Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00149578
Status:
UNKNOWN
Last Update Posted:
2007-05-17
First Post:
2005-09-07
Brief Title:
A Phase II Study of Combine Modality Therapy in Locally Advanced Pancreatic Cancer
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
A Phase II Study of Induction Chemotherapy Followed by Concurrent Chemotherapy With Radiotherapy in Locally Advanced Pancreatic Cancer
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Induction chemotherapy will be administered every 2 weeks for 6 cycles about 3 months Patients who have radiological evidence of progressive disease will be shifted to salvage chemotherapy Patients who have responsive or stable disease after induction chemotherapy will receive concurrent chemoradiotherapy 3-4 weeks after the last dose of induction chemotherapy Surgical evaluation will be performed 4-6 weeks after the completion of chemoradiotherapy Patients who have resectable disease will undergo surgical resection Postoperative adjuvant chemotherapy with GOFL for 6 cycles will be given for those who have curative resection Patients who still have unresectable disease or non-curative resection will receive systemic chemotherapy of GOFL till disease progression or unacceptable toxicity
Detailed Description:
Induction chemotherapy will be administered on a biweekly basis Reported adverse events and potential risks for gemcitabine oxaliplatin 5-FU and leucovorin are described in Section 6 Appropriate dose modifications for are described in Section 5 No investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patients malignancy
411 Treatment schedule of induction chemotherapy
For each dose of GOFL chemotherapy intravenous infusion of gemcitabine at a fixed rate of 10 mgm2min will be immediately followed by a 2-hour intravenous infusion of oxaliplatin and then a 48-hour intravenous infusion of 5-FU and leucovorin
412 Premedication before chemotherapy
Patients will receive 4mg of dexamethasone and anti-histamine and appropriate anti-emetics serotonin antagonists before each dose of chemotherapy
42 Supportive Care Guidelines
Prophylactic G-CSF or GM-CSF will not be routinely used in this study In case of febrile neutropenia patients should be treated with appropriate antibiotics Therapeutic G-CSF may be used at the discretion of attending physicians
43 Duration of Induction Chemotherapy
In the absence of treatment delays due to adverse events treatment may continue for 6 cycles or until one of the following criteria applies
C Disease progression C Intercurrent illness that prevents further administration of treatment C Unacceptable adverse eventss C Patient decides to withdraw from the study or C General or specific changes in the patients condition render the patient unacceptable for further treatment in the judgment of the investigator
44 Agents and Radiation Administration during Concurrent Chemoradiotherapy
441 Treatment schedule during concurrent chemoradiotherapy
4411 Patient selection
Patients were evaluated after 6 cycles of induction chemotherapy Patients who have progressive disease either due to distant metastasis or locoregional progression will be given salvage systemic chemotherapy and will not be enrolled into concurrent chemoradiotherapy Patients who achieve complete remission partial remission or stable disease will be enrolled into 2nd phase of the study concurrent chemoradiotherapy 3-4 weeks after the last dose of induction chemotherapy
442 Study Agents
Gemcitabine 400mgm2 will be dissolved in 250ml normal saline and infused intravenously at a fixed rate of 10mgm2min for 40 mins
4412 Treatment schedule
Gemcitabine 400mgm2 in 250ml normal saline will be iv infused for 40mins 2hrs before RT on day 1 8 15 22 29 36 Radiation will be given 180cGy per day 5 days a week for 28 fractions to totally 5040cGy
4413 Premedication for concurrent chemoradiotherapy
Patients were given dexamethasone 2mg orally three times a day tid from the morning of their first radiotherapy fraction The prophylactic dexamethasone will be continued until after they had received their fifth radiation treatment Therefore depending on the day of the week the patients started treatment dexamethasone will be taken for 5 to 7 days All patients will be issued with rescue medication prochlorperazine 10mg every 6 hours orally if they develop nausea and vomiting If patients still have nausea andor vomiting during treatment of dexamethasone and prochlorperazine or after the fifth day of radiotherapy ondansetron 8mg orally or iv one to three times per day or granisetron 1mg per os or iv once everyday 30mins before radiotherapy should be given
443 Radiation
4431 Radiation technique
