Clinical Study: Treatment of Acromegaly With a Somatostatin Analog Before Pituitary Surgery for Acromegaly
The aim of the study is to evaluate the interest of a six month pre-operative treatment with a long-acting somatostatin analog (Sandostatin LP) versus surgery alone in patients with a pituitary adenoma responsible for acromegaly. Full name of Clinical Study: Treatment of Acromegaly With a Somatostatin Analog Before Pituitary Surgery for Acromegaly: Comparison With Neurosurgery Alone (SAPORO)
Detailed Description
Somatotroph pituitary adenoma is the most frequent cause of acromegaly. A transsphenoidal removal of the tumor is used as the first line treatment. Somatostatin analogs are used as to whether recovery was not obtained after surgery or pituitary surgery was contraindicated. Previous studies with somatostatin analogs have shown a drop in plasma GH and IGF-1 levels and a reduction in adenoma size in 75 and 25% of patients respectively. Retrospective studies suggest that a treatment with somatostatin analogs performed before surgery may be of interest to improve anesthesic conditions and surgical outcome. The aim of present study is to prospectively evaluate the interest of a first line treatment with a long-acting somatostatin analog (Sandostatin) before performing a pituitary surgery in acromegalic patients with either a micro or a macroadenoma to improve peri-operative conditions and hopefully surgical outcome.
After informed consent, untreated acromegalic patients will be included and randomly assigned to one of the following treatment procedures : either pituitary surgery or a six month treatment with long-acting Sandostatin 30 mg monthly for 6 months before performing transsphenoïdal adenoma removal. The patients will be evaluated before any treatment, on months 3 and 6 of the treatment with Sandostatin (for the patients enrolled in this arm of the study) and on months 3 and 12 after pituitary neurosurgery. Each evaluation will include clinical data, hormone testing and radiological (MRI) investigation. The main endpoint will be the rate of recovery proved by a normalisation of GH secretion and plasma IGF-1 level. Secondary endpoints will include the evaluation of clinical, radiological, biological, anesthesic, surgical and pathological parameters. A comparison between the two arms will be performed at entry into the study, at the time of surgery and then on months 3 and 12 following the transsphenoidal removal of the somatotroph adenoma.
This study is currently recruiting participants.
Verified by University Hospital, Rouen, December 2009
First Received: December 7, 2009 Last Updated: December 8, 2009 History of Changes
| Sponsor: | University Hospital, Rouen |
| Information provided by: | University Hospital, Rouen |
| ClinicalTrials.gov Identifier: | NCT01029275 |
| Condition | Intervention |
| Acromegaly | Drug: Pre-treatment with octreotide Other: no treatment before pituitary surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Multicenter, Randomised Open Trial Comparing the Efficacy of a Medical Treatment With Sandostatin LP 30 mg Performed Before Surgery to a Prime Line transsphenoïdal Surgery in Previously Untreated Acromegalic Patients With Either a Micro or a Macro Pituitary Adenoma |
Primary Outcome Measures:
- IGF1 plasma levels [ Time Frame: 3 months and 12 months after transphenoidal surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- GH plasma levels [ Time Frame: 3 and 12 months after transphenoidal surgery ] [ Designated as safety issue: No ]
- Evaluation of the effects of the pre-operative treatment with Sandostatin on clinical, radiological, biological, anesthesic, surgical and pathological parameters. [ Time Frame: at transphenoidal surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| Arm A: Experimental
pre-operative medical treatment with Sandostatin |
Drug: Pre-treatment with octreotide
Pre-treatment with octreotide |
| Arm B: No Intervention
pituitary surgery as a first line treatment |
Other: no treatment before pituitary surgery
no treatment before pituitary surgery |
Eligibility
| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- men and women
- 18-80 years old
- untreated acromegaly
- unsuppressed GH secretion after a glucose load and elevated IGF-1 plasma levels
- presence of a pituitary adenoma on MRI
- informed consent given.
