Personalized CAPTEM Radiopeptide Therapy of Advanced, Non-resectable Neuroendocrine Cancer
NCT ID: NCT04194125
Last Updated: 2020-11-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
25 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-02-01
Study Completion Date
2022-01-31
Brief Summary
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This is a non-randomized, phase II, open label study. The purpose of this study is to estimate Progression Free Survival (PFS) after treatment with Peptide Receptor Radionuclide Therapy (PRRT) 177Lu-DOTATOC standard dose (up to 4x7,4GBq 177Lu DOTATOC) in combination with capecitabine (CAP) and temozolomide (TEM) - CAPTEM.
Patients with advanced, non-resectable and/or progressive gastro-entero-pancreatic neuroendocrine tumors, GEP-NET, (G1, G2), in selected cases with high proliferation index (Ki-67\> 20%, usually below 55%), NETG3, with overexpression of somatostatin receptor (SSTR positive) will be enrolled in the study.
Patients with advanced, non-resectable and/or progressive gastro-entero-pancreatic neuroendocrine tumors, GEP-NET, (G1, G2), in selected cases with high proliferation index (Ki-67\> 20%, usually below 55%), NETG3, with overexpression of somatostatin receptor (SSTR positive) will be enrolled in the study.
Detailed Description
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This is a non-randomized, phase II, open label study.
The purpose of this study is to:
• estimate Progression Free Survival (PFS) after treatment with Peptide Receptor Radionuclide Therapy (PRRT) 177Lu-DOTATOC standard dose (up to 4x7,4GBq 177Lu DOTATOC) in combination with capecitabine (CAP) and temozolomide (TEM) - CAPTEM.
Patients with advanced, non-resectable and/or progressive gastro-entero-pancreatic neuroendocrine tumors, GEP-NET according to WHO 2017 classification, (histological grade G1, G2), in selected cases patients with high proliferation index (Ki-67\> 20%, usually below 55%), NETG3 - pancreatic, midgut neuroendocrine tumors and carcinoma of unknown primary (CUP). All with overexpression of somatostatin receptor (SSTR positive) based on somatostin receptor scintigraphy (SRS), will be enrolled in this study.
* evaluate the safety and tolerability of combination therapy using 177Lu-DOTATOC and CAPTEM.
* evaluate the health related quality of life (QoL) as measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-G.I.NET21 questionnaire.
* evaluate internal dosimetry, in a subset up to 20 patients, but at least 10 patients.
* explore the correlation of clinical efficacy outcomes with Somatostatin Receptor Scintigraphy (SRS) using 99mTc HYNICTOC (Tektordyt®) tumour uptake score.
* explore the correlation of clinical efficacy outcomes with the levels of some specific and non-specific biomarkers and gene transcripts analysis.
* compare the Time to Tumour Progression (TTP).
The schedule of treatment will include 4 courses; capecitabine (CAP), which will be administrated for 14 days with 8-week breaks, combined at 10th day with 177Lu-DOTATOC (PRRT - Peptide Receptor Radionuclide Therapy) in doses from 5,55GBq up to 7,4 GBq administered i.v. up to four times in every patient during whole therapy.
In selected patients, in those with only liver involvement or dominant liver bulky disease third and fourth administration of PRRT will be used intra-arterial administration (i.a.) via hepatic artery. The administered dose will be from 2.85 GBq up to 3.7GBq, up to two times per whole therapy, followed in each case of i.v. or i.a. PRRT by Temozolomide (TEM) p.o. administration, which will be given during 10-14th days in each therapy sessions.
Doses of PRRT could be modified due to clinical stage and laboratory parameters. Treatment will be discontinued in the case of a cumulative dose 29,6 GBq, corresponding to the radiation dose on the bone marrow below 2 Gy and cumulative dose on kidney below 23 Gy. In case of radiation dose on kidney above 23 Gy treatment will be interrupted.