Radiation should be performed by high-energy linear accelerators Three-dimensional radiation treatment planning was used in all cases Patients will be immobilized in a foam cradle in a supine position and the treatment planning CT was obtained Tumor mapping should be performed according to treatment planning CT and the diagnostic CT before induction chemotherapy Treatment planning was performed with the isocenter calculated at 100 and the 95 line encompassing the planning target volume The spinal cord was limited to 4600cGy If one kidney was to receive more than 20Gy then more than 90 of the remaining kidney was excluded from the primary beam Generally a three-field no-axial beam arrangement opposed lateral with an anterior-inferior oblique was used
4432 Radiation volume
The gross tumor volume is the primary tumor identifiable on CT scan before induction chemotherapy The clinical target volume was defined as the gross tumor volume plus 05cm The planning target volume was the clinical target volume plus 05cm for daily patient set-up variation No prophylactic nodal irradiation will be given
4433 Radiation dosage
A total dose of 5040cGy in 28 fractions 180cGy per fraction one fraction per day 5 days per week will be given
45 Surgery
451 Surgical evaluation
Patients completed induction chemotherapy and concurrent chemoradiotherapy will be evaluated for surgical resection If there is evidence of distant metastasis surgery will not be arranged The feasibility of surgical resection will be evaluated by qualified surgeon according to contrast-enhanced abdominal CT or MRI Laparoscope is optional for pre-surgical evaluation
4511 Resectable l No distant metastases l Clear fat plane around celiac and superior mesenteric arteries SMA l Patent superior mesenteric vein SMVportal vein 4512 Borderline resectable l Severe unilateral SMVportal impingement l Tumor abutment on SMA l Gastroduodenal artery GDA encasement up to origin at hepatic artery l Colon or mesocolon invasion l Adrenal colon or mesocolon or kidney invasion 4513 Unresectable l Distant metastases l SMA celiac encasement l SMVportal occlusion l Aortic inferior vena cava IVC invasion or encasement l Invasion of SMV below transverse mesocolon l Rib vertebral invasion
452 Treatment schedule of surgery
Surgery will be performed within 4-6 weeks after chemoradiotherapy complete
453 Surgical technique
Patients whose tumor are considered to be resectable will undergo laparotomy If complete surgical resection is feasible optimal surgery will be performed If complete surgical resection is impossible biopsy with or without palliative surgery eg bypass surgery may be performed 46 AdjuvantMaintenance Chemotherapy
461 Treatment schedule
Patients who have curative surgical resection will receive 6 cycles of adjuvant GOFL chemotherapy within 4 weeks after surgery and then followed up until tumor progression Patients who are not feasible for curative resection will receive continued chemotherapy of GOFL 3-4 weeks after chemoradiotherapy complete The regimen will continue till disease progression Patients who develop progressive disease during GOFL will shift to salvage chemotherapy
411 Treatment schedule of induction chemotherapy
For each dose of GOFL chemotherapy intravenous infusion of gemcitabine at a fixed rate of 10 mgm2min will be immediately followed by a 2-hour intravenous infusion of oxaliplatin and then a 48-hour intravenous infusion of 5-FU and leucovorin
412 Premedication before chemotherapy
Patients will receive 4mg of dexamethasone and anti-histamine and appropriate anti-emetics serotonin antagonists before each dose of chemotherapy
42 Supportive Care Guidelines
Prophylactic G-CSF or GM-CSF will not be routinely used in this study In case of febrile neutropenia patients should be treated with appropriate antibiotics Therapeutic G-CSF may be used at the discretion of attending physicians
43 Duration of Induction Chemotherapy
In the absence of treatment delays due to adverse events treatment may continue for 6 cycles or until one of the following criteria applies
C Disease progression C Intercurrent illness that prevents further administration of treatment C Unacceptable adverse eventss C Patient decides to withdraw from the study or C General or specific changes in the patients condition render the patient unacceptable for further treatment in the judgment of the investigator
44 Agents and Radiation Administration during Concurrent Chemoradiotherapy
441 Treatment schedule during concurrent chemoradiotherapy
4411 Patient selection
