Clinical trial · Interventional
A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.
A Feasibility Study of Pemetrexed Single Agent and Folic Acid Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer
NCT00330915CI-TRIAL-00002479completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to help answer the following research questions: If the study drug Pemetrexed can help patients with rectal cancer; If molecular biological parameters are correlated respectively changing due to cytotoxic treatment with Pemetrexed; To evaluate adverse events
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 |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: pemetrexed
Primary outcomes (1)
- measure
- Feasibility of Pemetrexed Prior to Surgery
- timeFrame
- 3 cycles (21-day cycles)
- description
- Feasibility was defined as the ability to receive the total planned dose of Pemetrexed administered over a period of no more than 9 weeks permitting scheduling conflict. A ±5 percent variance in the calculated total dose was allowed.
Secondary outcomes (3)
- measure
- Pathological Complete Response (pCR)
- timeFrame
- surgery following 3 cycles (21-day cycles) of chemotherapy
- description
- Pathological complete response was defined as the absence of any tumor cells.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * no prior therapy for rectal cancer * pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to surgery. * adequate organ function * Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1 * signed informed consent * at least 18 years of age * surgically sterile, postmenopausal (women) or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment. Exclusion Criteria: * concurrent administration of any other anti-tumor therapy * treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * serious concomitant systemic disorders * previously completed or withdrawn from this study * pregnant or breast-feeding * second primary malignancy * history of significant neurological or mental disorder, including seizures or dementia * inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs) * presence of clinically relevant third space fluid collections that cannot be controlled by drainage or other procedure prior to the study entry * inability or unwillingness to take folic acid, vitamin B12 or dexamethasone
References
Publications (0)
Data not yet available
No reference posted for this study.