The purpose of this study is to:
• estimate Progression Free Survival (PFS) after treatment with Peptide Receptor Radionuclide Therapy (PRRT) 177Lu-DOTATOC standard dose (up to 4x7,4GBq 177Lu DOTATOC) in combination with capecitabine (CAP) and temozolomide (TEM) - CAPTEM.
Patients with advanced, non-resectable and/or progressive gastro-entero-pancreatic neuroendocrine tumors, GEP-NET according to WHO 2017 classification, (histological grade G1, G2), in selected cases patients with high proliferation index (Ki-67\> 20%, usually below 55%), NETG3 - pancreatic, midgut neuroendocrine tumors and carcinoma of unknown primary (CUP). All with overexpression of somatostatin receptor (SSTR positive) based on somatostin receptor scintigraphy (SRS), will be enrolled in this study.
* evaluate the safety and tolerability of combination therapy using 177Lu-DOTATOC and CAPTEM.
* evaluate the health related quality of life (QoL) as measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-G.I.NET21 questionnaire.
* evaluate internal dosimetry, in a subset up to 20 patients, but at least 10 patients.
* explore the correlation of clinical efficacy outcomes with Somatostatin Receptor Scintigraphy (SRS) using 99mTc HYNICTOC (Tektordyt®) tumour uptake score.
* explore the correlation of clinical efficacy outcomes with the levels of some specific and non-specific biomarkers and gene transcripts analysis.
* compare the Time to Tumour Progression (TTP).
The schedule of treatment will include 4 courses; capecitabine (CAP), which will be administrated for 14 days with 8-week breaks, combined at 10th day with 177Lu-DOTATOC (PRRT - Peptide Receptor Radionuclide Therapy) in doses from 5,55GBq up to 7,4 GBq administered i.v. up to four times in every patient during whole therapy.
In selected patients, in those with only liver involvement or dominant liver bulky disease third and fourth administration of PRRT will be used intra-arterial administration (i.a.) via hepatic artery. The administered dose will be from 2.85 GBq up to 3.7GBq, up to two times per whole therapy, followed in each case of i.v. or i.a. PRRT by Temozolomide (TEM) p.o. administration, which will be given during 10-14th days in each therapy sessions.
Doses of PRRT could be modified due to clinical stage and laboratory parameters. Treatment will be discontinued in the case of a cumulative dose 29,6 GBq, corresponding to the radiation dose on the bone marrow below 2 Gy and cumulative dose on kidney below 23 Gy. In case of radiation dose on kidney above 23 Gy treatment will be interrupted.
Conditions
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Neuroendocrine Tumors
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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177Lu-DOTATOC combined with CAPTEM
* The therapy will include 4 courses (14 days per one) with 8-week intervals;
* 177Lu-DOTATOC in doses from 5,55GBq up to 7,4 GBq will be administered i.v. up to four times at 10th day;
* Concomitant amino acids will be given with each administration;
* Capecitabine will be administrated for 14 days (twice a day) followed by Temozolomide at 10-14th days in each therapy sessions.
Group Type
EXPERIMENTAL
177Lu-DOTATOC
Intervention Type
DRUG
Four administrations of 5,55GBq up to 7,4 GBq 177Lu-DOTATOC will be administered at 8-week intervals.
