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A Randomized Two-armed Open Study on the Adjuvant Therapy in Patients With R0/R1 Resected Pancreatic Carcinoma With Gemcitabine Alone (Arm G) vs. Gemcitabine Plus Cisplatin With Regional Hyperthermia (Arm GPH)


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Resected Pancreatic Adenocarcinoma

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Trial Information

A Randomized Two-armed Open Study on the Adjuvant Therapy in Patients With R0/R1 Resected Pancreatic Carcinoma With Gemcitabine Alone (Arm G) vs. Gemcitabine Plus Cisplatin With Regional Hyperthermia (Arm GPH)


Inclusion Criteria:



1. Any ductal adenocarcinoma of the pancreas confirmed by histology

2. Previous R0 or R1 resection of pancreatic tumor with a standardized procedure

3. No other previous or concomitant treatment of pancreatic carcinoma like radiation,
neoadjuvant therapy or immunotherapy

4. No tumor recurrence after surgery

5. Postoperative tumor marker (CEA/CA19-9) ≤ 2.5 x upper limit of normal (ULN) to be
documented within 1 week prior to randomization

6. Performance status ECOG 0-2

7. Adequate bone marrow function defined as

- WBC count ≥ 3.5 x 109/L and

- platelets ≥ 150 x 109/L and

- haemoglobin ≥ 9 g/dl documented within 1 week prior to randomization

8. Adequate renal function defined as

- serum creatinine ≤ 1.2 mg/dL and

- calculated GFR ≥ 60 mL/min documented within 1 week prior to randomization

9. Adequate coagulatory function defined as

- Quick-value ≥ 70% and

- aPTT ≤ 1.5 x ULN documented within 1 week prior to randomization

10. Transaminases (AST, ALT) ≤ 3 x ULN and bilirubin ≤ 2 x ULN documented within 1 week
prior to randomization

11. At least 18 years of age

12. Women with childbearing potential and fertile men must use adequate contraceptive
measures during and for at least 3 months (female) and 6 months (male) after
completion of study therapy (Adequate methods for women are oral contraceptives with
estrogen and progesterone, vaginal rings, contraceptive patches, estrogen-free
ovulation inhibitors, intrauterine devices with progesterone,3-month injections with
depot progesterone, implants setting free progesterone, abstinence or sterilization
(vasectomy) of the male partner. Men must use condoms.)

13. Women with childbearing potential must have a negative pregnancy test within 1 week
prior to randomization (postmenopausal women with amenorrhea for more than 1 year are
regarded as having no childbearing potential)

14. Written informed consent

Exclusion criteria:

1. Cystic carcinoma of the pancreas

2. Periampullary, papillary cancer

3. Metastatic disease

4. Presence of an active infection grade 3 or higher

5. Other severe disease which could impair the patient's ability to participate in the
study according to the investigator's opinion

6. Pregnant or breastfeeding women

7. Known allergies or contraindications with regard to substances or procedures of study
therapy

8. Severe, non-healing wounds, ulcers or bone fractures

9. Participation in another clinical trial during this study or within 4 weeks prior to
randomization

10. Past or current abuse of illegal or legal drugs or alcohol

11. Other primary malignant diseases in the medical history during the last 5 years
(exceptions: carcinoma in situ of the cervix or adequately treated basal cell
carcinoma of the skin).

12. Permanent cardiac pacemaker

13. Gross adiposity defined as BMI > 40 kg/m²

14. Treatment with regional hyperthermia not possible for technical reasons (e.g. metal
implant)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival (DFS)

Outcome Time Frame:

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Safety Issue:

No

Principal Investigator

Rolf D. Issels, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinikum Grosshadern, Medical Center, University of Munich, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

115-09

NCT ID:

NCT01077427

Start Date:

March 2012

Completion Date:

March 2017

Related Keywords:

  • Resected Pancreatic Adenocarcinoma
  • pancreatic cancer
  • adjuvant treatment
  • hyperthermia
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Fever

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