Clinical trial · Interventional
Gemcitabine and Radiation Therapy Compared With Gemcitabine Alone in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer
Randomized Phase II/III Study Comparing Gemcitabine Followed by Gemcitabine Plus Concomitant Radiation (50.4 Gy) Versus Control After Curative Pancreaticoduodenectomy for Pancreatic Head Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving gemcitabine together with radiation therapy is more effective than gemcitabine alone following surgery in treating pancreatic cancer. PURPOSE: This randomized phase II/III trial is studying how well giving gemcitabine together with radiation therapy works and compares it to gemcitabine alone in treating patients who have undergone surgery for pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Feasibility of full completion of treatment as measured by the number of patients completing treatment 1 month after treatment in phase II
- measure
- Tolerability in terms of acute toxicity as measured by NCI-CTC v2.0 1 month after completion of treatment in phase II
- measure
- Tolerability in terms of late toxicity as measured by EORTC and RTOG 1 month after completion of treatment in phase II
- measure
- Overall survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter in phase III
Secondary outcomes (4)
- measure
- Disease-free survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter
- measure
- Acute toxicity as measured by NCI-CTC v2.0 every 3 months in years 1-2, and every 6 months thereafter
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed pancreatic head adenocarcinoma * Prior pancreaticoduodenectomy required * Documented histological examination of surgical margins (R0), including retroperitoneal margin * Performed within the past 8 weeks * Any number of lymph nodes (less than 10 OR 10 or more) allowed * No periampullary cancer PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * WHO 0-2 Life expectancy * Not specified Hematopoietic * WBC greater than 3,500/mm\^3 * Platelet count greater than 150,000/mm\^3 * Hemoglobin greater than 9.0 g/dL Hepatic * Bilirubin less than 1.5 times normal * AST and ALT less than 3.0 times normal Renal * Creatinine less than 1.2 mg/dL Other * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix * No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy Surgery * See Disease Characteristics * Recovered from prior surgery Other * No other concurrent anticancer agents
References
Publications (3)
- RESULTVan Laethem JL, Hammel P, Mornex F, Azria D, Van Tienhoven G, Vergauwe P, Peeters M, Polus M, Praet M, Mauer M, Collette L, Budach V, Lutz M, Van Cutsem E, Haustermans K. Adjuvant gemcitabine alone versus gemcitabine-based chemoradiotherapy after curative resection for pancreatic cancer: a randomized EORTC-40013-22012/FFCD-9203/GERCOR phase II study. J Clin Oncol. 2010 Oct 10;28(29):4450-6. doi: 10.1200/JCO.2010.30.3446. Epub 2010 Sep 13. PMID 20837948
- RESULTVan Laethem JL, Mornex F, Azria D, et al.: Adjuvant gemcitabine alone versus gemcitabine-based chemoradiation after curative resection for pancreatic cancer: updated results of a randomized EORTC/FFCD/GERCOR phase II study (40013-22012/9203). [Abstract] J Clin Oncol 27 (Suppl 15): A-4527, 2009.
- RESULTVan Laethem J, Van Cutsem E, Hammel P, et al.: Adjuvant chemotherapy alone versus chemoradiation after curative resection for pancreatic cancer : feasibility results of a randomised EORTC/FFCD/GERCOR phase II/III study (40013/22012/0304). [Abstract] J Clin Oncol 26 (Suppl 15): A-4514, 2008.