Exclusion Criteria:
- acromegaly previously treated
- contraindication to pituitary surgery
- associated hyperprolactinemia above 200 ng/ml
- visual field defect needing rapid transsphenoidal surgery
- contraindication to a treatment with octreotide
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029275
Contacts
| Contact: Sabrina Prodhomme, CRA | 00 33 (0)2 32 88 82 65 | sabrina.prodhomme@chu-rouen.fr |
Locations
| France | |
| Angers University Hospital | Recruiting |
| Angers, France, 49000 | |
| Contact: Vincent Rohmer, MD, PhD 00 33 (0)2 41 35 34 24 | |
| Principal Investigator: Vincent Rohmer, MD, PhD | |
| Besançon University Hospital | Recruiting |
| Besançon, France, 25000 | |
| Contact: Alfred Penformis 00 33 (0)3 81 66 81 92 | |
| Principal Investigator: Alfred Penformis, MD, PhD | |
| Caen University Hospital | Recruiting |
| Caen, France, 14000 | |
| Contact: Yves Reznik, MD, PhD 00 33 (0)2 31 93 82 92 reznik-y@chu-caen.fr | |
| Sub-Investigator: Mickael Joubert, MD | |
| Principal Investigator: Yves Reznik, MD,PhD | |
| Grenoble University Hospital | Recruiting |
| Grenoble, France, 38000 | |
| Contact: Olivier Chabre, MD, PhD 00 33 (0)4 76 76 54 39 | |
| Principal Investigator: Olivier Chabre, MD, PhD | |
| Paris XI University Hospital | Recruiting |
| Le Kremlin Bicetre, France, 94000 | |
| Contact: Philippe Chanson, MD, PhD 00 33 (0)1 45 21 37 05 philippe.chanson@bct.ap-hop-paris.fr | |
| Principal Investigator: Philippe Chanson, MD, PhD | |
| Lille University Hospital | Recruiting |
| Lille, France, 59000 | |
| Contact: Jean L Wemeau, MD, PhD 00 33 (0)3 20 44 41 18 jl.wemeau@chru-lille.fr | |
| Principal Investigator: Jean L Wemeau, MD, PhD | |
| Toulouse Universtiy Hospital | Recruiting |
| Toulouse, France, 31000 | |
| Contact: Philippe Caron, MD, PhD 00 33 (0)5 61 32 23 44 caron.p@chu-toulouse.fr | |
| Principal Investigator: Philippe Caron, MD, PhD | |
| Lyon University Hospital | Recruiting |
| Lyon, France, 69000 | |
| Contact: Françoise Borson-Chazot, MD, PhD 00 33 (0)4 72 11 93 19 francoise.borson-chazot@chu-lyon.fr | |
| Principal Investigator: Francoise Borson-Chazot, MD, phD | |
| Marseille University Hospital | Recruiting |
| Marseille, France, 13000 | |
| Contact: Thierry Brue, MD, PhD 00 33 (0)4 91 38 65 97 thierry.brue@chu-marseille.fr | |
| Principal Investigator: Thierry Brue, MD, PhD | |
| Bordeaux University Hospital | Recruiting |
| Pessac, France, 33000 | |
| Contact: Antoine Tabarin, MD, PhD 00 33 (0)5 57 65 64 24 | |
| Principal Investigator: Antoine Tabarin, MD, PhD | |
| Rouen University Hospital | Recruiting |
| Rouen, France, 76000 | |
| Contact: Jean M Kuhn, MD, PhD 00 33 (0)2 32 88 90 82 jean-marc.kuhn@chu-rouen.fr | |
| Contact: Anne F Cailleux, MD 00 33 (0)2 32 88 88 62 anne.cailleux@chu-rouen.fr | |
| Principal Investigator: Jean M Kuhn, MD, PhD | |
| Sub-Investigator: Pierre Freger, MD,PhD | |
| Strasbourg University Hospital | Recruiting |
| Strasbourg, France, 67000 | |
| Contact: Jean L Schlienger, MD, PhD 00 33 (0)3 88 12 75 97 | |
| Principal Investigator: Jean L Schlienger, MD, PhD | |
| University Hospital of Limoges | Recruiting |
| Limoges, France, 87000 | |
| Contact: Françoise Archambeau, MD, PhD 00 33 (0)5 55 05 68 51 francoise.archambeau@chu-limoges.fr | |
| Principal Investigator: Françoise Archambeau, MD, PhD | |
| Sub-Investigator: Marie P Tessier, MD, PhD | |
Sponsors and Collaborators
University Hospital, Rouen
Investigators
| Principal Investigator: | Jean M Kuhn, MD, PhD | Rouen University Hospital |
More Information
No publications provided
| Responsible Party: | department of endocrinology, Rouen University Hospital ( Professor Jean-Marc Kuhn ) |
| Study ID Numbers: | 04-089-HP, 2004-004524-12 |
| Study First Received: | December 7, 2009 |
| Last Updated: | December 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT01029275 History of Changes |
| Health Authority: | France: Afssaps – French Health Products Safety Agency |
Keywords provided by University Hospital, Rouen:
| Acromegaly pituitary adenoma octreotide |
transsphenoïdal surgery GH IGF-1 |
Additional relevant MeSH terms:
| Bone Diseases, Endocrine Antineoplastic Agents Octreotide Pituitary Neoplasms Central Nervous System Neoplasms Brain Diseases Bone Diseases Hyperpituitarism Neoplasms by Site Musculoskeletal Diseases Hypothalamic Neoplasms Therapeutic Uses Nervous System Neoplasms |
Endocrine Gland Neoplasms Acromegaly Hypothalamic Diseases Pituitary Diseases Antineoplastic Agents, Hormonal Nervous System Diseases Gastrointestinal Agents Endocrine System Diseases Central Nervous System Diseases Supratentorial Neoplasms Pharmacologic Actions Brain Neoplasms Neoplasms |
Source: ClinicalTrials.gov – processed this record on March 25, 2010
http://clinicaltrials.gov/ct2/show/NCT01029275