Interventions
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177Lu-DOTATOC
Four administrations of 5,55GBq up to 7,4 GBq 177Lu-DOTATOC will be administered at 8-week intervals.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Adults ≥18 years old, male or female;
* All patients with histologically proven, well/moderate-differentiated G1/2 GEP-NET (according to WHO 2017 classification), with Ki-67 ≤20%, in selected cases patients with NETG3 will be included if there will be reported well/moderate morphological appearance but Ki-67\>20% but less then Ki\<30% (pancreatic, midgut NET and cancer with unknown primary (CUP)); and there will be high expression of somatostatin receptor seen in functional imaging utilized functional imaging 99mTc HYNICTOC or 68Ga DOTATATE or 68Ga DOTATOC;
* The presence of high expression of somatostatin receptors demonstrated on Somatostatin Receptor Imaging using 99mTc HYNICTOC (SPECT) or 68Ga DOTATATE or 68Ga DOTATOC (PET) scans, et least as uptake in not involved liver, Krenning \>2;
* Non-resectable, advanced determined by an appropriately specialized surgeon or deemed not suitable for liver directed therapies where liver is the only site of disease;
* Performance status (PS) based on ECOG 0-2;
* Unresectable, advanced/metastatic progressive disease evaluated as clinical, biochemical, bad control symptoms of tumour hypersecretion or disease progression seen in imaging structural or functional;
* Parameteres of laboratory test:
1. Morphology: Hb\>10g/dl, PLT\>75x103/ml, WBC\> 2x103 /ml with ACN\> 1.5x103/ml
2. Adequate renal function (GFR\>30 ml/min)\*, creatinine \<1.5 mg/dl
3. Adequate liver function (Bilirubin \<1.8 mg/dl, ALAT and ASPAT, AP \<5 ULN (ULN - upper limit of normal) \* The patient may be qualificated to supportive treatment if the patient's condition is stable.
* Life expectancy of at least 6 months;
* The tumor parameters that can be measured objectively as the size to be assessed in radiological studies on the basis of the RECIST 1.0 and RECIST 1.1;
* In the absence of the ability to measure tumor size based on RECIST criteria, they have tumor parameters that can be measured objectively as tumor markers determined in the blood or urine CgA, 5HIAA;
* Study treatment both planned and able to start within 28 days of inclusion;
* Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments;
* Signed, written informed consent.
* All patients with histologically proven, well/moderate-differentiated G1/2 GEP-NET (according to WHO 2017 classification), with Ki-67 ≤20%, in selected cases patients with NETG3 will be included if there will be reported well/moderate morphological appearance but Ki-67\>20% but less then Ki\<30% (pancreatic, midgut NET and cancer with unknown primary (CUP)); and there will be high expression of somatostatin receptor seen in functional imaging utilized functional imaging 99mTc HYNICTOC or 68Ga DOTATATE or 68Ga DOTATOC;
* The presence of high expression of somatostatin receptors demonstrated on Somatostatin Receptor Imaging using 99mTc HYNICTOC (SPECT) or 68Ga DOTATATE or 68Ga DOTATOC (PET) scans, et least as uptake in not involved liver, Krenning \>2;
* Non-resectable, advanced determined by an appropriately specialized surgeon or deemed not suitable for liver directed therapies where liver is the only site of disease;
* Performance status (PS) based on ECOG 0-2;
* Unresectable, advanced/metastatic progressive disease evaluated as clinical, biochemical, bad control symptoms of tumour hypersecretion or disease progression seen in imaging structural or functional;
* Parameteres of laboratory test:
1. Morphology: Hb\>10g/dl, PLT\>75x103/ml, WBC\> 2x103 /ml with ACN\> 1.5x103/ml
2. Adequate renal function (GFR\>30 ml/min)\*, creatinine \<1.5 mg/dl
3. Adequate liver function (Bilirubin \<1.8 mg/dl, ALAT and ASPAT, AP \<5 ULN (ULN - upper limit of normal) \* The patient may be qualificated to supportive treatment if the patient's condition is stable.
* Life expectancy of at least 6 months;
* The tumor parameters that can be measured objectively as the size to be assessed in radiological studies on the basis of the RECIST 1.0 and RECIST 1.1;
* In the absence of the ability to measure tumor size based on RECIST criteria, they have tumor parameters that can be measured objectively as tumor markers determined in the blood or urine CgA, 5HIAA;
* Study treatment both planned and able to start within 28 days of inclusion;
* Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments;
* Signed, written informed consent.
