Clinical trial · Interventional
GM-CSF and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Colon Cancer
A PHASE II Study of GM-CSF As Pre- And Post-operative Adjuvant Therapy For Stage II And III Colon 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: Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy or kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. PURPOSE: This phase II trial is studying how well GM-CSF and combination chemotherapy work in treating patients who are undergoing surgery for stage II or stage III colon 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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of patients with a change in tumor-associated macrophage VEGF expression
Secondary outcomes (1)
- measure
- Disease-free and overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon * Stage II or III disease * No carcinoma in situ * No perforated or obstructed tumors * No dual primary lesions by colonoscopy or barium enema * Resectable disease * Distal and proximal bowel end must be \> 5 cm from tumor * Tumor must not extend below peritoneal reflection * No distant intra-abdominal metastases (even if resected) * No rectal cancer * No tumors that require opening of the pelvic peritoneum to define the extent of disease PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 2.0 mg/dL Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No uncontrolled cardiac arrhythmia Immunologic * No ongoing or active infection * No allergy to yeast or yeast-based products * No allergy to sargramostim (GM-CSF) * No allergy to fluorouracil * No allergy to leucovorin calcium Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of Crohn's disease * No history of ulcerative colitis * No other malignancy within the past 3 years except superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness PRIOR CONCURRENT THERAPY: Chemotherapy * No prior chemotherapy, including fluorouracil, for colon cancer * No other concurrent chemotherapy Radiotherapy * No prior radiotherapy for colon cancer * No concurrent radiotherapy Other * No other prior therapy for colon cancer * No concurrent immunosuppressant therapy * No other concurrent investigational agents * No other concurrent anticancer therapy
References
Publications (1)
- DERIVEDBourigault P, Skwarski M, Macpherson RE, Higgins GS, McGowan DR. Investigation of atovaquone-induced spatial changes in tumour hypoxia assessed by hypoxia PET/CT in non-small cell lung cancer patients. EJNMMI Res. 2021 Dec 29;11(1):130. doi: 10.1186/s13550-021-00871-x. PMID 34964932