Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-02-08 @ 11:26 PM
Study NCT ID:
NCT03634202
Status:
TERMINATED
Last Update Posted:
2019-05-15
First Post:
2018-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Radiation Therapy in Combination With Xeloda, for Initially Metastatic, Low and Middle Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Phase-1 study of escalade dose of radiation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'the study was stopped for lack of inclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-13', 'studyFirstSubmitDate': '2018-08-06', 'studyFirstSubmitQcDate': '2018-08-14', 'lastUpdatePostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum tolerated radiation dose (MTD) delivered by IMRT with SIB, in combination with oral capecitabine, for initially metastatic, low and middle rectal cancer after 4 induction cycles of mFolfox6 regimen.', 'timeFrame': '84 months', 'description': 'MTD = dose level -1 after at least 2 patients with DLT to upper level'}], 'secondaryOutcomes': [{'measure': 'Local Progression-free survival at 12 months,', 'timeFrame': '12 months after inclusion', 'description': '% patient with Local Progression at CT scan, 12 months after inclusion'}, {'measure': 'Toxicity profile of the chemoradiation step for NCI.CTC grade 3-4 local toxicities due to "Pelvic Radiation Disease"', 'timeFrame': '84 months', 'description': '% patient with \\>= grade 3 toxicity (NCI.CTC AE)'}, {'measure': 'To evaluate quality of Life', 'timeFrame': '84 months', 'description': 'EORTC-QLQC-30'}, {'measure': 'To evaluate quality of Life', 'timeFrame': '84 months', 'description': 'QLQ-CR29'}, {'measure': 'Overall survival at 2 years', 'timeFrame': '24 months after inclusion', 'description': 'Overall survival is defined as the delay between the date of inclusion and the date of end of study'}, {'measure': 'The usefulness of surgery', 'timeFrame': '12 months after the end of radiochemotherapy', 'description': 'The surgical decision within 12 months after the end of radiochemotherapy will be recovered'}, {'measure': 'The prognostic value of PET', 'timeFrame': '108 months', 'description': 'The interest of PET to define the volume in radiotherapy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensity Modulated Radiotherapy', 'Simultaneous Integrated Boost', 'Low and middle Rectal carcinoma'], 'conditions': ['Rectal Cancer', 'Metastasis', 'Radiotherapy']}, 'descriptionModule': {'briefSummary': 'In initially metastatic rectal carcinoma, a neo-adjuvant multi-drug chemotherapy is usually performed, followed by a pelvic chemoradiation. The surgical indications on both metastases and the pelvic site are then discussed: in the case where a complete (or near-complete) response (CR) of the rectal tumor is observed (10 to 40%), the local surgery may be omitted or poned ("wait-and-see") in a sphincter-sparing strategy, in order to minimize or avoid the surgical morbidity, to focus on metastatic disease by the continuation of chemotherapy, and to preserve a better quality of life. After 8 weeks of induction chemotherapy (mFolfox6 regimen, 4 cycles), the aim of our study is to optimize the chemoradiation step on the distal rectal tumor, thanks to Intensity-Modulated Radiotherapy (IMRT) with simultaneous integrated boost (SIB) (Phase-1 part of the study), concomitantly with oral capecitabine. According to a Fibonacci dose-escalation scheme, 3 radiation dose-levels are defined, up to the definition of the maximal tolerated dose (MTD), requiring the inclusion of a maximum of 20 patients. Further patients will be included at the recommended dose for phase-2 (RDP2) in a two-step phase-2 study, considering simultaneously as principal objective at 12 months, both the efficacy (local CR rate in the range of 10 to 25%) and the tolerance (pelvic radiation disease: grade 3-4 toxicities in the range of 30 to 10%). Overall 65 patients will be included in the phase-2 study at the RDP2 dose.', 'detailedDescription': 'The study population has metastatic rectal cancer. After obtaining informed consent and if they fulfil all of the criteria for inclusion, patients will be included.\n\nAfter 8 weeks of induction chemotherapy with FOLFOX, patients perform an imaging assessment.\n\nThen they are treated by radiotherapy with an oral Xeloda At the end of irradiation, patients realize on other Imaging assessment. Patients are then followed for 2 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Metastatic distal rectal carcinoma (low and middle);\n2. age \\>18 years\n3. Estimated life expectancy greater than 3 months\n4. PS: ECOG\\<2\n5. Normal hematologic, renal and hepatic functions\n6. Normal or only partially decreased DPD activity\n7. Effective contraception in women and men of childbearing age\n8. Social insurance.\n9. Signed informed consent\n\nExclusion Criteria:\n\n1. No previous treatment with pelvic radiotherapy or chemotherapy\n2. Disorder precluding understanding of trial information or informed consent\n3. No severe or uncontrolled disease (infection, VIH, HBs, diabetes mellitus)\n4. No peripheral neuropathy \\> grade 2\n5. No inflammatory disease or fructosemia\n6. Diarrhea of grade \\> 2\n7. Pregnancy, breastfeeding women\n8. Patients already included in another therapeutic within a period of 30 days\n9. Other malignancy treated within the last 5 years (except non-melanoma skin cancer)\n10. Bilateral total hip prosthesis\n11. Patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations'}, 'identificationModule': {'nctId': 'NCT03634202', 'acronym': 'DESIR', 'briefTitle': 'Study of Radiation Therapy in Combination With Xeloda, for Initially Metastatic, Low and Middle Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Phase-1 Study of Escalated-dose Pelvic Radiation Therapy Using Intensity-Modulated Radiotherapy (IMRT) With Simultaneous Integrated Boost (SIB), in Combination With Xeloda, for Initially Metastatic, Low and Middle Rectal Cancer', 'orgStudyIdInfo': {'id': 'ICO-A-2013-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMRT + oral chemotherapy', 'description': 'Radiotherapy = IMRT with SIB. The overall duration of irradiation is 5 to 7 weeks Chemotherapy = oral capecitabine. Chemotherapy is taken in concomitance as radiotherapy days', 'interventionNames': ['Combination Product: IMRT + oral chemotherapy']}], 'interventions': [{'name': 'IMRT + oral chemotherapy', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Intensity-Modulated Radiotherapy + capecitabine'], 'description': "It's a dose escalation of radiation (IMRT), during 5 to 7 weeks, 5 days per week.\n\nConcomitantly, patient have oral chemotherapy (capecitabin)", 'armGroupLabels': ['IMRT + oral chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'AMAURY PAUMIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut de Cancérologie de l'Ouest"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}