Exclusion Criteria
* Patients \<18 years old;
* Coexistence of another cancer during recent 5 years, except cancers treated with curative intention and confirmed cured in follow-up with no or low risk of relapse;
* Allergy on somatostatin receptor analogues or capecitabine and temozolomide;
* Previous cytotoxic chemotherapy e.g. CAPTEM, and/or radiopeptide therapy PRRT;
* Pre-existing locoregional treatment such as radiomebolization (SIRspheres) or HDR brachytherapy under CT control, performed in the last 6 months;
* Uncontrolled metastases to the central nervous system, in the case of surgical and/or radiotherapeutic treatment, patients should remain on a stable dose of steroids for at least 2 weeks before enrollment, without deterioration of the general state associated with the presence of metastatic disease in the CNS;
* Poorly controlled concurrent medical illness. E.g. unstable diabetes with glycosylated hemoglobin (HbA1c\> 9.0), the optimal glycaemic control should be achieved before starting trial therapy);
* Major surgery/surgical therapy for any cause within three months before starting trial therapy;
* Symptomatic heart failure NYHA class III or IV, congestive cardiac failure, myocardial infarction in the last 6 months, serious uncontrolled cardiac arrhythmia, unstable angina, or other serious cardiac problems;
* Patients with malabsorption or other gastrointestinal disorders that may interfere with the oral absorption of capecitabine and temozolomide (e.g. colitis ulcerosa, persistent nausea, vomiting, persistent diarrhea) not suitable for conservative treatment and no reaction to SST receptor analogs (Sandostatin LAR or Somatulina Autogel), malabsorption syndrome, short bowel syndrome after resection
* Active uncontrolled infection, including Hepatitis and Hepatitis, HIV, in the case of HCV and HBV infection, the patient can be included in the study confirming the suppression of viral replication and the patient remains on the correct therapeutic dose of antiviral drugs;
* Pregnant patients (a negative pregnancy test is required);
* Women of childbearing age must present a negative pregnancy test at the beginning of the study and must use double barrier to contraception. Women of childbearing age are defined as menopausal if they remain not menstrual for at least 1 year, or surgical sterilization or removal of the uterus before the start of the study;
* Breast-feeding female patients;
* Patients in a mental state who can't understand the nature, extent and possible consequences of participating in the study associated with radioisotope treatment, or there is evidence of a lack of cooperation by the patient;
* Exclusive clinical and laboratory findings that may compromise the patient's safety or reduce the chances of obtaining satisfactory data to achieve the goal (s) of the study;
* Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse;
* The patient may be included in the maintenance treatment if the patient's clinical condition is stable.
* Coexistence of another cancer during recent 5 years, except cancers treated with curative intention and confirmed cured in follow-up with no or low risk of relapse;
* Allergy on somatostatin receptor analogues or capecitabine and temozolomide;
* Previous cytotoxic chemotherapy e.g. CAPTEM, and/or radiopeptide therapy PRRT;
* Pre-existing locoregional treatment such as radiomebolization (SIRspheres) or HDR brachytherapy under CT control, performed in the last 6 months;
* Uncontrolled metastases to the central nervous system, in the case of surgical and/or radiotherapeutic treatment, patients should remain on a stable dose of steroids for at least 2 weeks before enrollment, without deterioration of the general state associated with the presence of metastatic disease in the CNS;
* Poorly controlled concurrent medical illness. E.g. unstable diabetes with glycosylated hemoglobin (HbA1c\> 9.0), the optimal glycaemic control should be achieved before starting trial therapy);
* Major surgery/surgical therapy for any cause within three months before starting trial therapy;
* Symptomatic heart failure NYHA class III or IV, congestive cardiac failure, myocardial infarction in the last 6 months, serious uncontrolled cardiac arrhythmia, unstable angina, or other serious cardiac problems;
* Patients with malabsorption or other gastrointestinal disorders that may interfere with the oral absorption of capecitabine and temozolomide (e.g. colitis ulcerosa, persistent nausea, vomiting, persistent diarrhea) not suitable for conservative treatment and no reaction to SST receptor analogs (Sandostatin LAR or Somatulina Autogel), malabsorption syndrome, short bowel syndrome after resection
* Active uncontrolled infection, including Hepatitis and Hepatitis, HIV, in the case of HCV and HBV infection, the patient can be included in the study confirming the suppression of viral replication and the patient remains on the correct therapeutic dose of antiviral drugs;
* Pregnant patients (a negative pregnancy test is required);
* Women of childbearing age must present a negative pregnancy test at the beginning of the study and must use double barrier to contraception. Women of childbearing age are defined as menopausal if they remain not menstrual for at least 1 year, or surgical sterilization or removal of the uterus before the start of the study;
* Breast-feeding female patients;
* Patients in a mental state who can't understand the nature, extent and possible consequences of participating in the study associated with radioisotope treatment, or there is evidence of a lack of cooperation by the patient;
* Exclusive clinical and laboratory findings that may compromise the patient's safety or reduce the chances of obtaining satisfactory data to achieve the goal (s) of the study;
* Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse;
* The patient may be included in the maintenance treatment if the patient's clinical condition is stable.