Patients were evaluated after 6 cycles of induction chemotherapy Patients who have progressive disease either due to distant metastasis or locoregional progression will be given salvage systemic chemotherapy and will not be enrolled into concurrent chemoradiotherapy Patients who achieve complete remission partial remission or stable disease will be enrolled into 2nd phase of the study concurrent chemoradiotherapy 3-4 weeks after the last dose of induction chemotherapy
442 Study Agents
Gemcitabine 400mgm2 will be dissolved in 250ml normal saline and infused intravenously at a fixed rate of 10mgm2min for 40 mins
4412 Treatment schedule
Gemcitabine 400mgm2 in 250ml normal saline will be iv infused for 40mins 2hrs before RT on day 1 8 15 22 29 36 Radiation will be given 180cGy per day 5 days a week for 28 fractions to totally 5040cGy
4413 Premedication for concurrent chemoradiotherapy
Patients were given dexamethasone 2mg orally three times a day tid from the morning of their first radiotherapy fraction The prophylactic dexamethasone will be continued until after they had received their fifth radiation treatment Therefore depending on the day of the week the patients started treatment dexamethasone will be taken for 5 to 7 days All patients will be issued with rescue medication prochlorperazine 10mg every 6 hours orally if they develop nausea and vomiting If patients still have nausea andor vomiting during treatment of dexamethasone and prochlorperazine or after the fifth day of radiotherapy ondansetron 8mg orally or iv one to three times per day or granisetron 1mg per os or iv once everyday 30mins before radiotherapy should be given
443 Radiation
4431 Radiation technique
Radiation should be performed by high-energy linear accelerators Three-dimensional radiation treatment planning was used in all cases Patients will be immobilized in a foam cradle in a supine position and the treatment planning CT was obtained Tumor mapping should be performed according to treatment planning CT and the diagnostic CT before induction chemotherapy Treatment planning was performed with the isocenter calculated at 100 and the 95 line encompassing the planning target volume The spinal cord was limited to 4600cGy If one kidney was to receive more than 20Gy then more than 90 of the remaining kidney was excluded from the primary beam Generally a three-field no-axial beam arrangement opposed lateral with an anterior-inferior oblique was used
4432 Radiation volume
The gross tumor volume is the primary tumor identifiable on CT scan before induction chemotherapy The clinical target volume was defined as the gross tumor volume plus 05cm The planning target volume was the clinical target volume plus 05cm for daily patient set-up variation No prophylactic nodal irradiation will be given
4433 Radiation dosage
A total dose of 5040cGy in 28 fractions 180cGy per fraction one fraction per day 5 days per week will be given
45 Surgery
451 Surgical evaluation
Patients completed induction chemotherapy and concurrent chemoradiotherapy will be evaluated for surgical resection If there is evidence of distant metastasis surgery will not be arranged The feasibility of surgical resection will be evaluated by qualified surgeon according to contrast-enhanced abdominal CT or MRI Laparoscope is optional for pre-surgical evaluation
4511 Resectable l No distant metastases l Clear fat plane around celiac and superior mesenteric arteries SMA l Patent superior mesenteric vein SMVportal vein 4512 Borderline resectable l Severe unilateral SMVportal impingement l Tumor abutment on SMA l Gastroduodenal artery GDA encasement up to origin at hepatic artery l Colon or mesocolon invasion l Adrenal colon or mesocolon or kidney invasion 4513 Unresectable l Distant metastases l SMA celiac encasement l SMVportal occlusion l Aortic inferior vena cava IVC invasion or encasement l Invasion of SMV below transverse mesocolon l Rib vertebral invasion
452 Treatment schedule of surgery
Surgery will be performed within 4-6 weeks after chemoradiotherapy complete
453 Surgical technique
Patients whose tumor are considered to be resectable will undergo laparotomy If complete surgical resection is feasible optimal surgery will be performed If complete surgical resection is impossible biopsy with or without palliative surgery eg bypass surgery may be performed 46 AdjuvantMaintenance Chemotherapy
461 Treatment schedule
Patients who have curative surgical resection will receive 6 cycles of adjuvant GOFL chemotherapy within 4 weeks after surgery and then followed up until tumor progression Patients who are not feasible for curative resection will receive continued chemotherapy of GOFL 3-4 weeks after chemoradiotherapy complete The regimen will continue till disease progression Patients who develop progressive disease during GOFL will shift to salvage chemotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None