= 2,000/mcL
- Absolute neutrophil count >= 1,000/mcL
- Hemoglobin >= 9.0 gm/dL
- Platelet count >= 100,000/mcL
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN
- Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl >= 50 mL/min (if using the Cockcroft-Gault formula)
- Patients (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study
|
| Critètes d'exclusion |
- Tumor involvement at other metastatic sites (e.g., liver, distant lymph nodes) that has not been definitively treated. Prior surgical resection for metastatic disease at other (non-pulmonary) sites is permitted
- Presence of intact primary colorectal adenocarcinoma (or of an anastomotic recurrence)
- Previous radiotherapy to a lung metastasis that is still detectable radiographically
- Known dihydropyrimidine dehydrogenase (DPD) deficiency that would preclude the patient from tolerating 5- fluorouracil chemotherapy
- Prior intolerance of systemic therapies used as standard regimens in the treatment of metastatic CRC that would prohibit further receipt of systemic chemotherapy and/or biologic agents -e.g.,5-fluorouracil, oxaliplatin, irinotecan, anti-VEGF therapies (e.g., bevacizumab, ramucirumab), or anti-EGFR therapies (e.g., cetuximab, panitumumab, for patients with RAS wild-type colorectal tumors)
- Prior therapy with regorafenib or trifluridine/tipiracil (TAS-102) for metastatic/unresectable colorectal cancer
- Synchronous primary or prior malignancy in the past 5 years other than non-melanomatous skin cancer or in situ cancer
- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus
|
Groupe d'étude en oncologie du Québec