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Sponsor Role
collaborator
Medical University of Warsaw
OTHER
Sponsor Role
collaborator
The Diagnostic and Therapeutic Center Gammed; Poland
UNKNOWN
Sponsor Role
collaborator
National Center for Research and Development, Poland
OTHER
Sponsor Role
collaborator
University of Warmia and Mazury
OTHER
Sponsor Role
lead
Responsible Party
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Jaroslaw B. Cwikla, MD, PhD, Professor UWM
Head of Department of Nuclear Medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Centrum Diagnostyczno-Lecznicze Gammed
Warsaw, , Poland
Site Status
RECRUITING
Countries
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Poland
Central Contacts
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Facility Contacts
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References
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Strosberg JR, Fine RL, Choi J, Nasir A, Coppola D, Chen DT, Helm J, Kvols L. First-line chemotherapy with capecitabine and temozolomide in patients with metastatic pancreatic endocrine carcinomas. Cancer. 2011 Jan 15;117(2):268-75. doi: 10.1002/cncr.25425. Epub 2010 Sep 7.
Reference Type
BACKGROUND
Welin S, Sorbye H, Sebjornsen S, Knappskog S, Busch C, Oberg K. Clinical effect of temozolomide-based chemotherapy in poorly differentiated endocrine carcinoma after progression on first-line chemotherapy. Cancer. 2011 Oct 15;117(20):4617-22. doi: 10.1002/cncr.26124. Epub 2011 Mar 31.
Reference Type
BACKGROUND
Fine RL, Gulati AP, Krantz BA, Moss RA, Schreibman S, Tsushima DA, Mowatt KB, Dinnen RD, Mao Y, Stevens PD, Schrope B, Allendorf J, Lee JA, Sherman WH, Chabot JA. Capecitabine and temozolomide (CAPTEM) for metastatic, well-differentiated neuroendocrine cancers: The Pancreas Center at Columbia University experience. Cancer Chemother Pharmacol. 2013 Mar;71(3):663-70. doi: 10.1007/s00280-012-2055-z. Epub 2013 Jan 31.
Reference Type
BACKGROUND
Saif MW, Kaley K, Brennan M, Garcon MC, Rodriguez G, Rodriguez T. A retrospective study of capecitabine/temozolomide (CAPTEM) regimen in the treatment of metastatic pancreatic neuroendocrine tumors (pNETs) after failing previous therapy. JOP. 2013 Sep 10;14(5):498-501. doi: 10.6092/1590-8577/1589.
Reference Type
BACKGROUND
Peixoto RD, Noonan KL, Pavlovich P, Kennecke HF, Lim HJ. Outcomes of patients treated with capecitabine and temozolamide for advanced pancreatic neuroendocrine tumors (PNETs) and non-PNETs. J Gastrointest Oncol. 2014 Aug;5(4):247-52. doi: 10.3978/j.issn.2078-6891.2014.019.
Reference Type
BACKGROUND
Koumarianou A, Kaltsas G, Kulke MH, Oberg K, Strosberg JR, Spada F, Galdy S, Barberis M, Fumagalli C, Berruti A, Fazio N. Temozolomide in Advanced Neuroendocrine Neoplasms: Pharmacological and Clinical Aspects. Neuroendocrinology. 2015;101(4):274-88. doi: 10.1159/000430816. Epub 2015 Apr 29.
Reference Type
BACKGROUND
De Divitiis C, von Arx C, Grimaldi AM, Cicala D, Tatangelo F, Arcella A, Romano GM, Simeone E, Iaffaioli RV, Ascierto PA, Tafuto S; European Neuroendocrine Tumor Society (ENETS) Center of Excellence-Multidisciplinary Group for Neuroendocrine Tumors in Naples (Italy). Metronomic temozolomide as second line treatment for metastatic poorly differentiated pancreatic neuroendocrine carcinoma. J Transl Med. 2016 May 3;14(1):113. doi: 10.1186/s12967-016-0857-1.
Reference Type
BACKGROUND
Ramirez RA, Beyer DT, Chauhan A, Boudreaux JP, Wang YZ, Woltering EA. The Role of Capecitabine/Temozolomide in Metastatic Neuroendocrine Tumors. Oncologist. 2016 Jun;21(6):671-5. doi: 10.1634/theoncologist.2015-0470. Epub 2016 May 25.
Reference Type
BACKGROUND
Kwekkeboom DJ, de Herder WW, Kam BL, van Eijck CH, van Essen M, Kooij PP, Feelders RA, van Aken MO, Krenning EP. Treatment with the radiolabeled somatostatin analog [177 Lu-DOTA 0,Tyr3]octreotate: toxicity, efficacy, and survival. J Clin Oncol. 2008 May 1;26(13):2124-30. doi: 10.1200/JCO.2007.15.2553.
Reference Type
BACKGROUND
Cwikla JB, Sankowski A, Seklecka N, Buscombe JR, Nasierowska-Guttmejer A, Jeziorski KG, Mikolajczak R, Pawlak D, Stepien K, Walecki J. Efficacy of radionuclide treatment DOTATATE Y-90 in patients with progressive metastatic gastroenteropancreatic neuroendocrine carcinomas (GEP-NETs): a phase II study. Ann Oncol. 2010 Apr;21(4):787-794. doi: 10.1093/annonc/mdp372. Epub 2009 Oct 15.
Reference Type
BACKGROUND
Bodei L, Cremonesi M, Grana CM, Fazio N, Iodice S, Baio SM, Bartolomei M, Lombardo D, Ferrari ME, Sansovini M, Chinol M, Paganelli G. Peptide receptor radionuclide therapy with (1)(7)(7)Lu-DOTATATE: the IEO phase I-II study. Eur J Nucl Med Mol Imaging. 2011 Dec;38(12):2125-35. doi: 10.1007/s00259-011-1902-1. Epub 2011 Sep 3.
Reference Type
BACKGROUND
Hicks RJ, Kwekkeboom DJ, Krenning E, Bodei L, Grozinsky-Glasberg S, Arnold R, Borbath I, Cwikla J, Toumpanakis C, Kaltsas G, Davies P, Horsch D, Tiensuu Janson E, Ramage J; Antibes Consensus Conference participants. ENETS Consensus Guidelines for the Standards of Care in Neuroendocrine Neoplasia: Peptide Receptor Radionuclide Therapy with Radiolabeled Somatostatin Analogues. Neuroendocrinology. 2017;105(3):295-309. doi: 10.1159/000475526. Epub 2017 Apr 13. No abstract available.
Reference Type
BACKGROUND
Claringbold PG, Turner JH. Pancreatic Neuroendocrine Tumor Control: Durable Objective Response to Combination 177Lu-Octreotate-Capecitabine-Temozolomide Radiopeptide Chemotherapy. Neuroendocrinology. 2016;103(5):432-9. doi: 10.1159/000434723. Epub 2015 Jun 10.
Reference Type
BACKGROUND
Claringbold PG, Brayshaw PA, Price RA, Turner JH. Phase II study of radiopeptide 177Lu-octreotate and capecitabine therapy of progressive disseminated neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2011 Feb;38(2):302-11. doi: 10.1007/s00259-010-1631-x. Epub 2010 Oct 30.
Reference Type
BACKGROUND
Other Identifiers
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POLNETS_2018
Identifier Type: -
Identifier Source: org_study_id